# https://olumiant.lilly.com/ llms-full.txt
## Olumiant Treatment Options
[Skip to main content](https://olumiant.lilly.com/#maincontent)
Find out more about how
# Olumiant could be right for you
**Find out more about how**
Olumiant could be right for you
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**Olumiant® (O-loo-mē-ant) is a Janus kinase (JAK) inhibitor used to treat:**
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
**Choose a condition to learn more**
[Alopecia Areata](https://olumiant.lilly.com/alopecia-areata)
[Rheumatoid Arthritis](https://olumiant.lilly.com/rheumatoid-arthritis)
[Learn How to Save on Olumiant\\
\\
Right](https://olumiant.lilly.com/savings-support)
**Governmental beneficiaries excluded, terms and conditions apply.**
[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi)
[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg)
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant Information
https://olumiant.lilly.com/alopecia-areatahttps://olumiant.lilly.com/dosing-side-effectshttps://olumiant.lilly.com/hcphttps://olumiant.lilly.com/rheumatoid-arthritishttps://olumiant.lilly.com/savings-supporthttps://olumiant.lilly.com/sitemaphttps://olumiant.lilly.com/alopecia-areata/efficacy-resultshttps://olumiant.lilly.com/alopecia-areata/how-olumiant-workshttps://olumiant.lilly.com/alopecia-areata/olumiant-resultshttps://olumiant.lilly.com/alopecia-areata/patient-storieshttps://olumiant.lilly.com/alopecia-areata/taking-olumianthttps://olumiant.lilly.com/alopecia-areata/what-is-alopecia-areatahttps://olumiant.lilly.com/hcp/alopecia-areatahttps://olumiant.lilly.com/hcp/covid-19https://olumiant.lilly.com/hcp/rheumatoid-arthritishttps://olumiant.lilly.com/hcp/support-resourceshttps://olumiant.lilly.com/rheumatoid-arthritis/treatmenthttps://olumiant.lilly.com/rheumatoid-arthritis/what-is-olumianthttps://olumiant.lilly.com/hcp/alopecia-areata/efficacyhttps://olumiant.lilly.com/hcp/alopecia-areata/getting-patients-startedhttps://olumiant.lilly.com/hcp/alopecia-areata/patient-profilehttps://olumiant.lilly.com/hcp/alopecia-areata/safetyhttps://olumiant.lilly.com/hcp/alopecia-areata/videoshttps://olumiant.lilly.com/hcp/covid-19/accesshttps://olumiant.lilly.com/hcp/covid-19/dosing-administrationhttps://olumiant.lilly.com/hcp/covid-19/efficacyhttps://olumiant.lilly.com/hcp/covid-19/safetyhttps://olumiant.lilly.com/hcp/rheumatoid-arthritis/dosinghttps://olumiant.lilly.com/hcp/rheumatoid-arthritis/moahttps://olumiant.lilly.com/hcp/rheumatoid-arthritis/safetyhttps://olumiant.lilly.com/
## Olumiant for Alopecia Areata
[Skip to main content](https://olumiant.lilly.com/alopecia-areata#maincontent)
Olumiant is a prescription medication that is a Janus kinase (JAK) inhibitor, and is used to treat adults with severe alopecia areata.
# **Discover a once-daily pill for adults with severe alopecia areata**
You could regrow your hair. Olumiant showed significant hair regrowth in some adults, resulting in 80% scalp coverage at 36 weeks.\*
\*Up to 22% of people taking 2 mg once daily compared to up to 5% taking the inactive pill in clinical studies.
Up
View description
00:00
\[The words "Actor portrayal" animate in the upper left corner of the screen\]
00:01-00:04
\[A woman with severe alopecia areata takes a shower. The back of her head is shown, and she is missing hair.\]
**VO:** With severe alopecia areata,...
00:05-00:06
\[The camera follows a small tuft of hair falling down her shoulder, onto the shower floor.\]
**VO:** …you can lose your hair.
00:07-00:10
\[Within the hair, we see her hair figure sitting in the water current.\]
**VO:** Moments left behind. Time feels swept away by hair loss.
00:11-00:13 \[A second woman with severe alopecia areata wakes up to see hair on her pillow.\]
**Super:** Olumiant is a prescription medicine used to treat adults with severe alopecia areata.
**VO:** Now you can regrow your hair with Olumiant,...
00:14-00:18
\[Her hair figure is sitting on the pillow and gets disrupted by the spouse's shifting movement.\]
**Super:** Olumiant is a prescription medicine used to treat adults with severe alopecia areata.
**VO:** ...the first FDA-approved oral treatment for adults with severe alopecia areata.
00:19-00:22
\[The first woman is showering; you see her post-treatment hair.\]
**Super:** Some adults taking Olumiant achieved 80% scalp hair coverage at 36 weeks.\*
\*Up to 22% of people taking 2 mg once daily compared to up to 5% taking the inactive pill in clinical studies.
**VO:** Just one pill each day may significantly regrow your hair at 36 weeks.
00:23-00:25
\[The same woman in the shower, close up of the drain without a tuft of hair.\]
**Super:** Don't start Olumiant if you have an infection, it can lower your ability to fight them.
**VO:** Don’t start Olumiant if you have an infection,...
00:25-00:27
\[The same woman, exits the shower.\]
**Super:** Don't start Olumiant if you have an infection, it can lower your ability to fight them.
**VO:** …as it can lower your ability to fight them.
00:27-00:32
\[The same woman closes the shower door, walks toward the sunny window, and looks outside.\]
**Super:** Serious, sometimes fatal infections, blood clots, cancers such as lymphoma and skin cancer, serious allergic reactions, tears in the stomach or intestines, and changes in lab results have occurred.
**VO:** Serious, sometimes fatal infections, blood clots, cancers such as lymphoma and skin cancer,...
00:33-00:37
\[The second woman wakes up with post-treatment hair. Her partner is asleep next to her.\]
**Super:** Serious, sometimes fatal infections, blood clots, cancers such as lymphoma and skin cancer, serious allergic reactions, tears in the stomach or intestines, and changes in lab results have occurred.
**VO:** …serious allergic reactions, tears in the stomach or intestines, and changes in lab results have occurred.
00:38-00:43
\[The second woman wakes up with post-treatment hair. She looks over at her pillow, which doesn't have a tuft of hair. She turns toward the camera with a smile on her face.\]
**Super:** People 50 years and older with at least one heart disease risk factor have a higher risk of death, heart attack, stroke, and blood clots.
**VO:** People 50 years and older with at least one heart disease risk factor have a higher risk of death, heart attack, stroke, and blood clots.
00:43-00:50
\[The second woman and her spouse walk through the market, their arms intertwined.\]
**Super:** Tell your doctor if you have had Tuberculosis (TB), hepatitis B or C, are prone to infections, or have been somewhere fungal infections are common.
**VO:** Tell your doctor if you have had Tuberculosis (TB), hepatitis B or C, are prone to infections, or have been somewhere fungal infections are common.
00:51-00:55
\[The same woman holds up a bowl she finds and then cuts to her and her spouse talking to a vendor at the market\]
**Super:** Before starting and while taking Olumiant, your doctor should check for TB and do blood tests.
**VO:** Before starting and while taking Olumiant, your doctor should check for TB and do blood tests.
00:55-00:58
\[Olumiant logo, pill bottle, end card material appears on the screen\]
**Super:** Olumiant end card. Learn more at olumiant.lilly.com 1-844-LillyRx (1-800-545-5979)
For pricing information, please visit lillypricinginfo.com/olumiant or call 1-800-LillyRx. Olumiant® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
PP-BA-US-2427 01/2025 ©Lilly USA, LLC 2025. All rights reserved.
**VO:** Ask your doctor about Olumiant.
00:58-1:00
\[Lilly A MEDICINE COMPANY animates on a red background\]
“It has worked so well for me. The once-a-day pill is easy to take."
* * *
John, actual Olumiant patient with severe alopecia areata
John was compensated for his time.
## **Discover Olumiant**
Learn more about scalp hair regrowth and eyebrow & eyelash results
[**Explore Olumiant Results**\\
Right](https://olumiant.lilly.com/alopecia-areata/olumiant-results?section=explore-patient-photo)
[**Explore Patient Photos**\\
Right](https://olumiant.lilly.com/alopecia-areata/olumiant-results?section=explore-patient-photos)
[**Learn About Taking Olumiant**\\
Right](https://olumiant.lilly.com/alopecia-areata/taking-olumiant)
[**Find Out How Olumiant Works**\\
Right](https://olumiant.lilly.com/alopecia-areata/how-olumiant-works)
**Select Safety Information**
**Olumiant may cause serious side effects, including:**
**Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections you have worse. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection. If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
**Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and take a medicine in a class of medicines called Janus kinase (JAK) inhibitors.** Olumiant is a JAK inhibitor.
**Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, especially if you are a current or past smoker. Follow your doctor's advice about having your skin checked for skin cancer while taking Olumiant.
**Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant.
**Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots while taking Olumiant.
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant Dosing & Side Effects
[Skip to main content](https://olumiant.lilly.com/dosing-side-effects#maincontent)
# **Olumiant dosing & side effects**
## Discover a once-daily pill for adults with:
- **Severe alopecia areata**
- **Moderately to severely active rheumatoid arthritis**
## **Ask your healthcare provider about Olumiant**
Olumiant pills come in 2 mg and 4 mg strengths. Your healthcare provider will prescribe what is best for you.
- It is **not** an injection or a cream
- It can be taken **with or without** food
- It should be **taken exactly as prescribed**
(Not actual size)
# Most common side effects
When taking Olumiant, some people may experience any of the following **common side effects**.
The **most common side effects** of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The **most common side effects** of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects. **You can report side effects to the FDA at [1-800-FDA-1088](tel:1-800-FDA-1088) or [www.fda.gov/medwatch](https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program).**
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant Treatment Options
[Skip to main content](https://olumiant.lilly.com/hcp#maincontent)
**Information about the [Emergency Use Authorization for Baricitinib](http://www.baricitinibemergencyuse.com/)**
# See How Olumiant Can Help Certain Patients
## To get started, select a condition:
[Alopecia Areata](https://olumiant.lilly.com/hcp/alopecia-areata)
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
[Rheumatoid Arthritis](https://olumiant.lilly.com/hcp/rheumatoid-arthritis)
Olumiant is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.
[COVID-19](https://olumiant.lilly.com/hcp/covid-19)
Olumiant is indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
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[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
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[Yes](https://olumiant.lilly.com/)
## Olumiant for RA
[Skip to main content](https://olumiant.lilly.com/rheumatoid-arthritis#maincontent)
For adults with moderately to severely active RA for whom a TNF blocker did not work well enough.
# Envision a bright future with Olumiant
## The real pain of RA
The real pain of rheumatoid arthritis is seeing others do for you what you used to do for them. Olumiant can help give some people a better sense of control over their RA. And more control may allow you to do more for yourself and your loved ones.
[Discover Olumiant](https://olumiant.lilly.com/rheumatoid-arthritis/treatment)
## What is Olumiant?
Olumiant is a once-daily pill to treat adults with moderately to severely active rheumatoid arthritis (RA) who didn't find relief from biologic medicines called tumor necrosis factor (TNF) blockers, such as Humira® (adalimumab), Enbrel® (etanercept), and Remicade® (infliximab). It is not known if Olumiant is safe and effective in children.
[Find out more](https://olumiant.lilly.com/rheumatoid-arthritis/what-is-olumiant)
## Some people experienced quick relief for RA signs and symptoms
People who took Olumiant reported a 20% improvement in their RA signs and symptoms in as few as 7 days. For some, it may take up to 12 weeks to see results.
Discover how Olumiant can help you.
[Explore improvement](https://olumiant.lilly.com/rheumatoid-arthritis/what-is-olumiant)
### **Select Safety Information**
**Olumiant may cause serious side effects, including:**
**Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections you have worse. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection. If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
**Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and take a medicine in a class of medicines called Janus kinase (JAK) inhibitors.** Olumiant is a JAK inhibitor.
**Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, especially if you are a current or past smoker. Follow your doctor's advice about having your skin checked for skin cancer while taking Olumiant.
**Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant.
**Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots while taking Olumiant.
## Setting goals with your doctor
You may not know how well your current TNF biologic is working or what to expect from treatment. Thinking about treatment goals can be a great start. It can help you focus on what you may want to do if your RA was more manageable. This can help you and your doctor have a better conversation about what is important to you and what steps to take next.
[Talking to your doctor](https://olumiant.lilly.com/rheumatoid-arthritis/what-is-olumiant?section=talking-to-your-doctor)
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant Savings Support
[Skip to main content](https://olumiant.lilly.com/savings-support#maincontent)
## **Access savings and support with Lilly Support Services™ for Olumiant®**
[Enroll Here\\
\\
Right](https://enrollment.olumiant.com/copay/olumiant/contact-info)
**Pay As Little As**
If you have a **commercial drug insurance plan that covers Olumiant®**, you may be eligible to pay as little as a $5 copay for a 30-day supply each time you fill your prescription.\*
If you have a **commercial drug insurance plan that does not cover Olumiant®**, you may be eligible to pay as little as $25 for each 30-day supply.\*
**Governmental beneficiaries excluded, terms and conditions apply.**
## Terms and Conditions
By enrolling in the Olumiant Savings Card Program (“Program”) and using the Olumiant Savings Card (“Card”), you attest that you meet the eligibility criteria, agree to, and will comply with the terms and conditions described below:
**Card Eligibility:**
(1) You have been prescribed Olumiant® (baricitinib) for an approved use consistent with FDA-approved product labeling;
(2) You are enrolled in a commercial drug insurance plan;
**(3) You are not enrolled in any state, federal, or government funded healthcare program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state prescription drug assistance program;**
(4) You are a resident of the United States or Puerto Rico; and
(5) You are 18 years of age or older.
**Card Terms and Conditions:**
For patients with commercial drug insurance coverage for Olumiant: You must have commercial drug insurance that covers Olumiant and a prescription for an approved use consistent with FDA-approved product labeling to pay as little as $5 for a 1-month prescription fill of Olumiant. Month is defined as 30 days. Card must be first used by no later than 12/31/2025. Card savings are subject to a maximum monthly savings of wholesale acquisition cost plus usual and customary pharmacy charges and a separate maximum annual savings of up to $9,200 per calendar year. Card may be used for up to a maximum of 13 prescription fills per calendar year and up to a maximum of 24 prescription fills over the lifetime of the Program, subject to the previously stated maximum monthly and annual savings limit. Except where prohibited by applicable state law, Card monthly and annual savings are reduced if Lilly identifies that you are enrolled in a plan or program, sometimes called a maximizer plan, that adjusts your cost sharing amount to be equal to or include some portion of the savings provided by the Card and attempts to prevent the savings from this Card from being applied to your out-of-pocket costs, including but not limited to copayments, coinsurances, and deductibles (“Maximizer”). If the Program identifies you are enrolled in a Maximizer, Card savings are reduced to a maximum annual savings of up to $6,000 per calendar year. If you have reason to believe that the Program erroneously identified enrollment in a Maximizer, please call the Olumiant Savings Card Program at 1-844-658-6426. Participation in the Program requires a valid patient HIPAA authorization upon enrollment into the Program. Subject to Lilly USA, LLC's right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions which may occur at Lilly’s sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
For patients with commercial drug insurance who do not have coverage for Olumiant: You must have commercial drug insurance that does not cover Olumiant and a prescription for an approved use consistent with FDA-approved product labeling to pay as little as $25 for a 1-month supply of Olumiant. Month is defined as 30 days. Card must be first used by no later than 12/31/2025. Card savings are subject to a maximum monthly savings and a separate maximum annual savings. Card may be used for up to a maximum of 13 prescription fills per year and up to a maximum 24 prescription fills over the lifetime of the Program, subject to the maximum monthly and annual savings limit. Card must be first used by no later than 12/31/2025. Participation in the Program requires submission of a prior authorization (PA) prior to the first prescription fill. If coverage is denied, an appeal must be submitted prior to 5th month prescription fill. To remain eligible for the Program, a new PA, appeal, or medical exception must be submitted prior to the 13th prescription fill and as required by Lilly at its sole discretion. Participation in the Program requires a valid patient HIPAA authorization to remain in the Program. Subject to Lilly USA, LLC's right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions, which may occur at Lilly's sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
**Additional Program Terms and Conditions**
If you have an insurance plan that is participating in an alternate funding program (“AFP”) that requires you to apply to the Olumiant Savings Card Program or otherwise pursue specialty drug prescription coverage through an alternate funding vendor as a condition of, requirement for, or prerequisite to coverage of Olumiant, you are not eligible for and are prohibited from using the Olumiant Savings Card Program. AFPs include programs where coverage, reimbursement, or patient out of pocket costs for a product in some way vary based on the availability of a manufacturer co-pay program. AFPs may modify, delay, deny, restrict, or withhold insurance benefits or coverage from patients, or exclude Lilly products from coverage contingent upon a member's use of Olumiant Savings Card Program. You agree to inform Olumiant Savings Card Program if you are or become a member of such an alternative funding program. You are responsible for any applicable taxes, fees, and any amount that exceeds the applicable monthly or annual maximum Card savings. Monthly and annual maximum savings are set at Lilly's sole and absolute discretion and may be changed with or without notice at any time for any reason. At its sole discretion and with or without notice, Lilly may reduce, eliminate, or otherwise modify the Card savings for any reason, including but not limited to if your commercial drug insurance plan imposes additional requirements which limits or prevents you from receiving coverage for Olumiant, only allows partial coverage for Olumiant, removes coverage for Olumiant and requires you to utilize the Card, does not provide a material level of financial assistance for the cost of Olumiant, or does not apply Card payments to satisfy your co-payment, deductible, or coinsurance for Olumiant. Card savings are not valid for: Massachusetts residents if an AB-rated generic equivalent is available; California residents if an FDA-approved therapeutic equivalent is available. You must meet the Card eligibility criteria, terms and conditions every time you use the Card. If at any time you begin receiving drug coverage under any state, federal, or government funded healthcare program, you understand that you will no longer be eligible for the Olumiant Savings Card and agree to call the Olumiant Savings Card Program at 1-844-658-6426 to stop participation. Card activation is required. You may not seek reimbursement from your health insurance, any third party, or any health savings, flexible spending, or other healthcare reimbursement accounts, for any amount of the savings received through the Card. By utilizing the Card, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you will notify your Insurance Carrier of your redemption of the Card. Card savings cannot be combined or utilized with any other program, discount, discount card, cash discount card, coupon, incentive, or similar offer involving Olumiant. You agree that this Card savings is intended solely for the benefit of you, the patient, and that the Card benefits are nontransferable. It is prohibited for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade, or to counterfeit the Card. **THIS CARD IS NOT INSURANCE**. Lilly has the sole right to interpret and apply Card eligibility criteria, and terms and conditions. Card eligibility, and terms and conditions may be terminated, rescinded, revoked, or amended by Lilly at any time without notice and for any reason. Lilly's sole discretion to terminate, rescind, revoke, or amend Card eligibility and/or Card terms and conditions includes the right to terminate any individual Card if Lilly determines, in its sole discretion, that a patient does not satisfy the Card's eligibility criteria or is using or has attempted to use the Card inconsistently with these terms and conditions. Eligibility criteria, and terms and conditions for the Olumiant Savings Card Program may change from time to time; the most current version can be found at [https://www.olumiant.lilly.com/savings-support](https://olumiant.lilly.com/savings-support). You may be required to obtain a new Card, including if any Card terms and conditions have been terminated, rescinded, revoked, or amended by Lilly. Card void where prohibited by law. Subject to Lilly's right to terminate, rescind, revoke or amend Card eligibility criteria and/or Card terms and conditions, which may occur at Lilly's sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
A Lilly Support Services™ for Olumiant Companion in Care™† team member can work with you to help make your medication more affordable.
†A Companion in Care provided by Lilly Support Services™ for Olumiant is not a medical professional. Your doctor is your source for medical advice.
[Enroll Here for Savings\\
\\
Right](https://enrollment.olumiant.com/copay/olumiant/contact-info)
**Are you eligible for savings?**
To find out, call Lilly Support Services™ for Olumiant at 1-800-LillyRx (1-800-545-5979). A Companion in Care™ will be able to answer your questions.
**What is Lilly Support Services™ for Olumiant?**
Lilly Support Services™ for Olumiant® is a support program that enables you to connect with the Companion in Care™ team\*\- a group of people available to help you with personalized assistance, resources, and support throughout your treatment.
**Enroll in Lilly Support Services™ and Start Saving**
[Enroll Here for Savings\\
\\
Right](https://enrollment.olumiant.com/copay/olumiant/contact-info)
If you do not qualify for a savings card, you can still enroll in Lilly Support Services™ by calling [1-800-LillyRx (1-800-545-5979)](tel:18005455979).
To get your savings card,\* we need your HIPAA authorization to work on your behalf to ensure you're at the right specialty pharmacy and paying as little as $5 or $25 a month.
As a reminder, HIPAA is the Health Insurance Portability and Accountability Act. It provides data privacy and security to protect your medical information.
**What to expect once you enroll**
1. Watch out for an email and/or text welcoming you to the program!
2. A Companion in Care will call to talk through how Lilly Support Services™ can support you, check your insurance coverage on your behalf before you start treatment, and answer any questions you may have.†
3. You will receive a call from a Companion in Care representative to ensure you’ve received your first delivery of Olumiant®. Be sure to save [1-800-545-5979](tel:18005455979) to your contacts so you know when a Companion in Care is calling.
†Your Companion in Care provided is not a medical professional. Your doctor is your source of medical advice.
[Enroll Now\\
\\
Right](https://enrollment.olumiant.com/copay/olumiant/contact-info)
**Olumiant® Support**
**Meet your Olumiant® support team**
Once your doctor prescribes Olumiant®, there are key team members who may reach out to help you get started.
**Your Companion in Care™†**
Your Lilly Support Services™ for Olumiant Companion in Care contact coordinates with your doctor’s office, specialty pharmacy, and insurance company to check your insurance coverage, determine specialty pharmacy options, and assist in savings enrollment.†
†Your Companion in Care provided is not a medical professional. Your doctor is your source for medical advice.
**Your insurance company**
Once a prescription is received, your insurance company will determine coverage, identify how much Olumiant® may cost you, and coordinate with the specialty pharmacy identified by your doctor.
**Your specialty pharmacy**
Your specialty pharmacy handles specialty medications, like Olumiant®. Your doctor will send your prescription to a specialty pharmacy. It is important that the specialty pharmacy is in your insurance network. Once your insurance company approves Olumiant®, your specialty pharmacy will contact you to coordinate medication pick up or delivery.
**Be sure to share your savings card with your specialty pharmacy.**
**Learn about the specialty pharmacy process**
**Step 1:**
Doctor sends specialty prescription
**Step 2:**
Insurance company determines coverage and coordinates with specialty pharmacy
**Step 3:**
Specialty pharmacy prepares medication
**Step 4:**
Specialty pharmacy calls you to discuss payment and delivery
**Step 5:**
Medication is sent to your home
To connect with a Lilly Support Services™ representative any time you have a question, call [1-800-LillyRx (1-800-545-5979).](tel:18005455979)
**Have concerns about paying for Olumiant® during this time?**
We're here to help. Contact Lilly Support Services™ at 1-800-LillyRx ( [1-800-545-5979](tel:18005455979)) for more information.
**How to enroll**
**How can I enroll in Lilly Support Services™ for Olumiant?**
_There are a number of different ways to get started with Lilly Support Services™:_
- Ask your doctor at your next visit
- Enroll online
[here](https://olumiant.lilly.com/savings-support#lilly-support-services)
- Call [1-800-LillyRx](tel:18005455979) ( [1-800-545-5979](tel:18005455979))
- Enroll with the Lilly Together™ mobile app
"I am very thankful for this program. Without the program, I would not have been able to afford the medication and would not be in treatment today.”
* * *
John, actual Olumiant patient with severe alopecia areata
John was compensated for his time.
**Lilly Together™ app**
**Discover key support options with the Lilly Together app**
The Lilly Together™ app is a resource to help you manage your treatment, putting you in control of visualizing and tracking your treatment journey.
**How to download the Lilly Together app**
To get started, **search for “Lilly Together” in the App Store® or on Google Play™** to download the mobile app.
Download the Lilly Together mobile app to enroll in Olumiant® savings and support. The app is a resource to help you on your treatment journey. With the Lilly Together app, you can access your Olumiant savings card and connect with your Companion in Care.
†A Companion in Care provided by Lilly Support Services™ for Olumiant is not a medical professional. Your doctor is your source for medical advice.
[](https://e.lilly/togetherappios)
[](https://e.lilly/togetherappandroid)
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant Sitemap
[Skip to main content](https://olumiant.lilly.com/sitemap#maincontent)
# Sitemap
[For Consumers](https://olumiant.lilly.com/)
- [Alopecia Areata](https://olumiant.lilly.com/alopecia-areata)
- [What is Alopecia Areata?](https://olumiant.lilly.com/alopecia-areata/what-is-alopecia-areata)
- [Olumiant Results](https://olumiant.lilly.com/alopecia-areata/olumiant-results)
- [Taking Olumiant](https://olumiant.lilly.com/alopecia-areata/taking-olumiant)
- [How Olumiant Works](https://olumiant.lilly.com/alopecia-areata/how-olumiant-works)
- [Patient Stories](https://olumiant.lilly.com/alopecia-areata/patient-stories)
- [Rheumatoid Arthritis](https://olumiant.lilly.com/rheumatoid-arthritis)
- [Dosing & Side Effects](https://olumiant.lilly.com/dosing-side-effects)
- [Savings & Support](https://olumiant.lilly.com/savings-support)
- [Lilly Support Services™](https://olumiant.lilly.com/savings-support#lilly-support-services)
- [Olumiant® Support](https://olumiant.lilly.com/savings-support#olumiant-support)
- [How to Enroll](https://olumiant.lilly.com/savings-support#how-to-enroll)
- [Lilly Together™ App](https://olumiant.lilly.com/savings-support#lilly-together-app)
- [Pricing](https://www.lillypricinginfo.com/olumiant)
[For Healthcare Providers](https://olumiant.lilly.com/hcp)
Alopecia Areata
- [Alopecia Areata Home](https://olumiant.lilly.com/hcp/alopecia-areata)
- [Patient Profile & Mechanism of Action (MOA)](https://olumiant.lilly.com/hcp/alopecia-areata/patient-profile)
- [Patient Profile](https://olumiant.lilly.com/hcp/alopecia-areata/patient-profile?section=patient-profile)
- [JAK-STAT Pathway](https://olumiant.lilly.com/hcp/alopecia-areata/patient-profile?section=jak-stat-pathway)
- [Mechanism of Action](https://olumiant.lilly.com/hcp/alopecia-areata/patient-profile?section=moa)
- [Efficacy](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy)
- [SALT](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=salt)
- [Study Designs](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=study-designs)
- [Patient Baseline Characteristics](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=baseline-characteristics)
- [Scalp Hair Results](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=scalp-hair-results)
- [Eyebrow and Eyelash Results](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=eyebrow-eyelash-results)
- [Patient Photos](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=patient-photos)
- [Long Term Results](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=long-term-results)
- [Safety](https://olumiant.lilly.com/hcp/alopecia-areata/safety)
- [Adverse reactions through week 36](https://olumiant.lilly.com/hcp/alopecia-areata/safety?section=adverse-reactions-week-36)
- [Adverse events of special interest](https://olumiant.lilly.com/hcp/alopecia-areata/safety?section=adverse-events-special-interest)
- [Getting Started](https://olumiant.lilly.com/hcp/alopecia-areata/getting-patients-started)
- [Dosing and Administration](https://olumiant.lilly.com/hcp/alopecia-areata/getting-patients-started?section=dosing)
- [Lab Monitoring](https://olumiant.lilly.com/hcp/alopecia-areata/getting-patients-started?section=lab-monitoring)
- [Access](https://olumiant.lilly.com/hcp/alopecia-areata/getting-patients-started?section=access)
- [Olumiant Videos](https://olumiant.lilly.com/hcp/alopecia-areata/videos)
Rheumatoid Arthritis
- [Efficacy](https://olumiant.lilly.com/hcp/rheumatoid-arthritis)
- [BEACON Study Design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
- [BEACON Patient Characteristics](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=patient-characteristics)
- [BEACON ACR Response](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-acr-response-rates)
- [BEACON ACR Pain Component Data](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-acr-pain-data)
- [BEACON HAQ-DI Results](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-haq-di-results)
- [BEACON DAS28-CRP Results](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-das28-results)
- [Additional Data](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=build-additional-data)
- [Safety](https://olumiant.lilly.com/hcp/rheumatoid-arthritis/safety)
- [Common Adverse Events](https://olumiant.lilly.com/hcp/rheumatoid-arthritis/safety?section=adverse-events)
- [Discontinuation Rates Due to Adverse Events](https://olumiant.lilly.com/hcp/rheumatoid-arthritis/safety?section=additional-safety-data)
- [Adverse Events of Special Interest](https://olumiant.lilly.com/hcp/rheumatoid-arthritis/safety?section=adverse-events-si)
- [Patient Profile & Mechanism of Action (MOA)](https://olumiant.lilly.com/hcp/rheumatoid-arthritis/moa)
COVID-19
- [About Olumiant](https://olumiant.lilly.com/hcp/covid-19)
- [Timeline](https://olumiant.lilly.com/hcp/covid-19?section=timeline)
- [Patient Profile](https://olumiant.lilly.com/hcp/covid-19?section=patient-profile)
- [Mechanism of Action (MOA)](https://olumiant.lilly.com/hcp/covid-19?section=moa)
- [Efficacy](https://olumiant.lilly.com/hcp/covid-19/efficacy)
- [ACTT-2](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=actt-2)
- [COV-BARRIER](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=cov-barrier)
- [COV-BARRIER OS 7 Addendum](https://olumiant.lilly.com/hcp/covid-19?section=os7-addendum)
- [Dosage & Administration](https://olumiant.lilly.com/hcp/covid-19/dosing-administration)
- [Dosage and Administration](https://olumiant.lilly.com/hcp/covid-19/dosing-administration?section=dosing)
- [Alternative Administration](https://olumiant.lilly.com/hcp/covid-19/dosing-administration?section=administration)
- [Safety](https://olumiant.lilly.com/hcp/covid-19/safety)
- [Access](https://olumiant.lilly.com/hcp/covid-19/access)
- [Savings & Support](https://olumiant.lilly.com/hcp/support-resources)
- [Lilly Support Services™ Enrollment Forms](https://olumiant.lilly.com/hcp/support-resources?section=enrollment-forms)
- [Specialty Pharmacy](https://olumiant.lilly.com/hcp/support-resources?section=specialty-pharmacy)
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant Efficacy Results
[Skip to main content](https://olumiant.lilly.com/alopecia-areata/efficacy-results#maincontent)
Olumiant is a prescription medication that is a Janus kinase (JAK) inhibitor, and is used to treat adults with severe alopecia areata.
# Olumiant for alopecia areata
**If you're an adult with severe alopecia areata**
## Significant hair regrowth could be within your grasp at 36 weeks
In clinical studies, some adults with severe alopecia areata taking Olumiant achieved **80% scalp hair coverage** at 36 weeks.
For those taking Olumiant 4 mg once daily, **some saw 90% or greater** scalp hair coverage at 36 weeks, and some saw 80% or greater scalp hair coverage as early as 24 weeks.
The recommended dosage is 2 mg once daily for most patients, but certain patients may be treated with 4 mg once daily. Your healthcare provider will determine the right dosage for you.
* * *
In patients with substantial eyebrow and eyelash hair loss, some people taking Olumiant 4 mg once daily saw improvement in eyebrow and eyelash coverage at 36 weeks
The recommended dosage is 2 mg once daily for most patients, but certain patients may be treated with 4 mg once daily. Your healthcare provider will determine the right dosage for you.
Connect with a community that understands
We've partnered with the National Alopecia Areata Foundation to help you discover insights, understanding, and inspiration from a group of people who know what you're going through.
[Connect with NAAF](https://www.naaf.org/)
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant for Alopecia Areata
[Skip to main content](https://olumiant.lilly.com/alopecia-areata/how-olumiant-works#maincontent)
# **How Olumiant works**
Olumiant is a Janus kinase (JAK) inhibitor that works inside the body. It is thought to disrupt an immune signaling pathway involved in alopecia areata.
It is not currently known how inhibiting these immune signals contributes to the therapeutic effects of Olumiant.
**Select Safety Information**
**Olumiant may cause serious side effects, including:**
**Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant Results Overview
[Skip to main content](https://olumiant.lilly.com/alopecia-areata/olumiant-results#maincontent)
Olumiant is a prescription medication that is a Janus kinase (JAK) inhibitor, and is used to treat adults with severe alopecia areata.
# **Olumiant results in alopecia areata**
In clinical studies, some adults with severe alopecia areata taking Olumiant achieved 80% scalp hair coverage at 36 weeks.\*
**MOVE SLIDER TO THE RIGHT**
**BEFORE TREATMENT**
**AT 36 WEEKS**
Move by clicking and dragging or using your arrow keys to see the difference between the two images
Left
Right
Actor portrayal
\*Up to 22% of people taking 2 mg once daily, up to 35% taking 4 mg once daily, and up to 5% taking the inactive pill once daily.
**MOVE SLIDER TO THE RIGHT**
**BEFORE TREATMENT**
**AT 36 WEEKS**
Move by clicking and dragging or using your arrow keys to see the difference between the two images
Left
Right
Actor portrayal
\*Up to 22% of people taking 2 mg once daily, up to 35% taking 4 mg once daily, and up to 5% taking the inactive pill once daily.
[**Explore Patient Photos**\\
Right](https://olumiant.lilly.com/alopecia-areata/olumiant-results?section=explore-patient-photos)
**If you're an adult with severe alopecia areata**
## **Significant scalp hair regrowth could be within your grasp at 36 weeks**
Some adults with 50% to 100% scalp hair loss saw significant hair regrowth with Olumiant, resulting in **80% scalp coverage at 36 weeks.†**
†Up to 22% of people taking 2 mg once daily compared to up to 5% taking the inactive pill in clinical studies.
Actor portrayal
If you're an adult with severe alopecia areata
## **Just one pill each day could significantly regrow your hair**
For those taking 4 mg once daily, some saw **90% or greater** scalp hair coverage **at 36 weeks,‡** and some saw **80% or greater** scalp hair coverage **as early as 24 weeks.§**
The recommended dosage is 2 mg once daily for most patients, but certain patients may be treated with 4 mg once daily. Your healthcare provider will determine the right dosage for you.
‡Up to 26% of people taking 4 mg once daily compared to up to 4% taking the inactive pill in clinical studies.
§Up to 28% of people taking 4 mg once daily compared to up to 5% taking the inactive pill in clinical studies.
Actor portrayal
Actor portrayal
If you're an adult with severe alopecia areata
## **You could see visible improvement in eyebrow and eyelash coverage**
In adults with substantial eyebrow and eyelash hair loss, some taking Olumiant 4 mg once daily **saw improvement in eyebrow and eyelash coverage** at 36 weeks.
The recommended dosage is 2 mg once daily for most patients, but certain patients may be treated with 4 mg once daily. Your healthcare provider will determine the right dosage for you.
Actor portrayal
“I have been taking Olumiant for a while now. It's so amazing to have hair again, to run my fingers through it, to feel it flowing in the breeze.”
* * *
Laura, actual Olumiant patient with severe alopecia areata
Laura was compensated for her time.
If you're an adult with severe alopecia areata
## **Just one pill each day could significantly regrow your hair**
In clinical studies, some adults saw 80% scalp hair coverage at 36 weeks.\* For those taking Olumiant 4 mg once daily, some adults achieved:
- 90% or greater scalp hair coverage at 36 weeks†
- 80% or greater scalp hair coverage as early as 24 weeks‡
In clinical studies:
\*Up to 22% of people taking 2 mg once daily compared to up to 5% taking the inactive pill.
†Up to 26% of people taking 4 mg once daily compared to up to 4% taking the inactive pill.
‡Up to 28% of people taking 4 mg once daily compared to up to 5% taking the inactive pill.
**If you're an adult with severe alopecia areata**
## **See the difference Olumiant could make**
**Visible results with Olumiant at 36 weeks**
2 mg once daily
Down
2 mg once daily
4 mg once daily
**Adult treated with 2 mg once daily**
**Before Starting Treatment**
**49%** Scalp Hair Coverage
**Results with Olumiant at week 12**
**At Week 36**
**86%** Scalp Hair Coverage
Clinical trial patient treated with Olumiant 2 mg once daily for 36 weeks. Hairstyles may influence the appearance of scalp hair coverage. Individual results may vary.
The recommended dosage is 2 mg once daily for most patients, but certain patients may be treated with 4 mg once daily. Your healthcare provider will determine the right dosage for you.
**Your results with Olumiant may be different from those shown here.**
**Adult treated with 4 mg once daily**
**Before Starting Treatment**
**0%** Scalp Hair Coverage
**Results with Olumiant at week 12**
**At Week 36**
**86%** Scalp Hair Coverage
Clinical trial patient treated with Olumiant 4 mg once daily for 36 weeks. Hairstyles may influence the appearance of scalp hair coverage. Individual results may vary.
The recommended dosage is 2 mg once daily for most patients, but certain patients may be treated with 4 mg once daily. Your healthcare provider will determine the right dosage for you.
**Your results with Olumiant may be different from those shown here.**
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Laura's Olumiant Journey
[Skip to main content](https://olumiant.lilly.com/alopecia-areata/patient-stories#maincontent)
# **Patient Stories**
Laura, an actual Olumiant patient
Scroll Down
Down
**Patient Stories**
**Laura, an actual Olumiant patient**
Olumiant is a prescription medication that is a Janus kinase (JAK) inhibitor, and is used to treat adults with severe alopecia areata.
## Meet Laura
It started with a tiny bald spot on the back of her head. Then clumps of hair falling out in the shower. Laura consulted with her doctor, ultimately resulting in a diagnosis of severe alopecia areata.
Over the next few years, Laura found different ways to hide her appearance. Through it all, there wasn’t a day that passed she didn’t miss having her hair.
That's when her Olumiant journey began. Watch Laura's story below.
_Laura was compensated for her time. Individual results may vary._
Up
Video Transcript
**00:00**
Caption + Graphic: Olumiant logo, “Olumiant is a prescription medication that is a Janus kinase (JAK) inhibitor, and is used to treat adults with severe alopecia areata. Olumiant may cause serious side effects, including: Serious infections, increased risk of death, cancer and immune system problems, increased risk of cardiovascular events and blood clots. Please see the Indications and Safety Summary with Warnings at the end of the video. Statements and visuals in this video are unique to the patient's individual experience on Olumiant for severe alopecia areata. Individual results may vary. Talk to your doctor to see if Olumiant is right for you. Participants were compensated for their time.”
**00:19**
\[A woman appears in a shadow with a spotlight illuminating behind her. She begins doing yoga.\]
VO Laura: Having been a performing artist for almost my entire life, I spent so much time in the spotlight. After I lost my hair, I didn't want people to look at me.
**00:36**
\[The woman sits in a chair, talking to an interviewer off-camera.\]
VO Laura: My name is Laura. I was diagnosed with severe alopecia areata in 2008.
**00:48**
\[Photos and videos of the woman appear as a montage. She is seen doing yoga, performing as a ballerina, and in a video as an aerialist.\]
VO Laura: As a performer, your hairstyle is part of the character that you play. I would put it up into a bun, usually for a classical role, or it would be free and flowing if I were doing a more contemporary dance. Not having that part of me and having that identity taken away was devastating.
Caption: “Laura is wearing a wig, which does not depict hair growth while on Olumiant.”
**1:10**
\[The woman continues speaking to the interviewer off-camera. She gestures to the location on her head where she initially discovered her hair loss.\]
VO Laura: I remember distinctly being in bed one morning, rolling over and just laying on my arm and my hand randomly felt a perfectly bare, smooth spot of skin.
**1:22**
\[The woman is shown closeup as she looks into the mirror.\]
VO Laura: I would be in the shower and clumps...
**1:24**
\[The frame switches to the back of the woman’s head; her reflection in the mirror is blurred.\]
VO Laura: ...of hair would be falling out. I had noticed a lot more hair than usual...
**1:28**
\[The woman looks into the mirror.\]
VO Laura: ...on my hairbrush, and I was scared. There was a lot of confusion.
**1:34**
\[The woman holds a handheld mirror.\]
VO Laura: There was blaming myself.
**1:36**
\[The woman is shown closeup as she looks into the mirror.\]
VO Laura: I didn't know what I did to cause this.
**1:38**
\[The woman looks into the mirror, her reflection blurred.\]
VO Laura: I had lost all my eyebrows. I had lost all my eyelashes. So, getting ready in the morning, not only would I have to, you know...
**1:46**
\[Photos of the woman in a wig or bandana appear as a montage.\]
VO Laura: ...put my bandana on or put my wig on if I was getting dressed up. I would have to find solutions to also look like I had eyebrows and eyelashes.
Caption: “Laura is wearing a wig, which does not depict hair growth while on Olumiant.”
**1:58**
\[The woman does yoga.\]
VO Laura: It was really time to come out of hiding, to share what was going on with me. And...
**2:04**
\[The woman’s reflection is seen in a shop window as she walks into a yoga studio.\]
VO Laura: ...despite the fact of embracing who I was, there really wasn't a day that went by that I didn't wish for my hair...
**2:11**
\[The woman’s hands are shown closeup in a yoga pose.\]
VO Laura: ...back. I tried...
**2:14**
\[The woman does yoga.\]
VO Laura: ...many different treatments. Nothing really gave me the result that I wanted.
**2:23**
\[The woman walks by a shop window.\]
VO Laura: Once I had seen that Olumiant had been FDA approved for the treatment of severe alopecia areata in adults...
Caption+ Graphic: Olumiant Logo, “Olumiant is a prescription medicine used to treat adults with severe alopecia areata. Please see the Indications and Safety Summary with Warnings on the website.”
**2:31**
\[The woman sits in a chair, talking to an interviewer off-camera.\]
VO Laura: ...I went to my dermatologist. I actually found out that I was going to be her first patient with alopecia areata that she would be treating with Olumiant. So, I was very excited that we could learn together, and we could see the possibilities of what Olumiant could do for me.
Graphic: Olumiant Logo
**2:48**
\[Photos of the woman’s head while taking Olumiant appear as a montage.\]
VO Laura: I obtained my prescription in August of 2022, and that's when I began my Olumiant journey.
Caption + Graphic: Olumiant Logo, “Photos taken August 2022”
**2:55**
\[The woman sits in a chair, talking to an interviewer off-camera.\]
VO Laura: I have been taking Olumiant for a while now.
Caption + Graphic: Olumiant Logo, “In clinical trials of adults with severe alopecia areata, some patients taking Olumiant saw 80% or greater scalp hair coverage at 36 weeks.\* \*Up to 22% of those taking Olumiant 2 mg daily, up to 35% of those taking Olumiant 4 mg daily, and up to 5% of those taking the inactive pill (placebo).”
**2:58**
\[The woman walks into a workout space.\]
VO Laura: And it's...
Caption + Graphic: Olumiant Logo, “In clinical trials of adults with severe alopecia areata, some patients taking Olumiant saw 80% or greater scalp hair coverage at 36 weeks.\* \*Up to 22% of those taking Olumiant 2 mg daily, up to 35% of those taking Olumiant 4 mg daily, and up to 5% of those taking the inactive pill (placebo).”
**2:59**
\[The woman sets up her yoga mat to begin her practice.\]
VO Laura: ...so...
Caption + Graphic: Olumiant Logo, “In clinical trials of adults with severe alopecia areata, some patients taking Olumiant saw 80% or greater scalp hair coverage at 36 weeks.\* \*Up to 22% of those taking Olumiant 2 mg daily, up to 35% of those taking Olumiant 4 mg daily, and up to 5% of those taking the inactive pill (placebo).”
**3:00**
\[The woman does yoga.\]
VO Laura: ...amazing to have hair again.
Caption + Graphic: Olumiant Logo, “In clinical trials of adults with severe alopecia areata, some patients taking Olumiant saw 80% or greater scalp hair coverage at 36 weeks.\* \*Up to 22% of those taking Olumiant 2 mg daily, up to 35% of those taking Olumiant 4 mg daily, and up to 5% of those taking the inactive pill (placebo).”
**3:01**
\[The woman sits in a chair, talking to an interviewer off-camera.\]
VO Laura: To run my fingers through...
Caption + Graphic: Olumiant Logo, “In clinical trials of adults with severe alopecia areata, some patients taking Olumiant saw 80% or greater scalp hair coverage at 36 weeks.\* \*Up to 22% of those taking Olumiant 2 mg daily, up to 35% of those taking Olumiant 4 mg daily, and up to 5% of those taking the inactive pill (placebo).”
**3:03**
\[The woman touches her hair and watches her reflection as she walks by a window.\]
VO Laura: ...it, to feel it flowing...
Caption + Graphic: Olumiant Logo, “In clinical trials of adults with severe alopecia areata, some patients taking Olumiant saw 80% or greater scalp hair coverage at 36 weeks.\* \*Up to 22% of those taking Olumiant 2 mg daily, up to 35% of those taking Olumiant 4 mg daily, and up to 5% of those taking the inactive pill (placebo).”
**3:04**
\[The woman looks at the sun setting over the ocean.\]
VO Laura: in the breeze.
Caption + Graphic: Olumiant Logo, “In clinical trials of adults with severe alopecia areata, some patients taking Olumiant saw 80% or greater scalp hair coverage at 36 weeks.\* \*Up to 22% of those taking Olumiant 2 mg daily, up to 35% of those taking Olumiant 4 mg daily, and up to 5% of those taking the inactive pill (placebo).”
**3:06**
\[The woman sits in a chair, talking to an interviewer off-camera. She gestures to her hair.\]
VO Laura: My routine is so easy now. I get out of the shower, I put a little bit of product in it, and I let it do its thing.
Caption + Graphic: Olumiant Logo, “In patients with substantial eyebrow and eyelash hair loss, some people taking Olumiant 4mg once daily saw improvement in eyebrow and eyelash coverage at 36 weeks.”
**3:14**
\[The woman looks into the mirror and applies makeup.\]
VO Laura: Maybe I'll brush on a little bit of mascara and a touch of eyeliner, and I'm ready to go in about 5 minutes.
Caption + Graphic: Olumiant Logo, “The recommended dosage is 2 mg once daily for most patients, but certain patients may be treated with 4 mg once daily. Your healthcare provider will determine the right dosage for you.”
**3:20**
\[The woman is getting ready and going for a hike with her husband.\]
VO: Don't start Olumiant if you have an infection as it can lower your...
Caption + Graphic: Olumiant Logo, “Before starting and while taking Olumiant, your doctor should check for tuberculosis (TB) and do blood tests.”
**3:23**
\[The woman is on a hike with her husband; they take a selfie.\]
VO: ...ability to fight infections, serious sometimes fatal infections blood clots, cancers such as lymphoma...
Caption + Graphic: Olumiant Logo, “Tell your doctor if you have had TB, hepatitis B or C, are prone to infections, or have been somewhere fungal infections are common.“
**3:29**
\[The woman does yoga.\]
VO: ...and skin cancer. Serious allergic reactions...
Caption + Graphic: Olumiant Logo, “Serious allergic reactions can include rash (hives), trouble breathing, feeling faint or dizzy, or swelling of lips, tongue, or throat.”
**3:32**
\[The woman’s hand is shown closeup doing yoga. The frame shows the woman’s whole body doing yoga. The woman is on the beach and looks at the ocean.\]
VO: ...tears in the stomach or intestines and changes in lab results have occurred. People 50 years and older with at least one heart disease
Caption + Graphic: Olumiant Logo, “Tell your doctor if you have had cancer, heart problems, stroke, or blood clots.”
**3:39**
\[The woman looks at the sunset over the ocean.\]
VO: ...risk factor, have a higher risk of death, heart attack, stroke and blood clots.
Caption + Graphic: Olumiant Logo, “Please see the Indications and Safety Summary with Warnings on the website.”
**3:43**
\[The woman steps into a spotlight. She performs aerial.\]
VO Laura: I know that when people are looking at me, they're not seeing the thing that makes me stand out and makes me so different. They're seeing who I truly feel like I am. For any other adults out there with severe alopecia areata, I know how frustrating and devastating this condition can be. It's worth talking to your doctor to see if treatment with Olumiant is right for you.
Caption + Graphic: Olumiant Logo, “Please see the Indications and Safety Summary with Warnings on the website.”
**4:08**
Caption + Graphic: Olumiant Logo, “Olumiant is a registered trademark of Eli Lilly and Company, its subsidiaries, or affiliates. PP-BA-US-2145 10/2023 Lilly USA, LLC 2023. All rights reserved.”
## **“Despite the fact of embracing who I was, there wasn't a day that went by that I didn't wish for my hair back.”**
_\- Laura, actual patient with severe alopecia areata._
## **Select Safety Information**
**Olumiant may cause serious side effects, including:**
**Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
## See results from Olumiant's clinical trial.
[**Learn More**](https://olumiant.lilly.com/alopecia-areata/olumiant-results)
**Does Laura’s Story sound like yours?**
Ask your doctor to see if Olumiant might be right for you.
## **Spotlight on Laura’s Olumiant Experience**
“Once Olumiant was FDA approved for the treatment of severe alopecia areata in adults, I sought out a referral from my primary doctor to see a dermatologist. I read all I could to understand the potential risks and benefits.
I actually found out that I was going to be her first patient with alopecia areata that she would be treating with Olumiant. So I was very excited that we could learn together, and we could see the possibilities of what Olumiant could do for me.”
_\- Laura, actual patient with severe alopecia areata._
_Laura was compensated for her time. Individual results may vary._
Taking Olumiant? Inspire others.
[Share your story](https://www.lilly.com/your-story-matters)
## **Select Safety Information**
**Olumiant may cause serious side effects, including:**
**Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant for Alopecia Areata
[Skip to main content](https://olumiant.lilly.com/alopecia-areata/taking-olumiant#maincontent)
Olumiant is a prescription medication that is a Janus kinase (JAK) inhibitor, and is used to treat adults with severe alopecia areata.
## **Taking Olumiant**
Take Olumiant exactly as your doctor says.
Take Olumiant once a day by mouth with or without food.
Talk to your doctor if you cannot swallow tablets whole.
If you take too much Olumiant, call your doctor or poison control center at [1-800-222-1222](tel:1-800-222-1222), or go to the nearest hospital emergency room right away.
[**See Dosing & Side Effects**\\
Right](https://olumiant.lilly.com/dosing-side-effects)
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Understanding Alopecia Areata
[Skip to main content](https://olumiant.lilly.com/alopecia-areata/what-is-alopecia-areata#maincontent)
# **What is alopecia areata?**
Alopecia areata is a common autoimmune hair loss disorder. It affects people of all age groups and ethnicities.
The disease is unpredictable and can initially present as small, well-defined patches of hair loss on the scalp, to complete loss of scalp and body hair.
While the causes of alopecia areata are not fully understood, it is believed to be the result of complex immune signals that change the hair growth cycle, resulting in hair loss.
## **Is there more to alopecia areata than the hair loss you see?**
Alopecia areata is an autoimmune disease. It is triggered by complex signals from the immune system that change the normal hair growth cycle, resulting in hair loss.
**Connect with a community that understands**
We’ve partnered with the National Alopecia Areata Foundation to help you discover insights, understanding, and inspiration from a group of people who know what you’re going through.
[**Connect With NAAF**\\
Right](https://www.naaf.org/)
Want to know more about Olumiant and whether it may be able to help you?
[**Discover Olumiant Results**\\
Right](https://olumiant.lilly.com/alopecia-areata/olumiant-results)
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](http://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](http://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant for Alopecia Areata
[Skip to main content](https://olumiant.lilly.com/hcp/alopecia-areata#maincontent)
[**Explore Efficacy Results at 36 Weeks**](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy)
### The number of Olumiant prescribers in Dermatology continues to grow
### Since FDA approval for severe AA\*
**12,000+**
**patients with severe AA**
**5,000+**
**prescribers**
**22+ months**
**of real-world experience**
Laura, an actual Olumiant patient, individual results may vary
[Watch Laura's Olumiant Story](https://olumiant.lilly.com/alopecia-areata/patient-stories#laura-patient-story)
Laura was compensated for her time
\*Data cutoff date was July 2024.
[**Patient Profile for Olumiant**\\
Right](https://olumiant.lilly.com/hcp/alopecia-areata/patient-profile)
[**Explore Olumiant’s Efficacy**\\
Right](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy)
[**See Olumiant’s Safety**\\
Right](https://olumiant.lilly.com/hcp/alopecia-areata/safety)
[**Get Your Patients Started**\\
Right](https://olumiant.lilly.com/hcp/alopecia-areata/getting-patients-started)
**INDICATION**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata (AA).
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.
**SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**_SERIOUS INFECTIONS:_ Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.**
**_MORTALITY:_ Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase inhibitor (JAK) vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.**
**_MALIGNANCIES:_ Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE):_ Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_THROMBOSIS:_ Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.**
**References:**
1. Olumiant. Prescribing Information. Lilly USA, LLC.
2. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. _N Engl J Med._ 2022;386:1687-1699. doi:10.1056/NEJM oa 2110343.
3. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. _N Engl J Med._ 2022;386(suppl):1-76.
4. Data on file. Lilly USA, LLC. DOF-BA-US-0110.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant for COVID-19
[Skip to main content](https://olumiant.lilly.com/hcp/covid-19#maincontent)
# About Olumiant for COVID-19
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).1
ECMO=extracorporeal membrane oxygenation; JAK=Janus kinase.
[Explore Efficacy](https://olumiant.lilly.com/hcp/covid-19/efficacy)
## Timeline
### Timeline of Olumiant for COVID-19
\*Information on the baricitinib EUA can be found on [baricitinibemergencyuse.com](http://www.baricitinibemergencyuse.com/)
AI=Artificial Intelligence; ECMO=extracorporeal membrane oxygenation; EUA=Emergency Use Authorization; FDA=Food and Drug Administration; NIAID=National Institute of Allergy and Infectious Diseases.
Up
Image Description
Displayed is the timeline of Olumiant for COVID-19. On **February 3, 2020**, an artificial intelligence platform identifies baricitinib as a potential intervention for COVID-19. On **May 8, 2020**, the ACTT-2 study of remdesivir with or without baricitinib in certain hospitalized COVID-19 patients begins, in collaboration with the National Institute of Allergy and Infectious Diseases. On **June 12, 2020**, the COV-BARRIER study of baricitinib and background therapy in certain hospitalized COVID-19 patients begins. Five months later, on **November 19, 2020**, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for baricitinib with remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The following month on **December 23, 2020**, the COV-BARRIER OS7 Addendum study of baricitinib and background therapy of adults with COVID-19 requiring invasive mechanical ventilation or ECMO begins. Seven months later, on **July 28, 2021**, the FDA revised the EUA for baricitinib for the treatment of COVID-19 in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. And then on **May 10, 2022**, the FDA approved Olumiant (baricitinib) for the treatment of hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. In addition, the FDA has revised the baricitinib EUA. Information on the baricitinib EUA can be found on [baricitinibemergencyuse.com](http://www.baricitinibemergencyuse.com/).
## Patient Profile
### Olumiant: A Treatment Option for Certain Hospitalized Adults With COVID-19
Meet James — a 58-year-old man hospitalized with confirmed COVID-19.
Clinical Factors:
- Requires supplemental oxygen
- Receiving local standard of care
Consider adding Olumiant to his treatment regimen.
Hypothetical patient profile.
**SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**_SERIOUS INFECTIONS:_ Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.**
**_MORTALITY:_ Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.**
**_MALIGNANCIES:_ Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE):_ Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_THROMBOSIS:_ Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.**
## How does Olumiant work?1
### Olumiant Mechanism of Action
- Within the intracellular signaling pathway, JAKs phosphorylate and activate STATs, which modulate gene expression within the cell.
- Olumiant modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs.
- Within in vitro assays, Olumiant has greater inhibitory potency at JAK1, JAK2 and TYK2, relative to JAK3.
The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.
JAK=Janus kinase; STAT=signal transducer and activator of transcription; TYK=tyrosine kinase.
**References**
1. Olumiant. Prescribing information. Lilly USA, LLC.
2. Richardson P, Griffin I, Tucker C, et al. Baricitinib as potential treatment for 2019-nCoV acute respiratory disease. _Lancet._ 2020;395(10223):e3 0-e31.
3. National Institute of Allergy and Infectious Diseases (NIAID). A multicenter, adaptive, randomized blinded controlled trial of the safety and efficacy of investigational therapeutics for the treatment of Covid-19 in hospitalized adults (ACTT-2). Clinicaltrials.gov identifier: NCT04401579. Updated April 26, 2021. Accessed January 25, 2022.
[https://www.clinicaltrials.gov/ct2/show/study/NCT04401579?term=ACTT2&draw=2](https://www.clinicaltrials.gov/ct2/show/study/NCT04401579?term=ACTT2&draw=2)
4. A randomized, double-blind, placebo-controlled, parallel-group phase 3 study of baricitinib in patients with Covid-19 Infection. ClinicalTrials.gov identifier: NCT04421027. Updated July 19, 2021. Accessed January 25, 2022.
[https://clinicaltrials.gov/ct2/show/NCT04421027](https://clinicaltrials.gov/ct2/show/NCT04421027)
5. US Food and Drug Administration. Baricitinib EUA Letter of Authorization. Accessed May 9, 2022.
[https://www.fda.gov/media/143822/download](https://www.fda.gov/media/143822/download)
6. Ely EW, Ramanan AV, Kartman CE, et al. Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hopsitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial. _Lancet Respir Med._ Published online February 3, 2022. doi: https://doi.org/10.1016/S2213-2600(22)00006-6.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant for Rheumatoid Arthritis
[Skip to main content](https://olumiant.lilly.com/hcp/rheumatoid-arthritis#maincontent)
# Rheumatoid Arthritis Efficacy
## A trial designed for patients still in need1,2
### BEACON (Study RA-4) was one of four phase 3 clinical trials evaluating the efficacy of Olumiant across the RA treatment algorithm1,2
Up
Image Description
Olumiant was evaluated in a 24-week, randomized, double-blind, placebo-controlled trial in 527 patients with moderately to severely active RA who had an inadequate response or intolerance to at least 1 TNF inhibitor. Patients received Olumiant 2 mg (n=174) or baricitinib 4 mg (n=177) once daily or placebo (n=176), added to stable background cDMARD treatment.
Olumiant was evaluated in a 24-week randomized, double-blind, phase 3, placebo-controlled trial in 527 patients with moderately to severely active RA who had an inadequate response or intolerance to one or more TNF inhibitors; the patients could have had prior therapy with other biologic DMARDs.\* The patients in this study were on stable background cDMARDs.
From week 16, non-responding patients could be rescued to a higher dose (baricitinib 4 mg/day). Baricitinib 4 mg is not an approved dose for RA.
**Primary endpoint**
- Proportion of patients achieving ACR20 response at week 12 with Olumiant 4 mg + cDMARDs which is not an approved dose in RA.
**Select inclusion criteria**
- Inadequate response or intolerance to ≥1 TNFi. The patients in the study could have had prior therapy with other biologic DMARDs
- Stable background cDMARDs
**Secondary measures included**
- ACR50 and ACR70
- DAS28-CRP
- HAQ-DI
\* Biologic DMARDs included TNF inhibitors (etanercept, adalimumab, infliximab, golimumab, certolizumab), non-TNF inhibitors (abatacept, tocilizumab, rituximab, anakinra), and non-approved agents.
* * *
In the overall patient population that had previously been treated with TNF inhibitors
40% were treated with ≥2 TNF inhibitors
In the overall patient population that had previously been treated with bDMARDs
57% were treated with ≥2 bDMARDs
* * *
RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; DMARD=disease-modifying antirheumatic drug; cDMARD=conventional disease-modifying antirheumatic drug; ACR20/50/70=American College of Rheumatology 20%/50%/70% improvement criteria; DAS28-CRP=Disease Activity Score 28–C-reactive protein; HAQ-DI=Health Assessment Questionnaire-Disability Index.
## Patient characteristics and disease activity in the BEACON trial (Study RA-4)2,4,5
| | Placebo + cDMARDs (n=176) | Olumiant 2 mg + cDMARDs (n=174) |
| --- | --- | --- |
| Mean (SD) age, years | Placebo + cDMARDs (n=176):
56 (11) | Olumiant 2 mg + cDMARDs (n=174):
55 (11) |
| Female | Placebo + cDMARDs (n=176):
145 (82) | Olumiant 2 mg + cDMARDs (n=174):
137 (79) |
| Mean (SD) duration of RA, years | Placebo + cDMARDs (n=176):
14 (10) | Olumiant 2 mg + cDMARDs (n=174):
14 (8) |
| ACPA positive | Placebo + cDMARDs (n=176):
125 (71) | Olumiant 2 mg + cDMARDs (n=174):
124 (71) |
| RF positive | Placebo + cDMARDs (n=176):
130 (74) | Olumiant 2 mg + cDMARDs (n=174):
128 (74) |
| No. of prior TNFi: 1 | Placebo + cDMARDs (n=176):
104 (59) | Olumiant 2 mg + cDMARDs (n=174):
102 (59) |
| No. of prior TNFi: 2 | Placebo + cDMARDs (n=176):
50 (28) | Olumiant 2 mg + cDMARDs (n=174):
60 (35) |
| No. of prior TNFi: ≥3 | Placebo + cDMARDs (n=176):
19 (11) | Olumiant 2 mg + cDMARDs (n=174):
12 (7) |
| No. of prior non-TNFi: 1 | Placebo + cDMARDs (n=176):
37 (21) | Olumiant 2 mg + cDMARDs (n=174):
45 (26) |
| No. of prior non-TNFi: 2 | Placebo + cDMARDs (n=176):
15 (9) | Olumiant 2 mg + cDMARDs (n=174):
14 (8) |
| No. of prior non-TNFi: ≥3 | Placebo + cDMARDs (n=176):
10 (6) | Olumiant 2 mg + cDMARDs (n=174):
11 (6) |
| No. of prior bDMARDs: 1 | Placebo + cDMARDs (n=176):
81 (46) | Olumiant 2 mg + cDMARDs (n=174):
69 (40) |
| No. of prior bDMARDs: 2 | Placebo + cDMARDs (n=176):
47 (27) | Olumiant 2 mg + cDMARDs (n=174):
55 (32) |
| No. of prior bDMARDs: ≥3 | Placebo + cDMARDs (n=176):
47 (27) | Olumiant 2 mg + cDMARDs (n=174):
50 (29) |
| No. of concomitant cDMARDS: 1 | Placebo + cDMARDs (n=176):
160 (91) | Olumiant 2 mg + cDMARDs (n=174):
156 (90) |
| No. of concomitant cDMARDS: ≥2 | Placebo + cDMARDs (n=176):
16 (9) | Olumiant 2 mg + cDMARDs (n=174):
17 (10) |
| Concomitant MTX use | Placebo + cDMARDs (n=176):
143 (81) | Olumiant 2 mg + cDMARDs (n=174):
141 (81) |
| Mean (SD) MTX dose, mg/week | Placebo + cDMARDs (n=176):
16 (5) | Olumiant 2 mg + cDMARDs (n=174):
16 (5) |
| Concomitant corticosteroid use | Placebo + cDMARDs (n=176):
116 (66) | Olumiant 2 mg + cDMARDs (n=174):
92 (53) |
Data displayed are n (%) unless otherwise noted.
959 patients were screened to randomize 527 patients in the following regions: US and Canada (44%), Europe (30%), Central and South America (10%), Asia (6%), and Rest of World (10%).
| | Placebo + cDMARDs (n=176) | Olumiant 2 mg + cDMARDs (n=174) |
| --- | --- | --- |
| Swollen joint count (SJC), of 66 | Placebo + cDMARDs (n=176):
17 (11) | Olumiant 2 mg + cDMARDs (n=174):
19 (12) |
| Tender joint count (TJC), of 68 | Placebo + cDMARDs (n=176):
28 (16) | Olumiant 2 mg + cDMARDs (n=174):
31 (16) |
| Physician Global Assessment† | Placebo + cDMARDs (n=176):
67 (19) | Olumiant 2 mg + cDMARDs (n=174):
67 (17) |
| Patient Global Assessment† | Placebo + cDMARDs (n=176):
66 (19) | Olumiant 2 mg + cDMARDs (n=174):
67 (19) |
| Pain† | Placebo + cDMARDs (n=176):
65 (19) | Olumiant 2 mg + cDMARDs (n=174):
62 (22) |
| HAQ-DI‡ | Placebo + cDMARDs (n=176):
1.78 (0.57) | Olumiant 2 mg + cDMARDs (n=174):
1.71 (0.55) |
| hsCRP, mg/L§ | Placebo + cDMARDs (n=176):
21 (25) | Olumiant 2 mg + cDMARDs (n=174):
20 (22) |
| ESR, mm/hr | Placebo + cDMARDs (n=176):
47 (24) | Olumiant 2 mg + cDMARDs (n=174):
45 (24) |
| DAS28-CRP | Placebo + cDMARDs (n=176):
5.9 (0.9) | Olumiant 2 mg + cDMARDs (n=174):
6.0 (0.9) |
Data displayed are mean (standard deviation).
†Scores for the physician global assessment, patient global assessment, and pain range from 0 to 100 mm on a visual analog scale (VAS), with higher scores indicating greater levels of reported disease activity or pain.
‡Scores on the HAQ-DI range from 0 to 3, with higher scores indicating greater disability.
§The upper limit of normal range (ULN) for the hsCRP level is 3 mg/L.
SD=standard deviation; ACPA=anti-citrullinated peptide/protein antibody; RF=rheumatoid factor; bDMARD=biologic disease-modifying antirheumatic drug; MTX=methotrexate; hsCRP=high-sensitivity C-reactive protein; ESR = erythrocyte sedimentation rate; DAS28 = Disease Activity Score modified to include the 28-joint count; HAQ-DI = Health Assessment Questionnaire-Disability Index; ULN=upper limit of normal; ESR = Erythrocyte sedimentation rate; DAS28-CRP=Disease Activity Score 28–C-reactive protein.
BEACON (RA-4) ACR20/50/70 response rates
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BEACON (RA-4) ACR20/50/70 response rates
BEACON (RA-4) ACR20 by treatment history
BEACON (RA-4) ACR20 over time
BEACON (RA-4) ACR components over time
Reach for results
## Olumiant reduced the signs and symptoms of RA1-3
### TNFi-IR patients receiving Olumiant demonstrated higher ACR response rates vs placebo at weeks 12 and 24
Statistical significance declared without control for multiple comparisons in the hierarchical testing.
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Image Description
The American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70) response rates at weeks 12 and 24 are presented as bar graphs.
In the following results, patients taking Olumiant 2 milligrams (mg)/day plus conventional disease-modifying antirheumatic drugs (cDMARDs) (n=174) were compared to patients taking placebo plus cDMARDs (n=176).
At week 12, 49% of patients taking Olumiant 2 mg/day plus cDMARDs achieved an ACR20 response compared to 27% of patients taking placebo plus cDMARDs, with a p-value of ≤0.001. At week 12, 20% of patients taking Olumiant 2 mg/day plus cDMARDs achieved an ACR50 response compared to 8% of patients taking placebo plus cDMARDs, with a p-value of ≤0.01. At week 12, 13% of patients taking Olumiant 2 mg/day plus cDMARDs achieved an ACR70 response compared to 2% of patients taking placebo plus cDMARDs, with a p-value of ≤0.001.
At week 24, 45% of patients taking Olumiant 2 mg/day plus cDMARDs achieved an ACR20 response compared to 27% of patients taking placebo plus cDMARDs, with a p-value of ≤0.001. At week 24, 23% of patients taking Olumiant 2 mg/day plus cDMARDs achieved an ACR50 response compared to 13% of patients taking placebo plus cDMARDs, with a p-value of ≤0.05. At week 24, 13% of patients taking Olumiant 2 mg/day plus cDMARDs achieved an ACR70 response compared to 3% of patients taking placebo plus cDMARDs, with a p-value of ≤0.001.
From week 16, non-responding patients could be rescued to a higher dose which is not approved for RA. Patients who were rescued or discontinued treatment were considered non-responders in the analysis.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12 with Olumiant 4mg which is not approved for RA.
[See RA-BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
**SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**_SERIOUS INFECTIONS:_ Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.**
**_MORTALITY:_ Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.**
**_MALIGNANCIES:_ Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE):_ Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_THROMBOSIS:_ Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.**
## ACR20 Response Rates at Week 12 by Treatment History1-3
Statistical significance declared without control for multiple comparisons in the hierarchical testing.
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Image Description
The American College of Rheumatology 20% improvement criteria (ACR20) response rates at week 12 by treatment history are presented as bar graphs.
In all patients (N=350), the percentage of patients with ACR20 response rates at week 12 in patients taking Olumiant 2 mg +cDMARDS (n=174) was 49% compared to 27% of patients taking placebo +cDMARDs (n=176). The p-value was ≤0.001.
In patients who had a treatment history of <3 biologic disease-modifying antirheumatic drug (bDMARDs) (n=253), the percentage of patients with ACR20 response rates taking Olumiant 2 mg/day plus cDMARDs was 53% compared to 33% of patients taking placebo plus cDMARDs.
In patients who had a treatment history of ≥3 bDMARDs (n=97), the percentage of patients with ACR20 response rates taking Olumiant 2 mg/day plus cDMARDs was 38% compared to 13% of patients taking placebo plus cDMARDs.
In patients who had a treatment history of one tumor necrosis factor inhibitor (TNFi) (n=206), the percentage of patients with ACR20 response rates taking Olumiant 2 mg/day plus cDMARDs was 53% compared to 30% of patients taking placebo plus cDMARDs.
In patients who had a treatment history of ≥2 TNFis (n=141), the percentage of patients with ACR20 response rates taking Olumiant 2 mg/day plus cDMARDs was 43% compared to 25% of patients taking placebo plus cDMARDs.
Patients who discontinued treatment were considered non-responders in the analysis.
The subgroup data presented were from prespecified (patients by number of prior bDMARDs) or post hoc analysis (patients by number of prior TNFis), but were not type I error controlled. Therefore, treatment differences between Olumiant and placebo for the subgroup analysis cannot be regarded as statistically significant.
Inclusion criteria for the BEACON study (Study RA-4) required inadequate response or intolerance to ≥1 TNFi.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12 with Olumiant 4 mg + cDMARDs which is not an approved dose for RA.
**Prior treatment experience in BEACON**
- 40% of the patients taking Olumiant 2 mg + cDMARDs or placebo + cDMARDs in the study had prior treatment experience with ≥2 TNFis
- 28% of patients taking Olumiant 2 mg + cDMARDs or placebo + cDMARDs in the study had prior treatment experience with ≥3 bDMARDs
[See RA-BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
## Reach for results starting at week 11,2
### Olumiant demonstrated rapid improvement, with ACR20 responses seen as early as week 1 in TNFi-IR patients
Statistical significance declared without control for multiple comparisons in the hierarchical testing.
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Image Description
A line graph is shown for ACR20 response rates in the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174). In the figure, the Y-axis indicates the percentage of patients who had an ACR20 response, and the X-axis indicates the timepoint in weeks. Data points on the placebo plus cDMARD line include 0% at week 0, 7% at week 1, 17% at week 2, 26% at week 4, 27% at week 8, 27% at week 12, 27% at week 14, 26% at week 16, 28% at week 20, and 27% at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0% at week 0, 19% at week 1, 29% at week 2, 39% at week 4, 47% at week 8, 49% at week 12, 49% at week 14, 52% at week 16, 49% at week 20, and 45% at week 24. Nominal p-values are shown at weeks 1, 2, 4, 8, 14, 16, and 20. A p-value of less than or equal to 0.001 is shown at weeks 12 and 24.
From week 16, non-responding patients could be rescued to a higher dose which is not approved for RA. Patients who were rescued or discontinued treatment were considered non-responders in the analysis.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12 with Olumiant 4mg which is not approved for RA.
[See RA-BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
## Efficacy across all ACR components1-3
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Image Description
**Pain, VAS 0-100**
A line graph representing a change from baseline in pain VAS from 0-100 in the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174) over 24 weeks with LS mean change from baseline on the Y axis and weeks on the X axis. Data points on the placebo plus cDMARD line include 0 at week 0, -5 at week 1, -6.7 at week 2, -9.2 at week 4, -9 at week 8, -8.8 at week 12, -10.2 at week 14, -8.1 at week 16, -8.9 at week 20, and -8.8 at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0 at week 0, -7.2 at week 1, -10.5 at week 2, -14.4 (nominal p-value) at week 4, -17.8 (nominal p-value) at week 8, -17.1 (nominal p-value) at week 12, -18.2 (nominal p-value) at week 14, -18 (nominal p-value) at week 16, -18.9 (nominal p-value) at week 20, -18.8 (nominal p-value) at week 24.
Baseline values were 65 for placebo plus cDMARDs and 62 for Olumiant 2 mg/day plus cDMARDs.
**HAQ-DI, 0-3**
A line graph representing a change from baseline in HAQ-DI from 0 to 3 in the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174) over 24 weeks with LS mean change from baseline on the Y axis and weeks on the X axis. Data points on the placebo plus cDMARD line include 0 at week 0, -0.09 at week 1, -0.16 at week 2, -0.18 at week 4, -0.21 at week 8, -0.17 at week 12, -0.17 at week 14, -0.17 at week 16, -0.16 at week 20, and -0.15 at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0 at week 0, -0.18 (nominal p-value) at week 1, -0.21 at week 2, -0.3 (nominal p-value) at week 4, -0.36 (nominal p-value) at week 8, -0.37 (nominal p-value) at week 12, -0.38 (nominal p-value) at week 14, -0.42 (nominal p-value) at week 16, -0.4 (nominal p-value) at week 20, -0.37 (p-value less than or equal to 0.001) at week 24.
Baseline values were 1.78 for placebo plus cDMARDs and 1.71 for Olumiant 2 mg/day plus cDMARDs.
**Patient Global, VAS 0-100**
A line graph representing a change from baseline in patient global VAS from 0-100 in the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174) over 24 weeks with LS mean change from baseline on the Y axis and weeks on the X axis. Data points on the placebo plus cDMARD line include 0 at week 0, -5 at week 1, -6.4 at week 2, -9.3 at week 4, -11.9 at week 8, -8.9 at week 12, -10 at week 14, -7.9 at week 16, -9.8 at week 20, and -8.8 at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0 at week 0, -8.7 (nominal p-value) at week 1, -12.1 (nominal p-value) at week 2, -17.9 (nominal p-value) at week 4, -21.3 (nominal p-value) at week 8, -20.4 (nominal p-value) at week 12, -20.7 (nominal p-value) at week 14, -21.5 (nominal p-value) at week 16, -21.1 (nominal p-value) at week 20, -20.3 (nominal p-value) at week 24.
Baseline values were 66 for placebo plus cDMARDs and 67 for Olumiant 2 mg/day plus cDMARDs.
**TJC, 0-68**
A line graph representing a change from baseline in tender joint count from 0 to 68 in the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174) over 24 weeks with LS mean change from baseline on the Y axis and weeks on the X axis. Data points on the placebo plus cDMARD line include 0 at week 0, -2.7 at week 1, -5.7 at week 2, -6.5 at week 4, -8.2 at week 8, -8.7 at week 12, -8 at week 14, -6.6 at week 16, -7.8 at week 20, and -8.4 at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0 at week 0, -3.7 at week 1, -6.1 at week 2, -8.2 at week 4, -10.1 at week 8, -11.6 (nominal p-value) at week 12, -11.2 (nominal p-value) at week 14, -10 (nominal p-value) at week 16, -10.5 at week 20, -10 at week 24.
Baseline values were 28 for placebo plus cDMARDs and 31 for Olumiant 2 mg/day plus cDMARDs.
**SJC, 0-68**
A line graph representing a change from baseline in swollen joint count from 0 to 66 in the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174) over 24 weeks with LS mean change from baseline on the Y axis and weeks on the X axis. Data points on the placebo plus cDMARD line include 0 at week 0, -0.8 at week 1, -3.6 at week 2, -4.3 at week 4, -5 at week 8, -5.1 at week 12, -4.8 at week 14, -3.3 at week 16, -4.3 at week 20, and -4.8 at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0 at week 0, -2.6 (nominal p-value) at week 1, -4.2 at week 2, -5.3 at week 4, -6.5 at week 8, -7.3 (nominal p-value) at week 12, -6.6 (nominal p-value) at week 14, -5.7 (nominal p-value) at week 16, -6.2 (nominal p-value) at week 20, -6.2 at week 24.
Baseline values were 17 for placebo plus cDMARDs and 19 for Olumiant 2 mg/day plus cDMARDs.
**Physician Global, VAS 0-100**
A line graph representing a change from baseline in physician global VAS from 0 to 100 in the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174) over 24 weeks with LS mean change from baseline on the Y axis and weeks on the X axis. Data points on the placebo plus cDMARD line include 0 at week 0, -9 at week 1, -12.7 at week 2, -19 at week 4, -19.8 at week 8, -17.2 at week 12, -15.9 at week 14, -14.8 at week 16, -17.8 at week 20, and -19.8 at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0 at week 0, -12.3 at week 1, -17.4 (nominal p-value) at week 2, -24.2 (nominal p-value) at week 4, -28.8 (nominal p-value) at week 8, -30.6 (nominal p-value) at week 12, -30 (nominal p-value) at week 14, -26.3 (nominal p-value) at week 16, -28.6 (nominal p-value) at week 20, -29.1 (nominal p-value) at week 24.
Baseline values were 67 for placebo plus cDMARDs and 67 for Olumiant 2 mg/day plus cDMARDs.
**hsCRP, mg/L**
A line graph representing a change from baseline in hsCRP milligrams per liter in the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174) over 24 weeks with LS mean change from baseline on the Y axis and weeks on the X axis. Data points on the placebo plus cDMARD line include 0 at week 0, 0.57 at week 1, -0.82 at week 2, -1.35 at week 4, 0.24 at week 8, 1.07 at week 12, 1.76 at week 14, 4.17 at week 16, 4.48 at week 20, and 3.62 at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0 at week 0, -8.13 (nominal p-value) at week 1, -6.85 (nominal p-value) at week 2, -7.38 (nominal p-value) at week 4, -6.19 (nominal p-value) at week 8, -5.24 (nominal p-value) at week 12, -5.64 (nominal p-value) at week 14, -6.3 (nominal p-value) at week 16, -3.84 (nominal p-value) at week 20, -4.64 (nominal p-value) at week 24.
Baseline values were 20.6 for placebo plus cDMARDs and 19.9 for Olumiant 2 mg/day plus cDMARDs.
Statistical significance declared without control for multiple comparisons in the hierarchical testing.
Baseline values are mean.
From week 16, non-responding patients could be rescued to a higher dose, which is not approved for RA. Missing data were reported as mLOCF for all measures except HAQ-DI at week 12, which used mBOCF.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12.
LS=least squares; VAS=visual analog scale: 0=best, 100=worst; TJC=total joint count; SJC=swollen joint count; mLOCF=modified last observation carried forward; mBOCF=modified baseline observation carried forward.
[See BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
BEACON (RA-4) Pain improvement at weeks 1, 12, and 24
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BEACON (RA-4) Pain improvement at weeks 1, 12, and 24
BEACON (RA-4) Pain improvement by treatment history
Results TNFi-IR patients can feel
## Pain improvement at weeks 1, 12, and 241,2
### Percentage of TNF-IR patients achieving ≥30%, ≥50%, and ≥70% reduction in pain from baseline
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Image Description
The percentages of patients with pain improvement ≥30%, ≥50%, and ≥70% at weeks 1, 12, and 24 are presented as bar graphs.
In the following results, patients taking Olumiant 2 milligrams (mg)/day plus conventional disease-modifying antirheumatic drugs (cDMARDs) (n=174) were compared to patients taking placebo plus cDMARDs (n=176).
At week 1, the percentage of patients with ≥30% pain improvement was 25% for the Olumiant 2 mg/day plus cDMARDs arm compared to 20% in the placebo plus cDMARDs arm. At week 1, the percentage of patients with ≥50% pain improvement was 9% for the Olumiant 2 mg/day plus cDMARDs arm compared to 6% in the placebo plus cDMARDs arm. At week 1, the percentage of patients with ≥70% pain improvement was 3% for the Olumiant 2 mg/day plus cDMARDs arm compared to 2% in the placebo plus cDMARDs arm.
At week 12, the percentage of patients with ≥30% pain improvement was 43% for the Olumiant 2 mg/day plus cDMARDs arm compared to 31% in the placebo plus cDMARDs arm. At week 12, the percentage of patients with ≥50% pain improvement was 31% for the Olumiant 2 mg/day plus cDMARDs arm compared to 17% in the placebo plus cDMARDs arm. At week 12, the percentage of patients with ≥70% pain improvement was 19% for the Olumiant 2 mg/day plus cDMARDs arm compared to 7% in the placebo plus cDMARDs arm.
At week 24, the percentage of patients with ≥30% pain improvement was 44% for the Olumiant 2 mg/day plus cDMARDs arm compared to 34% in the placebo plus cDMARDs arm. At week 24, the percentage of patients with ≥50% pain improvement was 32% for the Olumiant 2 mg/day plus cDMARDs arm compared to 20% in the placebo plus cDMARDs arm. At week 24, the percentage of patients with ≥70% pain improvement was 22% for the Olumiant 2 mg/day plus cDMARDs arm compared to 9% in the placebo plus cDMARDs arm.
From week 16, non-responding patients could be rescued to a higher dose which is not approved for RA.
Missing data for pain analyses, tender and swollen joint counts were reported as mLOCF.
The data presented were from a post hoc analysis of the ACR component pain (VAS, 0-100) and were not type I error controlled. Therefore treatment differences between Olumiant and placebo cannot be regarded as statistically significant.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12.
In BEACON (TNFi-IR) (Olumiant 2 mg/day n=174; placebo n=176), 49% of patients receiving Olumiant + cDMARDs achieved ACR20 response at week 12 vs 27% of patients receiving placebo + cDMARDs. Patients who discontinued treatment were considered non-responders in the analysis.
For number of tender joints (0-68), the mean for placebo + cDMARD patients was 28 at baseline and 20 at week 12 and for Olumiant 2 mg + cDMARD patients the mean was 31 at baseline and 19 at week 12.
For number of swollen joints (0-66), the mean for placebo + cDMARD patients was 17 at baseline and 12 at week 12 and for Olumiant 2 mg + cDMARD patients the mean was 19 at baseline and 10 at week 12.
For pain, the mean score (VAS, 0-100) for placebo + cDMARD patients was 65 at baseline and 55 at week 12 and for Olumiant 2 mg + cDMARD patients the mean score was 62 at baseline and 46 at week 12.
[See RA-BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO SERIOUS INFECTIONS**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant. Closely monitor patients for development of infections during and after Olumiant treatment. Interrupt Olumiant if the patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.
TNFi-IR=tumor necrosis factor inhibitor-inadequate response; mLOCF=modified last observation carried forward; cDMARD=conventional disease-modifying antirheumatic drug; ACR20=American College of Rheumatology 20% improvement criteria; VAS=visual analog scale;0=best, 100=worst.
## Pain improvement at week 12 by treatment history1,2
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The percentages of patients with pain improvement at week 12 by treatment history are presented as bar graphs.
In patients who had a treatment history of 1 tumor necrosis factor inhibitor (TNFi) (n=203), the percentage of patients with ≥30% pain improvement was 45% in the Olumiant 2 mg/day plus conventional disease-modifying antirheumatic drugs (cDMARDs) arm compared to 34% in the placebo plus cDMARDs arm. In patients who had a treatment history of >1 TNFi (n=137), the percentage of patients with ≥30% pain improvement was 41% in the Olumiant 2 mg/day plus cDMARDs arm compared to 29% in the placebo plus cDMARDs arm. In patients who had a treatment history of <3 biologic disease-modifying antirheumatic drugs (bDMARDs) (n=249), the percentage of patients with ≥30% pain improvement was 47% in the Olumiant 2 mg/day plus cDMARDs arm compared to 37% in the placebo plus cDMARDs arm. In patients who had a treatment history of ≥3 bDMARDs (n=94), the percentage of patients with ≥30% pain improvement was 34% in the Olumiant 2 mg/day plus cDMARDs arm compared to 16% in the placebo plus cDMARDs arm.
In patients who had a treatment history of 1 TNFi (n=203), the percentage of patients with ≥50% pain improvement was 32% in the Olumiant 2 mg/day plus cDMARDs arm compared to 21% in the placebo plus cDMARDs arm. In patients who had a treatment history of >1 TNFi (n=137), the percentage of patients with ≥50% pain improvement was 30% in the Olumiant 2 mg/day plus cDMARDs arm compared to 12% in the placebo plus cDMARDs arm. In patients who had a treatment history of <3 bDMARDs (n=249), the percentage of patients with ≥50% pain improvement was 36% in the Olumiant 2 mg/day plus cDMARDs arm compared to 21% in the placebo plus cDMARDs arm. In patients who had a treatment history of ≥3 bDMARDs (n=94), the percentage of patients with ≥50% pain improvement was 20% in the Olumiant 2 mg/day plus cDMARDs arm compared to 7% in the placebo plus cDMARDs arm.
In patients who had a treatment history of 1 TNFi (n=203), the percentage of patients with ≥70% pain improvement was 21% in the Olumiant 2 mg/day plus cDMARDs arm compared to 8% in the placebo plus cDMARDs arm. In patients who had a treatment history of >1 TNFi (n=137), the percentage of patients with ≥70% pain improvement was 16% in the Olumiant 2 mg/day plus cDMARDs arm compared to 6% in the placebo plus cDMARDs arm. In patients who had a treatment history of <3 bDMARDs (n=249), the percentage of patients with ≥70% pain improvement was 22% in the Olumiant 2 mg/day plus cDMARDs arm compared to 8% in the placebo plus cDMARDs arm. In patients who had a treatment history of ≥3 bDMARDs (n=94), the percentage of patients with ≥70% pain improvement was 10% in the Olumiant 2 mg/day plus cDMARDs arm compared to 5% in the placebo plus cDMARDs arm.
Missing data for pain analyses, tender and swollen joint counts were reported as mLOCF.
The data presented were from a post hoc analysis of the ACR component pain (VAS 0-100). The BEACON study was not powered for these subgroups analyses, nor were the analyses type I error controlled. Therefore, treatment differences between Olumiant and placebo, observed in these subgroups, cannot be regarded as statistically significant.
Inclusion criteria for the BEACON study required inadequate response or intolerance to ≥1 TNFi.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12 with Olumiant 4 mg + cDMARDs which is not an approved dose for RA.
In BEACON (TNFi-IR) (Olumiant 2 mg/day n=174; placebo n=176), 49% of patients receiving Olumiant + cDMARDs achieved ACR20 response at week 12 vs 27% of patients receiving placebo + cDMARDs. Patients who discontinued treatment were considered non-responders in the analysis.
For pain, the mean score (VAS, 0-100) for placebo + cDMARD patients was 65 at baseline and 55 at week 12 and for Olumiant 2 mg + cDMARD patients the mean score was 62 at baseline and 46 at week 12.
For number of tender joints (0-68), the mean for placebo + cDMARD patients was 28 at baseline and 20 at week 12 and for Olumiant 2 mg + cDMARD patients the mean was 31 at baseline and 19 at week 12.
For number of swollen joints (0-66), the mean for placebo + cDMARD patients was 17 at baseline and 12 at week 12 and for Olumiant 2 mg + cDMARD patients the mean was 19 at baseline and 10 at week 12.
[See RA-BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
BEACON (RA-4) HAQ-DI over time
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BEACON (RA-4) HAQ-DI over time
BEACON (RA-4) HAQDI MCIDs
## Improved physical function may be within reach with Olumiant1,2
### Differences in HAQ-DI improvement between Olumiant vs placebo were significant at week 24
Statistical significance declared without control for multiple comparisons in the hierarchical testing.
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Image Description
A line graph representing change in HAQ-DI in the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174) is shown. In the figure, the Y-axis represents the LS mean change from baseline in HAQ-DI score, and the X-axis represents the timepoint in weeks. Data points on the placebo plus cDMARD line include 0 at week 0, -0.09 at week 1, -0.16 at week 2, -0.18 at week 4, -0.21 at week 8, -0.17 at week 12, -0.17 at week 14, -0.17 at week 16, -0.16 at week 20, and -0.15 at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0 at week 0, -0.18 at week 1, -0.21 at week 2, -0.3 at week 4, -0.36 at week 8, -0.37 at week 12, -0.38 at week 14, -0.42 at week 16, -0.4 at week 20, and -0.37 at week 24. Nominal p-values are indicated at weeks 1, 4, 8, 12, 14, 16, and 20. A p-value ≤0.001 is indicated at week 24.
From week 16, non-responding patients could be rescued to a higher dose which is not approved for RA.
Missing data were reported as mLOCF except for week 12, which was reported as mBOCF.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12.
Mean baseline HAQ-DI was 1.71 for Olumiant 2 mg +cDMARDs and 1.78 for placebo +cDMARDs.
[See RA-BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO TUBERCULOSIS**
Evaluate patients for active infection prior to initiating Olumiant. Olumiant should not be given to patients with active TB. Test patients for latent TB and if positive, treat with standard antimycobacterial therapy before initiating Olumiant. Monitor patients for development of signs and symptoms of TB, including patients who tested negative for latent TB prior to initiating therapy.
HAQ-DI=Health Assessment Questionnaire-Disability Index; cDMARD=conventional disease-modifying antirheumatic drug; LS=least squares; ACR20=American College of Rheumatology 20% improvement criteria; mLOCF=modified last observation carried forward; mBOCF=modified baseline observation carried forward.
## Percentage of patients achieving MCID in HAQ-DI at weeks 12 and 241-3
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The percentage of patients achieving a minimally clinically important difference (MCID) in the Health Assessment Questionnaire-Disability Index (HAQ‐DI) score improvement of ≥0.22 or ≥0.3 at weeks 12 and 24 are presented as bar graphs.
In the following results, patients taking Olumiant 2 milligrams (mg)/day plus conventional disease-modifying antirheumatic drugs (cDMARDs) (n=174) were compared to patients taking placebo plus cDMARDs (n=176).
At week 12, the percentage of patients with a HAQ-DI MCID of ≥0.22 was 59% for the Olumiant 2 mg/day plus cDMARDs arm compared to 43% in the placebo plus cDMARDs arm. At week 12, the percentage of patients with a HAQ-DI MCID of ≥0.3 was 48% for the Olumiant 2 mg/day plus cDMARDs arm compared to 35% in the placebo plus cDMARDs arm.
At week 24, the percentage of patients with a HAQ-DI MCID of ≥0.22 was 50% for the Olumiant 2 mg/day plus cDMARDs arm compared to 30% in the placebo plus cDMARDs arm. At week 24, the percentage of patients with a HAQ-DI MCID of ≥0.3 was 41% for the Olumiant 2 mg/day plus cDMARDs arm compared to 24% in the placebo plus cDMARDs arm.
From week 16, non-responding patients could be rescued to a higher dose which is not approved for RA. Patients who were rescued or discontinued treatment were considered non-responders in the analysis.
The data presented were from a prespecified analysis, but were not type I error controlled. Therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12 with Olumiant 4 mg which is not approved for RA.
MCID=minimal clinically important difference; RA-rheumatoid arthritis; HAQ-DI=Health Assessment Questionnaire-Disability Index.
[See RA-BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
BEACON (RA-4) DAS28<2.6 and ≤3.2
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BEACON (RA-4) DAS28<2.6 and ≤3.2
BEACON (RA-4) DAS28-CRP over time
## Help TNFi-IR patients achieve low disease activity1,2
### Percentage of patients achieving DAS28 <2.6 and ≤3.2 at weeks 12 and 241,2
Statistical significance declared without control for multiple comparisons in the hierarchical testing.
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The percentages of patients with a Disease Activity Score-28 (DAS28) of <2.6 and ≤3.2 at weeks 12 and 24 are presented as bar graphs.
In the following results, patients taking Olumiant 2 milligrams (mg)/day plus conventional disease-modifying antirheumatic drugs (cDMARDs) (n=174) were compared to patients taking placebo plus cDMARDs (n=176).
At week 12, 11% of patients taking Olumiant 2 mg/day plus cDMARDs achieved a DAS28 score of <2.6 compared to 4% of patients taking placebo plus cDMARDs, with a p-value of ≤0.05. At week 12, the percentage of patients with a DAS28 score of ≤3.2 was 24% for the Olumiant 2 mg/day plus cDMARDs arm compared to 9% in the placebo plus cDMARDs arm.
At week 24, the percentage of patients with a DAS28 score of <2.6 was 11% for the Olumiant 2mg/day plus cDMARDs arm compared to 6% in the placebo plus cDMARDs arm. At week 24, the percentage of patients with a DAS28 score of ≤3.2 was 20% for the Olumiant 2 mg/day plus cDMARDs arm compared to 11% in the placebo plus cDMARDs arm.
From week 16, non-responding patients could be rescued to a higher dose, which is not approved for RA. Patients who were rescued or discontinued treatment were considered non-responders in the analysis.
DAS28 ≤3.2 presented were from a prespecified analysis, but were not type I error controlled. Therefore treatment differences between Olumiant and placebo cannot be regarded as statistically significant.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12.
[See RA-BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO VIRAL REACTIVATION**
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before starting therapy with Olumiant.
TNFi-IR=tumor necrosis factor inhibitor-inadequate response; DAS28=Disease Activity Score-28; cDMARD=conventional disease-modifying antirheumatic drug; ACR20=American College of Rheumatology 20% improvement criteria; RA=rheumatoid arthritis.
## Olumiant reduced disease activity as early as 1 week1
### Olumiant patients experienced changes in disease activity as early as week 1 and through week 241
Statistical significance declared without control for multiple comparisons in the hierarchical testing.
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Image Description
A line graph representing change in DAS28-CRP for the placebo plus cDMARD arm (n=176) and the Olumiant 2 mg/day plus cDMARD arm (n=174) is shown. In the figure, the Y-axis represents the least-squares mean change from baseline in DAS28-CRP, and the X-axis represents the timepoint in weeks. Data points on the placebo plus cDMARD line include 0 at week 0, -0.29 at week 1, -0.51 at week 2, -0.68 at week 4, -0.81 at week 8, -0.83 at week 12, -0.78 at week 14, -0.66 at week 16, -0.72 at week 20, and -0.79 at week 24. Data points on the Olumiant 2 mg/day plus cDMARD line include 0 at week 0, -0.61 at week 1, -0.89 at week 2, -1.16 at week 4, -1.41 at week 8, -1.49 at week 12, -1.48 at week 14, -1.4 at week 16, -1.41 at week 20, and -1.33 at week 24. Nominal p-values are indicated at weeks 1, 2, 4, 8, 12, 14, 16, 20, and 24.
Primary endpoint was the proportion in patients taking Olumiant 4 mg achieving ACR20 response at week 12 with Olumiant 4 mg which is not approved for RA.
From week 16, non-responding patients could be rescued to a higher dose, which is not approved for RA. Missing data were reported as mLOCF except for week 12, which was reported as mBOCF.
Mean baseline DAS28-CRP was 6.0 for Olumiant 2 mg and 5.9 for placebo.
[See RA-BEACON trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=beacon-study-design)
DAS28-CRP=Disease Activity Score 28–C-reactive protein; mLOCF=last observation carried forward; mBOCF=baseline observation carried forward
BUILD (RA-3) ACR20/50/70 response rates
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BUILD (RA-3) ACR20/50/70 response rates
BUILD (RA-3) ACR Components
BUILD (RA-3) DAS28-CRP
## ACR responses for Olumiant and placebo in cDMARD-IR patients1
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The American College of Rheumatology 20%/50%/70% improvement criteria (ACR20/50/70) response rates at weeks 12 and 24 are presented as bar graphs.
In the following results, patients taking Olumiant 2 milligrams (mg)/day plus conventional disease-modifying antirheumatic drugs (cDMARDs) (n=229) were compared to patients taking placebo plus cDMARDs (n=228).
At week 12, the percentage of patients with ACR20 response was 66% in the Olumiant 2 mg/day plus cDMARDs arm compared to 39% in the placebo plus cDMARDs arm. At week 12, percentage of patients with ACR50 response was 34% in the Olumiant 2 mg/day plus cDMARDs arm compared to 13% in the placebo plus cDMARDs arm. At week 12, the percentage of patients with ACR70 response was 18% in the Olumiant 2mg/day plus cDMARDs arm compared to 3% in the placebo plus cDMARDs arm.
At week 24, the percentage of patients with ACR20 response was 61% in the Olumiant 2 mg/day plus cDMARDs arm compared to 42% in the placebo plus cDMARDs arm. At week 24, percentage of patients with ACR50 response was 41% in the Olumiant 2 mg/day plus cDMARDs arm compared to 21% in the placebo plus cDMARDs arm. At week 24, the percentage of patients with ACR70 response was 25% in the Olumiant 2mg/day plus cDMARDs arm compared to 8% in the placebo plus cDMARDs arm.
**Olumiant is not indicated for cDMARD-IR patients.**
Patients who were rescued or discontinued treatment were considered non-responders in the analysis.
BUILD (Study RA-3) was a 24 -week trial in 684 patients with moderately to severely active RA who had an inadequate response or intolerance to cDMARDs. Patients received Olumiant 2 mg or baricitinib 4 mg once daily or placebo added to existing background cDMARD treatment. From week 16, non-responding patients could be rescued to receive baricitinib 4 mg once daily. Baricitinib 4 mg is not an approved dose for RA. Primary endpoint was the proportion of patients achieving ACR20 response at week 12.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO MORTALITY**
In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
cDMARD-IR=conventional disease-modifying antirheumatic drug-inadequate response.
## Components of ACR Response at week 121
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The components of the American College of Rheumatology (ACR) response at week 12 in conventional disease-modifying antirheumatic drug-inadequate response (cDMARD-IR) patients are presented as bar graphs.
In the following results, patients taking Olumiant 2 milligrams (mg)/day plus conventional disease-modifying antirheumatic drugs (cDMARDs) (n=229) were compared to patients taking placebo plus cDMARDs (n=228).
For the number of tender joints (0-68), the mean baseline number was 24 in the Olumiant 2 mg/day plus cDMARDs arm with a change from baseline of -13 and the mean baseline number was 24 in the placebo plus cDMARDs arm with a change from baseline of -9.
For the number of swollen joints (0-66), the mean baseline number was 14 in the Olumiant 2 mg/day plus cDMARDs arm with a change from baseline of -9 and the mean baseline number was 13 in the placebo plus cDMARDs arm with a change from baseline of -5.
For pain, the mean baseline score was 60 in the Olumiant 2 mg/day plus cDMARDs arm with a change from baseline of -26 and the mean baseline score was 57 in the placebo plus cDMARDs arm with a change from baseline of -14.
For patient global assessment, the mean baseline score was 62 in the Olumiant 2 mg/day plus cDMARDs arm with a change from baseline of -26 and the mean baseline score was 60 in the placebo plus cDMARDs arm with a change from baseline of -16.
For physician global assessment, the mean baseline score was 64 in the Olumiant 2 mg/day plus cDMARDs arm with a change from baseline of -31 and the mean baseline score was 62 in the placebo plus cDMARDs arm with a change from baseline of -21.
For Health Assessment Questionnaire-Disability Index (HAQ-DI), the mean baseline score was 1.51 in the Olumiant 2 mg/day plus cDMARDs arm with a change from baseline of -0.55 and the mean baseline score was 1.50 in the placebo plus cDMARDs arm with a change from baseline of -0.33.
For high-sensitivity C-reactive protein (hsCRP) (mg/L), the mean baseline number was 18.2 in the Olumiant 2 mg/day plus cDMARDs arm with a change from baseline of -9.6 and the mean baseline number was 17.7 in the placebo plus cDMARDs arm with a change from baseline of -0.5.
**Olumiant is not indicated for cDMARD-IR patients.**
A modified last observation carried forward (mLOCF) was used for missing data and patients who discontinued treatment.
Data shown are mean.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12 with Olumiant 4 mg which is not approved for RA.
aVisual analog scale: 0=best, 100=worst.
bHealth Assessment Questionnaire-Disability Index: 0=best, 3=worst; 20 questions; 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.
[See RA-BUILD trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=build-additional-data)
cDMARD-IR=conventional disease-modifying antirheumatic drug-inadequate response.
## Disease activity in cDMARD-IR patients1
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Image Description
The percentages of patients with a Disease Activity Score 28-C-reactive protein (DAS28-CRP) score of <2.6 at weeks 12 and 24 are presented as bar graphs.
In the following results, cDMARD patients taking taking Olumiant 2 milligrams (mg)/day plus conventional disease-modifying antirheumatic drugs (cDMARDs) (n=229) were compared to patients taking placebo plus cDMARDs (n=228).
At week 12, 26% of patients in the Olumiant 2 mg/day plus cDMARDs arm had a DAS28-CRP score of <2.6 compared to 9% in the placebo plus cDMARDs arm.
At week 24, 31% of patients in the Olumiant 2 mg/day plus cDMARDs arm had a DAS28-CRP score of <2.6 compared to 11% in the placebo plus cDMARDs arm.
**Olumiant is not indicated for cDMARD-IR patients.**
From week 16, non-responding patients could be rescued to a higher dose, which is not approved for RA. Patients who were rescued or discontinued treatment were considered non-responders in the analysis.
Primary endpoint was the proportion of patients achieving ACR20 response at week 12 with Olumiant 4 mg which is not an approved for RA.
[See BUILD trial design](https://olumiant.lilly.com/hcp/rheumatoid-arthritis?section=build-additional-data)
DAS28-CRP=Disease Activity Score 28–C-reactive protein.
**References**
1. Olumiant. Prescribing Information. Lilly USA, LLC. Eli Lilly and Company; 2022.
2. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. _N Engl J Med._ 2016;374:1243-1252.
3. Genovese MC, Kremer J, Kartman C, et al. Previous biologic disease-modifying antirheumatic drug exposure and efficacy and safety analysis from a phase 3 study of baricitinib in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitors. Poster presented at: ACR Annual; 2015; San Francisco, CA.
4. Smolen JS, Kremer JM, Gaich CL, et al. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). _Ann Rheum Dis._ 2017;0:1-7.
5. Genovese MC, Kremer J, Zamani O, et al. Baricitinib in patients with refractory rheumatoid arthritis. _N Engl J Med._ 2016;374(suppl):1-30.
6. Genovese MC, Kremer JM, Kartman CE, et al. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. _Rheumatology (Oxford)._ 2018;57:900-908.
7. Taylor P, Zhu B, Gaich C, et al. SAT0055 Baricitinib showed rapid and greater reduction in pain compared to adalimumab or placebo in patients with rheumatoid arthritis. _Ann Rheum Dis._ 2017;76:788.
8. Pope JE, Quebe A, Zhu B, et al. Assessment of pain relief with baricitinib by treatment history in patients with refractory rheumatoid arthritis \[abstract\]. _Arthritis Rheumatol._ 2018;70(suppl 10).
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNINGS:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
**MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
**MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
**MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
**THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
**HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
**GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
**LABORATORY ABNORMALITIES**
**_Neutropenia –_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia –_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia –_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations –_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations –_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
**VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
**ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
**PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
**HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant Savings Program
[Skip to main content](https://olumiant.lilly.com/hcp/support-resources#maincontent)
# Savings & Support
For eligible, commercially insured alopecia areata and rheumatoid arthritis patients
## Eligible, commercially insured patients can access Olumiant through the Olumiant Savings Card Program for as little as $5 or $25 per month\*
**\*Governmental beneficiaries excluded, terms and conditions apply. See terms and conditions below.**
## Terms and Conditions
By enrolling in the Olumiant Savings Card Program (“Program”) and using the Olumiant Savings Card (“Card”), you attest that you meet the eligibility criteria, agree to, and will comply with the terms and conditions described below:
**Card Eligibility:**
(1) You have been prescribed Olumiant® (baricitinib) for an approved use consistent with FDA-approved product labeling;
(2) You are enrolled in a commercial drug insurance plan;
**(3) You are not enrolled in any state, federal, or government funded healthcare program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state prescription drug assistance program;**
(4) You are a resident of the United States or Puerto Rico; and
(5) You are 18 years of age or older.
**Card Terms and Conditions:**
For patients with commercial drug insurance coverage for Olumiant: You must have commercial drug insurance that covers Olumiant and a prescription for an approved use consistent with FDA-approved product labeling to pay as little as $5 for a 1-month prescription fill of Olumiant. Month is defined as 30 days. Card must be first used by no later than 12/31/2025. Card savings are subject to a maximum monthly savings of wholesale acquisition cost plus usual and customary pharmacy charges and a separate maximum annual savings of up to $9,200 per calendar year. Card may be used for up to a maximum of 13 prescription fills per calendar year and up to a maximum of 24 prescription fills over the lifetime of the Program, subject to the previously stated maximum monthly and annual savings limit. Except where prohibited by applicable state law, Card monthly and annual savings are reduced if Lilly identifies that you are enrolled in a plan or program, sometimes called a maximizer plan, that adjusts your cost sharing amount to be equal to or include some portion of the savings provided by the Card and attempts to prevent the savings from this Card from being applied to your out-of-pocket costs, including but not limited to copayments, coinsurances, and deductibles (“Maximizer”). If the Program identifies you are enrolled in a Maximizer, Card savings are reduced to a maximum annual savings of up to $6,000 per calendar year. If you have reason to believe that the Program erroneously identified enrollment in a Maximizer, please call the Olumiant Savings Card Program at 1-844-658-6426. Participation in the Program requires a valid patient HIPAA authorization upon enrollment into the Program. Subject to Lilly USA, LLC's right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions which may occur at Lilly’s sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
For patients with commercial drug insurance who do not have coverage for Olumiant: You must have commercial drug insurance that does not cover Olumiant and a prescription for an approved use consistent with FDA-approved product labeling to pay as little as $25 for a 1-month supply of Olumiant. Month is defined as 30 days. Card must be first used by no later than 12/31/2025. Card savings are subject to a maximum monthly savings and a separate maximum annual savings. Card may be used for up to a maximum of 13 prescription fills per year and up to a maximum 24 prescription fills over the lifetime of the Program, subject to the maximum monthly and annual savings limit. Card must be first used by no later than 12/31/2025. Participation in the Program requires submission of a prior authorization (PA) prior to the first prescription fill. If coverage is denied, an appeal must be submitted prior to 5th month prescription fill. To remain eligible for the Program, a new PA, appeal, or medical exception must be submitted prior to the 13th prescription fill and as required by Lilly at its sole discretion. Participation in the Program requires a valid patient HIPAA authorization to remain in the Program. Subject to Lilly USA, LLC's right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions, which may occur at Lilly's sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
**Additional Program Terms and Conditions**
If you have an insurance plan that is participating in an alternate funding program (“AFP”) that requires you to apply to the Olumiant Savings Card Program or otherwise pursue specialty drug prescription coverage through an alternate funding vendor as a condition of, requirement for, or prerequisite to coverage of Olumiant, you are not eligible for and are prohibited from using the Olumiant Savings Card Program. AFPs include programs where coverage, reimbursement, or patient out of pocket costs for a product in some way vary based on the availability of a manufacturer co-pay program. AFPs may modify, delay, deny, restrict, or withhold insurance benefits or coverage from patients, or exclude Lilly products from coverage contingent upon a member's use of Olumiant Savings Card Program. You agree to inform Olumiant Savings Card Program if you are or become a member of such an alternative funding program. You are responsible for any applicable taxes, fees, and any amount that exceeds the applicable monthly or annual maximum Card savings. Monthly and annual maximum savings are set at Lilly's sole and absolute discretion and may be changed with or without notice at any time for any reason. At its sole discretion and with or without notice, Lilly may reduce, eliminate, or otherwise modify the Card savings for any reason, including but not limited to if your commercial drug insurance plan imposes additional requirements which limits or prevents you from receiving coverage for Olumiant, only allows partial coverage for Olumiant, removes coverage for Olumiant and requires you to utilize the Card, does not provide a material level of financial assistance for the cost of Olumiant, or does not apply Card payments to satisfy your co-payment, deductible, or coinsurance for Olumiant. Card savings are not valid for: Massachusetts residents if an AB-rated generic equivalent is available; California residents if an FDA-approved therapeutic equivalent is available. You must meet the Card eligibility criteria, terms and conditions every time you use the Card. If at any time you begin receiving drug coverage under any state, federal, or government funded healthcare program, you understand that you will no longer be eligible for the Olumiant Savings Card and agree to call the Olumiant Savings Card Program at 1-844-658-6426 to stop participation. Card activation is required. You may not seek reimbursement from your health insurance, any third party, or any health savings, flexible spending, or other healthcare reimbursement accounts, for any amount of the savings received through the Card. By utilizing the Card, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you will notify your Insurance Carrier of your redemption of the Card. Card savings cannot be combined or utilized with any other program, discount, discount card, cash discount card, coupon, incentive, or similar offer involving Olumiant. You agree that this Card savings is intended solely for the benefit of you, the patient, and that the Card benefits are nontransferable. It is prohibited for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade, or to counterfeit the Card. **THIS CARD IS NOT INSURANCE**. Lilly has the sole right to interpret and apply Card eligibility criteria, and terms and conditions. Card eligibility, and terms and conditions may be terminated, rescinded, revoked, or amended by Lilly at any time without notice and for any reason. Lilly's sole discretion to terminate, rescind, revoke, or amend Card eligibility and/or Card terms and conditions includes the right to terminate any individual Card if Lilly determines, in its sole discretion, that a patient does not satisfy the Card's eligibility criteria or is using or has attempted to use the Card inconsistently with these terms and conditions. Eligibility criteria, and terms and conditions for the Olumiant Savings Card Program may change from time to time; the most current version can be found at [https://www.olumiant.lilly.com/savings-support](https://olumiant.lilly.com/savings-support). You may be required to obtain a new Card, including if any Card terms and conditions have been terminated, rescinded, revoked, or amended by Lilly. Card void where prohibited by law. Subject to Lilly's right to terminate, rescind, revoke or amend Card eligibility criteria and/or Card terms and conditions, which may occur at Lilly's sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
[Dermatology Enrollment Form](https://olumiant.lilly.com/assets/pdf/derm_olumiant_enrollment_form_digital.pdf)
[Rheumatology Enrollment Form](https://olumiant.lilly.com/assets/pdf/prc_olumiant_csp_rx_enrollment_form_digital.pdf)
For more information about Lilly’s privacy practice, please view the Privacy Statement.
## Enrolling an Olumiant Patient:
### Expand accordion Specialty Pharmacies
1. For eligible, commercially insured patients: Access Olumiant through a specialty pharmacy that is convenient for patients.
2. Over 150 specialty pharmacies can dispense Olumiant
3. [Enhanced Specialty Pharmacy Partners](https://olumiant.lilly.com/assets/pdf/enhanced_sp_partners.pdf) can accept a prescription for Olumiant in 1 of 3 ways:
- a. Electronic prescription
- b. Lilly Support Services™ for Olumiant enrollment form
- c. Specialty pharmacy enrollment form
### Expand accordion CoverMyMeds
1. Submit your prior authorization request digitally through CoverMyMeds. No paper forms or fax machines. To sign in or create an account, visit
[covermymeds.com](https://www.covermymeds.com/main/)
2. Prior Authorization Outcome:
- a. Approved:
- i. If the patient's prior authorization is approved, the patient's insurance may require that the prescription be transferred to the payer preferred specialty pharmacy
- ii. You can send an email to your eligible commercially insured patients to enroll in the Olumiant copay card right in your CoverMyMeds workflow
- b. Denied:
- i. If your patient's prior authorization is denied, CoverMyMeds will prompt you to enroll your commercially insured patients in Lilly Support Services™ for Olumiant where they can access the Olumiant $25 savings card program while coverage is being pursued
3. Services:
- a. Digitally submit prior authorizations through CoverMyMeds and get a response in as quickly as a few hours
- b. Access to a digital Lilly Support Services™ enrollment form that can be prepopulated with the information from the prior authorization form and capture a digital signature even if the patient has left the office
- c. Email your commercially insured patients to ensure they are aware and can enroll in the Olumiant copay card program
### Expand accordion Lilly Patient Support Provider Portal
With the Lilly Patient Support Provider Portal, office sites are able to digitally enroll patients in Lilly Support Services™ for Olumiant and utilize services to help with access and coverage assistance.
The Lilly Patient Support Provider Portal provides:
- Simplified and easy-to-use digital enrollment process
- Convenient electronic options to obtain patient Health Insurance Portability and Accountability Act (HIPAA) authorization signature
- Ability to view real-time patient status information and case history for all patients enrolled by the office (fax, phone, or Provider Portal)
- Enables HCP offices to receive reminder alerts for important tasks necessary to help patients start treatment as early as possible
- Secure Messaging Feature allows users to communicate directly with Lilly Support Services™ for Olumiant regarding their cases and patients
- Access eEligibility (electronic eligibility) or ePA (electronic prior authorization) services to confirm patients’ eligibility and coverage (summary of benefits)
[Sign-up for access to the Lilly Patient Support Provider Portal](https://www.lillypatientsupport.com/)
### Expand accordion Lilly Support Services™ for Olumiant Offerings
**Access and Coverage**
**Insurance Benefits Investigation**
- Help with preliminary insurance investigation
- Identify in-network specialty pharmacy options and out-of-pocket costs
- Provides templates of Coverage Authorization Request Letters, Coverage Authorization Appeal Letters, and Letters of Medical Necessity
**Field Reimbursement Manager (FRM) Support**
- Your FRM is an experienced access professional who is committed to helping navigate the complex access and reimbursement environment to help patients get access to Olumiant.
- Your FRM is:
- **Knowledgeable.** Understands Lilly Support Services™, access challenges, support and affordability options for eligible, commercially insured patients
- **Connected.** Integrated with the Lilly Support Services™ call center and under the Olumiant Enhanced Specialty Pharmacy Network
**Support for your patients beyond access, coverage, and savings**
**Ongoing Support**
- One-on-one support to help answer questions about Olumiant
- Assistance confirming continued eligibility for the Olumiant Savings Card\*
- Help is available Monday through Friday 8 AM to 10 PM ET
\* This information is not a guarantee of coverage or payment (partial or full) and is subject to change without notice by a health plan or state. Please contact the plan or state for the most current information. Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures.
Employers and employer groups may also offer additional benefit designs, which may be different than described.
**Share with your patients they can also enroll in Lilly Support Services for Olumiant with the Lilly Together™ app**
To get started, patients can search for “Lilly Together” in the App Store® or on Google Play™ to download the app. Once signed in, patients can:
- Access their savings card information directly through the app so it’s always with them
- Use symptom tracking to help them understand progress and stay motivated on treatment, and give you a more complete view of their symptom information all in one place the next time you meet
- Connect with a Companion in Care™ team member for ongoing support
- Browse helpful resources and hear from other patients on Olumiant all inside the app
**Additional options for enrollment include submitting to** [https://patientsupportnow.org](https://patientsupportnow.org/) **with code 8446584268 or fax to Lilly Support Services™ for Olumiant at 1-844-658-4268.**
## Resources
[Coverage Authorization Appeal Letter](https://olumiant.lilly.com/assets/pdf/coverage_authorization_appeal_letter.pdf)
[Letter of Medical Necessity](https://olumiant.lilly.com/assets/pdf/lmn.pdf)
[Prior Authorization Resource Guide](https://olumiant.lilly.com/assets/pdf/ba_olumiant_aa_prior_authorization_resource_2025.pdf)
[Alopecia Areata Scale (AASc)](https://olumiant.lilly.com/assets/pdf/AA-HCP%20AASc%20Resource%202024.pdf)
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant for RA Treatment
[Skip to main content](https://olumiant.lilly.com/rheumatoid-arthritis/treatment#maincontent)
# The real pain of RA is seeing others do for you what you used to do for them
If you have rheumatoid arthritis, physical symptoms such as swelling, pain, and tenderness can take a toll and may force you to make difficult adjustments. Having to ask others for help with things like getting dressed or making dinner can be difficult to accept, as can the realization that you're no longer able to be there for your friends and family like you once were.
The good news? Olumiant can help to make daily activities easier, allowing you to do more for yourself and your loved ones.
## Olumiant can help give some people a better sense of control over their RA
The more control you have over your RA, the less control it may have over your daily activities. People who took Olumiant reported improved physical function in activities like:
- Bathing
- Getting dressed
- Walking
- Running errands
- Cooking dinner
The right RA treatment may help you get back to doing the things that are important to you. Setting personalized treatment goals with your doctor may help you start to get back to the things that make you, you.
[Talk to your doctor](https://olumiant.lilly.com/rheumatoid-arthritis/what-is-olumiant?section=talking-to-your-doctor)
### **Select Safety Information**
**Olumiant may cause serious side effects, including:**
**Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in patients taking Olumiant were serious.
## Why The Right Treatment Matters
It’s important to find a treatment so that your RA doesn’t get worse over time. RA can permanently damage the bones and joints if left untreated.
It can be useful to track your symptoms and communicate with your doctor about how you’re feeling. Even small changes you notice can help with managing your RA. The more your healthcare provider knows about your health and how your RA symptoms are affecting your life, the easier it will be to find a treatment that works best for you and your RA.
## When a TNF biologic isn’t enough
Olumiant can work for people who have already tried other rheumatoid arthritis treatments, including TNF biologics such as Humira® (adalimumab), Enbrel® (etanercept), or Remicade® (infliximab).
Talk to your doctor to determine if Olumiant might be right for you.
Trademarks are the property of their respective trademark owners.
[Talking to your doctor](https://olumiant.lilly.com/rheumatoid-arthritis/what-is-olumiant?section=talking-to-your-doctor)
Want to know more about Olumiant and whether it may be able to help you?
[Learn More](https://olumiant.lilly.com/rheumatoid-arthritis/what-is-olumiant)
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant for RA
[Skip to main content](https://olumiant.lilly.com/rheumatoid-arthritis/what-is-olumiant#maincontent)
**Olumiant (baricitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.**
# Your signs and symptoms may improve in as few as 7 days
In a study, some people taking Olumiant experienced a 20% improvement in the signs and symptoms of their RA in as few as 7 days. Others saw results in 12 weeks.
Olumiant may help people with RA experience fewer signs and symptoms such as:
- Joint pain
- Swelling
- Tenderness
### **Select Safety Information**
**Olumiant may cause serious side effects, including:**
**Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
## How does Olumiant work?
Olumiant is a Janus kinase (JAK) inhibitor. JAK inhibitors help disrupt how cells respond to some cytokines. Cytokines are proteins that allow cells to communicate with each other, and excess cytokines may cause inflammation. In RA, joint inflammation may cause pain, swelling, and tenderness. It is not known which disrupted cytokines are most related to the therapeutic effects of Olumiant.
Olumiant is not indicated for children.
## Talking to your doctor
It's important to track your rheumatoid arthritis (RA) symptoms and talk to your doctor about how you're feeling. Even mentioning small things that have changed can help with managing your RA. The more your doctor knows about your overall health and how your symptoms are affecting your ability to do things at work and at home, the better prepared he or she will be to evaluate which treatment is most appropriate for you.
To get started, you may want to ask yourself these following questions:
- Am I noticing changes in my RA symptoms, such as joint pain, stiffness, or swelling?
- If joint swelling was present, has it decreased or does it still persist?
- Have I seen changes in my physical function in performing day-to-day tasks?
- How many times a week am I feeling like I’ve had a “good” day with RA?
- What does a "good" day with RA mean for me?
- Am I able to do the tasks I enjoy doing?
- What is something I have trouble doing because of my RA? How do I go about doing that thing differently because of my RA?
- What are some of the activities I'd do more often if my RA was better controlled?
- Have I taken too many sick days?
Additional helpful resources and tools are available from the Arthritis Foundation at [arthritis.org](https://www.arthritis.org/).
## Find a rheumatologist
A rheumatologist is important for your care. To find one in your area, please access this tool from our partners at the Arthritis Foundation.
[Find a doctor](https://www.arthritis.org/find-a-doctor)
## Explore our patient support services
[Lilly Support Services™ for Olumiant®](https://olumiant.lilly.com/savings-support#lilly-support-services)
Important Safety Information and Indication or Indications. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
INDICATIONS
Important Safety Information and Indication or Indications. Select to Expand.
Important Safety Information. Select to Expand.
SAFETY SUMMARY WITH WARNINGS
Important Safety Information. Select to Expand.
## SAFETY SUMMARY WITH WARNINGS
**WARNINGS -Olumiant may cause serious side effects, including:**
- **Serious infections,** including tuberculosis (TB), shingles, and others caused by bacteria, fungi, or viruses. Some people have died from these infections. Olumiant can make you more likely to get infections or make any infections that you have worse. Your doctor should test for TB before starting Olumiant and watch for TB symptoms during treatment. You should not start Olumiant if you have any kind of infection unless your doctor tells you it is okay. While taking Olumiant, tell your doctor right away if you have symptoms of an infection, such as:
- fever, sweating, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning with urination or urinating more often than normal
- feeling tired
If you get a serious infection, your doctor may stop Olumiant until your infection is controlled.
- **Increased risk of death in people 50 years of age or older who have at least 1 heart disease risk factor and are taking a medicine in a class of medicines called JAK inhibitors.**
- **Cancer and immune system problems.** Olumiant may increase your risk of lymphoma and other cancers, including skin cancers. People taking a medicine in the class of medicines called JAK inhibitors have a higher risk of certain cancers, including lymphoma and lung cancer, especially if you are a current or past smoker. Follow your doctor’s advice about having your skin checked for skin cancer while taking Olumiant.
- **Increased risk of major cardiovascular events such as heart attack, stroke or death in people 50 years of age and older who have at least 1 heart disease risk factor and taking a medicine in the class of medicines called JAK inhibitors, especially if you are a current or past smoker.** Get emergency help right away if you have any symptoms of a heart attack or stroke while taking Olumiant, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- **Blood clots** in the veins of your legs or lungs, and arteries. This may be life-threatening and cause death. Blood clots in the veins of legs and lungs have happened more often in people who are 50 years of age or older and with at least 1 heart disease risk factor taking a medicine in the class of medicines called JAK inhibitors. Stop taking Olumiant and tell your doctor or get emergency help right away if you have any signs and symptoms of blood clots, including swelling, pain or tenderness in the leg, sudden chest pain, or shortness of breath, while taking Olumiant.
- **Allergic reactions.** While taking Olumiant, if you have symptoms, such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, stop taking Olumiant and get emergency help right away. Some of these reactions seen in people taking Olumiant were serious.
- **Tears in the stomach or intestines.** This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. While taking Olumiant, tell your doctor right away if you have fever and stomach-area pain that does not go away, and a change in bowel habits.
- **Changes in laboratory test results.** Your doctor should do blood tests before and while taking Olumiant. You should not take Olumiant if your white or red blood cell count is too low or your liver tests are too high. Your doctor may pause your treatment with Olumiant because of changes in these test results. Your doctor should also check your cholesterol levels approximately 12 weeks after you start Olumiant and as needed.
#### Common side effects
The most common side effects of Olumiant in people treated for alopecia areata include:
- upper respiratory tract infections (cold or sinus infections)
- headache
- acne
- increased cholesterol levels
- increased muscle enzyme levels
- urinary tract infection
- increased liver enzyme levels
- inflammation of hair follicles (folliculitis)
- tiredness
- lower respiratory tract infections
- nausea
- genital yeast infection
- low red blood cell count (anemia)
- low white blood cell count (neutropenia)
- stomach-area (abdominal) pain
- shingles (herpes zoster)
- increased weight
The most common side effects of Olumiant in people treated for rheumatoid arthritis include:
- upper respiratory tract infections (cold or sinus infections)
- nausea
- herpes simplex virus infections, including cold sores
- shingles (herpes zoster)
These are not all the possible side effects of Olumiant. Tell your doctor if you have any side effects.
**You can report side effects to the FDA at 1-800-FDA-1088 or** [www.fda.gov/medwatch](https://www.fda.gov/medwatch).
#### Before using
Before you use Olumiant, tell your doctor if you:
- Are being treated for an infection, have an infection that won’t go away or keeps coming back, or think you have symptoms of an infection.
- Have TB or have been in close contact with someone with TB.
- Have had shingles (herpes zoster).
- Have had hepatitis B or C, cancer, or blood clots in the veins of your legs or lungs.
- Live, have lived, or have visited parts of the country that increase your risk of fungal infections. These may include the Ohio and Mississippi River valleys and the Southwest. Ask your doctor if you do not know if you have lived in an area where these infections are common.
- Are a current or past smoker.
- Have had a heart attack, other heart problems or stroke.
- Have other medical conditions, including kidney or liver problems, low blood cell counts, diabetes, lung disease, HIV, or a weak immune system.
- Have any stomach-area pain or have been diagnosed with inflammation in the large intestine (diverticulitis) or ulcers in your stomach or intestines.
- Have recently received or plan to receive a vaccine. People taking Olumiant should not receive live vaccines.
- Are pregnant or plan to become pregnant. It is not known if Olumiant may harm your unborn baby. If you become pregnant while taking Olumiant, call Eli Lilly and Company at 1-800-545-5979 to report the pregnancy.
- Are breastfeeding or plan to breastfeed. You should not breastfeed while taking Olumiant and for 4 days after the last dose. Talk to your doctor about the best way to feed your baby while taking Olumiant.
- Are taking other medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. It is especially important to tell your doctor, if you take:
- a medicine called probenecid
- medicines that affect your immune system, such as biologic medications, other JAK inhibitors, or strong immunosuppressants (such as azathioprine or cyclosporine) since these may increase your risk of infection.
- Are under age 18. It is not known if Olumiant is safe and effective in children.
#### How to take
- Take Olumiant exactly as your doctor says.
- Take Olumiant once a day by mouth with or without food.
- Talk to your doctor if you cannot swallow tablets whole.
- If you take too much Olumiant, call your doctor or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
#### Learn more
Olumiant is a prescription medicine. For more information, call 1-800-545-5979.
This summary provides basic information about Olumiant but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Olumiant and how to take it. Your doctor is the best person to help you decide if Olumiant is right for you.
BA CON BS 14SEP2022
**Please see full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
Indication or Indications. Select to Expand.
## INDICATIONS
Olumiant® (O-loo-me¯-ant) is a Janus kinase (JAK) inhibitor used to treat:
- adults with severe alopecia areata.
- adults with moderately to severely active rheumatoid arthritis after treatment with 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well enough or could not be tolerated.
## Olumiant Efficacy Overview
[Skip to main content](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy#maincontent)
# Efficacy
## Olumiant was studied as monotherapy in two phase 3 trials for adults with severe alopecia areata3,4
The primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36
**BRAVE-AA1 and BRAVE-AA2 Clinical Trial Design\***
Up
Image Description
Olumiant was studied in 2 clinical trials. BRAVE-AA1 was a phase 2/3 trial that enrolled 654 patients in the phase 3 portion. BRAVE-AA2 was a phase 3 trial that enrolled 546 patients. Patients were randomized 2:2:3 to placebo, Olumiant 2 mg, or Olumiant 4 mg once daily. The primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36.
\*BRAVE-AA1 was a phase 2/3 clinical trial and BRAVE-AA2 was a phase 3 clinical trial. Patient population shown for BRAVE-AA1 is for the phase 3 portion only.
Olumiant was studied in adults with SALT score ≥50 and a current alopecia areata (AA) episode lasting >6 months and <8 years in duration.
**Select inclusion criteria**
- Males (18 to 60 years of age) and females (18 to 70 years of age)
- No spontaneous improvement over the past 6 months
- Patients with severe AA lasting ≥8 years were eligible only if episodes of regrowth were observed on affected areas over the past 8 years
SALT=Severity of Alopecia Tool.
## Patients in the clinical trials had severe alopecia areata, with a mean scalp hair loss of 85% at baseline3
### Expand accordion **Patient baseline characteristics**
**Patient Baseline Characteristics—Pooled Analysis From BRAVE-AA1 and BRAVE-AA2**
| | Placebo (n=345) | Olumiant 2 mg/day (n=340) | Olumiant 4 mg/day (n=515) |
| --- | --- | --- | --- |
| **Age (years), mean (SD)** | Placebo (n=345): 37 (13) | Olumiant 2 mg/day (n=340): 38 (13) | Olumiant 4 mg/day (n=515): 37 (13) |
| **Female** | Placebo (n=345): 60% | Olumiant 2 mg/day (n=340): 62% | Olumiant 4 mg/day (n=515): 60% |
| **Race** | | | |
| White | Placebo (n=345): 49% | Olumiant 2 mg/day (n=340): 55% | Olumiant 4 mg/day (n=515): 52% |
| Asian | Placebo (n=345): 38% | Olumiant 2 mg/day (n=340): 37% | Olumiant 4 mg/day (n=515): 35% |
| Black or African descent | Placebo (n=345): 10% | Olumiant 2 mg/day (n=340): 6% | Olumiant 4 mg/day (n=515): 9% |
| **Duration since AA onset (years), mean (SD)** | Placebo (n=345): 12 (11) | Olumiant 2 mg/day (n=340): 13 (11) | Olumiant 4 mg/day (n=515): 12 (11) |
| **Duration of current AA episode (years), mean (SD)** | Placebo (n=345): 4 (5) | Olumiant 2 mg/day (n=340): 4 (5) | Olumiant 4 mg/day (n=515): 4 (3) |
| <4 years | Placebo (n=345): 66% | Olumiant 2 mg/day (n=340): 68% | Olumiant 4 mg/day (n=515): 64% |
| ≥4 years | Placebo (n=345): 34% | Olumiant 2 mg/day (n=340): 32% | Olumiant 4 mg/day (n=515): 36% |
| **Patients with universalis** | Placebo (n=345): 41% | Olumiant 2 mg/day (n=340): 45% | Olumiant 4 mg/day (n=515): 46% |
| **Patients with atopic background\*** | Placebo (n=345): 41% | Olumiant 2 mg/day (n=340): 38% | Olumiant 4 mg/day (n=515): 36% |
| **SALT score, mean (SD)** | Placebo (n=345): 85 (18) | Olumiant 2 mg/day (n=340): 86 (18) | Olumiant 4 mg/day (n=515): 85 (18) |
\*Atopic background is defined as medical history of or ongoing atopic dermatitis, allergic rhinitis, allergic conjunctivitis, or allergic asthma.
[See Study Designs](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy#study-designs)
[Understanding SALT Scores](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy#salt)
SALT=Severity of Alopecia Tool; SD=standard deviation.
**DOSING INFORMATION**
**The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response with 4 mg/day.**
SALT Score ≤20 at Week 36 & 52
Down
SALT Score ≤20 at Week 36 & 52
SALT Score ≤20 by Baseline Severity
SALT score ≤20 by Duration of Episode
For adults with severe alopecia areata
## Complete or near-complete hair regrowth (≤20) by week 36 and continued through week 521-7\*
### Some patients achieved a SALT score ≤20 as early as week 16†
BRAVE-AA1: Percentage of Patients Who Achieved a SALT Score ≤20 Through Week 52, NRIa
Up
Image Description
In BRAVE-AA1, 7%, 11%, 22%, 21% of patients on Olumiant 2 mg/day (N=184), and 19%, 27%, 35%, 41% of patients on Olumiant 4 mg/day (N=281), at weeks 16, 24, 36, and 52 respectively, achieved a SALT score ≤20 versus 4%, 5%, and 5% of patients on placebo (N=189) at weeks 16, 24, and 36 ( _p_ ≤0.05 for Olumiant 4 mg at week 16 vs placebo and for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.
BRAVE-AA2: Percentage of Patients Who Achieved a SALT Score ≤20 Through Week 52, NRIa
Up
Image Description
In BRAVE-AA2, 8%, 11%, 17%, 24% of patients on Olumiant 2 mg/day (N=156), and 17%, 28%, 32%, 37% of patients on Olumiant 4 mg/day (N=234), at weeks 16, 24, 36, and 52 respectively, achieved a SALT score ≤20 versus 1%, 1%, and 3% of patients on placebo (N=156) at weeks 16, 24, and 36 respectively ( _p_ ≤0.05 for Olumiant 2 mg at week 36 vs. placebo and Olumiant 4 mg at weeks 24 and 36 vs placebo). The placebo-controlled period ended at week 36.
BRAVE-AA Trials Pooled Results: Median SALT scores were 3 (4 mg/day) and 7 (2 mg/day) among patients who achieved SALT score ≤20 at week 52 (N=296; median baseline SALT score=83)
\*Primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36 compared to placebo. These analyses at week 52 included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their same dose.
In pooled BRAVE-AA trials, SALT score 0 was achieved by week 36 for 3.7% (n=11) of patients on Olumiant 2 mg/day, and 10% (n=46) of patients on Olumiant 4 mg/day, and by week 52 for 6.3% (n=18) of patients on Olumiant 2 mg/day, and 16% (n=70) of patients on Olumiant 4 mg/day.
†In BRAVE-AA1, statistical significance was seen at week 16 in the 4 mg/day arm, but not in the other treatment arms; statistical conclusions cannot be made.
aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
b _p_ ≤0.05 vs placebo.
[See Study Designs](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy#study-designs)
[Understanding SALT Scores](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy#salt)
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO TUBERCULOSIS**
Evaluate patients for active infection prior to initiating Olumiant. Olumiant should not be given to patients with active TB. Test patients for latent TB and if positive, treat with standard antimycobacterial therapy before initiating Olumiant. Monitor patients for development of signs and symptoms of TB, including patients who tested negative for latent TB prior to initiating therapy.
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
## SALT Score ≤20 response rates were higher in patients with a baseline SALT score of 50-94 vs 95-1001,8
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Percentage of Patients Who Achieved a SALT Score ≤20 at Week 36 by Baseline Severity, NRI\*
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In a pooled subgroup analysis of BRAVE-AA1 and BRAVE-AA2, patients were stratified by baseline SALT score 50-94 and 95-100. In patients with baseline SALT score 50-94, 48% of patients on Olumiant 4 mg/day (N=248) achieved SALT ≤20 at week 36 vs 8% on placebo (N=166). In patients with baseline SALT score 95-100, 21% of patients on Olumiant 4 mg/day (N=267) achieved SALT ≤20 at week 36 vs 1% on placebo (N=178). All analyses were NRI.
These pooled subgroup analyses were not controlled for multiplicity; therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.
\*Data collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
[See Study Designs](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=study-designs)
[Understanding SALT Scores](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=salt)
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO VIRAL REACTIVATION**
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before starting therapy with Olumiant.
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
## Earlier treatment with Olumiant (AA episode ≥4 years) resulted in more patients achieving ≥80% scalp hair coverage1,9
BRAVE-AA Trials (Pooled Results): SALT Score ≤20 Response Rates Through Week 52 Based on Duration of Current Episode in Patients with baseline SALT Score 50 to 94, NRI
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BRAVE-AA Trials (Pooled Results): SALT Score ≤20 Response Rates Through Week 52 Based on Duration of Current Episode in Patients with baseline SALT Score 50 to 94, NRI
BRAVE-AA Trials (Pooled Results): SALT Score ≤20 Response Rates Through Week 52 Based on Duration of Current Episode in Patients with baseline SALT Score 50 to 94, NRI
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SALT score ≤20 response rates based on duration of current AA episode in patients with a baseline SALT score 50-94 treated with Olumiant 4 mg/day through week 52.
Data presented are from post-hoc, subgroup analyses; statistical conclusions cannot be made.
Data collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
[See BRAVE-AA trial designs](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=study-designs#study-designs).
AA=alopecia areata; NRI=nonresponder imputation; SALT=Severity of Alopecia tool.
EB/EL Results at Week 36
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EB/EL Results at Week 36
EB/EL Results through Week 52
**For adults with severe alopecia areata**
With Olumiant 4 mg/day, an improvement in eyebrow and eyelash coverage was observed at week 361,2,4,10-12\*
Results shown for patients with substantial eyebrow and eyelash hair loss at baseline
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In BRAVE-AA1, 31% of patients on Olumiant 4 mg/day (N=188) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (N=124) ( _p_ ≤0.05). In BRAVE-AA2, 35% of patients on Olumiant 4 mg/day (N=161) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 4% on placebo (N=112) ( _p_ ≤0.05).
In BRAVE-AA1, 34% of patients on Olumiant 4 mg/day (N=167) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (N=96) ( _p_ ≤0.05). In BRAVE-AA2, 34% of patients on Olumiant 4 mg/day (N=140) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 6% on placebo (N=90) ( _p_ ≤0.05).
All analyses were NRI.
\*The EB ClinRO and EL ClinRO are 4-point scales measuring eyebrow and eyelash hair loss, respectively, ranging from 0 (EB ClinRO: Full eyebrow coverage and no areas of eyebrow hair loss; EL ClinRO: Continuous eyelash line along both eyelids) to 3 (EB ClinRO: No notable eyebrow; EL ClinRO: No notable eyelashes). The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.
†Data collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
‡ _p_ ≤0.05 vs placebo.
[See Study Designs](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=study-designs)
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO MORTALITY**
In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
ClinRO Measure for Eyebrow Hair Loss™ and ClinRO Measure for Eyelash Hair Loss™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
EB ClinRO=Clinician-Reported Outcome Measure for Eyebrow Hair Loss™; EL ClinRO=Clinician-Reported Outcome Measure for Eyelash Hair Loss™; NRI=nonresponder imputation.
**For adults with severe alopecia areata**
## An improvement in eyebrow and eyelash coverage was observed through 52 weeks with Olumiant 4 mg/day13
More patients had an observed improvement in eyebrow and eyelash coverage from week 36 through 5213
BRAVE-AA1 and BRAVE-AA2 (Pooled analysis): Percentage of patients with a ClinRO\* measure for EB hair loss 0,1 with ≥2-point improvement from Week 0 through 52, NRI13†
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Results were pooled for study participants treated with Olumiant 4 mg/day (N=349) from 0 to 52 weeks in the BRAVE clinical trial program. The percentage of patients with a ClinRO measure for eyebrow hair loss equal to zero or one, with a two or greater improvement, at the primary endpoint of week 36 was 33%. After the long term extension at week 52 it was 44%. All analyses were NRI.
BRAVE-AA1 and BRAVE-AA2 (Pooled analysis): Percentage of patients with a ClinRO\* measure for EL hair loss 0,1 with ≥2-point improvement from Week 0 through 52, NRI13
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Results were pooled for study participants treated with Olumiant 4 mg/day (N=307) from 0 to 52 weeks in the BRAVE clinical trial program. The percentage of patients with a ClinRO measure for eyelash hair loss equal to zero or one, with a two or greater improvement, at the primary endpoint of week 36 was 34%. After the long term extension at week 52 it was 45%. All analyses were NRI.
**In patients receiving treatment with 4 mg/day, decrease the dosage to 2 mg/day once patients achieve an adequate response.1**
\*The EB ClinRO and EL ClinRO are 4-point scales measuring eyebrow and eyelash hair loss, respectively, ranging from 0 (EB ClinRO: Full eyebrow coverage and no areas of eyebrow hair loss; EL ClinRO: Continuous eyelash line along both eyelids) to 3 (EB ClinRO: No notable eyebrow; EL ClinRO: No notable eyelashes). The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.10-12
†Data collected after permanent study drug discontinuation or at remote visits due to COVID-19 pandemic were excluded.14
The long-term extension data (Week 36-52) of BRAVE-AA trials were not placebo controlled.15,16
ClinRO Measure for Eyebrow Hair Loss™ and ClinRO Measure for Eyelash Hair Loss™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
ClinRO=Clinician-Reported Outcomes, EB=eyebrows, EL=eyelashes, NRI=nonresponder imputation, SALT=Severity of Alopecia Tool.
[See Study Designs](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=study-designs)
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS**
Malignancies were observed in clinical studies with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) and a higher rate of lymphomas were observed in patients treated with the JAK inhibitor compared with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy in patients with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
**For adults with severe alopecia areata**
Visible results with Olumiant through week 361,17-19
See the difference Olumiant can make
**Scalp Hair Results**
**Patient 1**
Clinical trial patient treated with Olumiant 2 mg/day for 36 weeks. Individual results may vary.\*
**Patient 2**
Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.\*
**Patient 3**
Clinical trial patient treated with Olumiant 2 mg/day for 36 weeks. Individual results may vary.\*
**Patient 4**
Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.\*
Patient hairstyles may influence appearance of SALT scores depicted.
\*Based on the pooled post-hoc, placebo-controlled analysis of patients who achieved the primary endpoint (SALT score ≤20 at week 36) in BRAVE-AA trials, the observed mean SALT score at week 36 was 8.6 (SD: 6.7) among patients treated with Olumiant 2 mg/day (N=67) and the observed mean SALT score at week 36 was 6.4 (SD: 6.5) among patients treated with Olumiant 4 mg/day (N=175).18
[See Study Designs](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy#study-designs)
[Understanding SALT Scores](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy#salt)
**Eyebrow and Eyelash Results**
Clinical trial patients treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.
The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.10
[Explore Efficacy Data](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy)
[See Study Designs](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy?section=study-designs)
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO MAJOR ADVERSE CARDIOVASCULAR EVENTS**
In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of MACE (defined as cardiovascular death, non-fatal MI, and non-fatal stroke) was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.
EB ClinRO=Clinician-Reported Outcome Measure for Eyebrow Hair Loss™; EL ClinRO=Clinician-Reported Outcome Measure for Eyelash Hair Loss™; SALT=Severity of Alopecia Tool; SD=standard deviation.
**For adults with severe alopecia areata**
## Long-term extension study design: Responders (SALT score ≤20) at week 52 were eligible for re-randomization15\*
BRAVE-AA1 and BRAVE-AA2: Long-Term Extension Study Design15-17
**The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response with 4 mg/day.1**
\*Sub-study eligible responders (SALT score ≤20) were re-randomized. Patients randomized to placebo at baseline, rescued to Olumiant at week 36, and had a SALT score ≤20 at week 52 were not eligible for re-randomization.15,16,20
†In BRAVE-AA2, patients randomized to Olumiant 2 mg QD at baseline and had a SALT score ≤20 at week 52 remained on their same dose.
PBO=placebo, SALT=Severity of Alopecia Tool.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO THROMBOSIS**
Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), was observed at an increased incidence in Olumiant-treated patients compared to patients treated with placebo. Arterial thrombosis events in the extremities have also reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers. If clinical features of DVT/PE or arterial thrombosis occur, discontinue Olumiant and promptly evaluate and appropriately treat patients. Avoid Olumiant in patients that may be at increased risk for thrombosis.
[Explore 36 Week Efficacy Data](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy#dosing-information)
See Study Designs
**For adults with severe alopecia areata**
## 3-year sustained response rates3,14-16,20\*
Among patients on Olumiant who achieved a SALT score ≤20 at 1 year, most sustained ≥80% scalp coverage through 3 years
BRAVE-AA Trials (Pooled Results): Percentage of Responders Who Sustained a SALT Score ≤20 Through Week 152, LOCFa
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BRAVE-AA1 and BRAVE-AA2 (Pooled Results): 84% of responders on Olumiant 2mg/day (N=67) and 89% of responders on Olumiant 4mg/day (N=129) sustained a SALT score ≤20 from week 52 to week 152.
**The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day when an adequate response has been achieved.**
**Study Design:** In the BRAVE-AA trials, patients randomized to Olumiant 4 mg or 2 mg remained on treatment until week 52. At week 52, responders (SALT score ≤20; N=278) were re-randomized to either: treatment continuation (both trials), withdrawal to placebo (BRAVE-AA1) or down-titration from 4 mg to 2 mg (BRAVE-AA2).
**Down-Titration Efficacy:** In BRAVE-AA2, 59% of patients (N=42) on Olumiant who achieved a SALT score ≤20 at week 52 sustained ≥80% scalp coverage through week 152 when their dose was reduced from Olumiant 4mg/day to 2mg/day.
\*,aLOCF analysis excludes study drug discontinuation or dose change after week 52.
The long-term extension data of BRAVE-AA trials were not placebo controlled.
LOCF=last observation carried forward; SALT=Severity of Alopecia Tool.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
**For adults with severe alopecia areata**
## BRAVE-AA1: Among patients on Olumiant who achieved a SALT score ≤20 at week 52, few sustained a SALT score ≤20 after discontinuing treatment21\*
BRAVE-AA1: Percentage of Responders Who Sustained a SALT Score ≤20 From Week 52 to Week 104 After Discontinuing Treatment, MI+NRIa
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BRAVE-AA1: 10% of responders who switched from 2 mg/day to placebo (N=10) and 20% of responders who switched from 4 mg/day to placebo (N=30) sustained a SALT score ≤20 from week 52 to week 104.
**The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response with 4 mg/day.1**
\*,aMI+NRI analysis excludes data after permanent study drug discontinuation, treatment switch after week 52 visit, or collected at remote visits due to the COVID-19 pandemic. Missing data due to COVID-19 were imputed by MI; data missing for other reasons were imputed as nonresponse.
These analyses included BRAVE-AA1 responders (SALT score ≤20) at week 52 who were randomized from Olumiant 2 mg/day and Olumiant 4 mg/day to placebo withdrawal.
The study population sample size should be taken into consideration when evaluating these data.
[See BRAVE-AA1 and BRAVE-AA2 Long-Term Extension trial design](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy#long-term-results)
MI=multiple imputation; NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical trials. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients presenting with new onset abdominal symptoms for early identification of gastrointestinal perforation.
Evaluate ANC, ALC, hemoglobin, and liver enzymes at baseline and thereafter according to routine patient management.
Dose Titration Results
Down-Titration
Down
Down-Titration
Up-Titration
**For adults with severe alopecia areata**
SALT score ≤20 response rate after decreasing the treatment dose for responders
Among patients on Olumiant who achieved a SALT score ≤20 at 1 year, over half sustained ≥80% scalp coverage through year 3, after their dose was lowered1,22,23
**BRAVE-AA2 Down-Titration Period (Weeks 52-152): Percentage of Responders Who Sustained a SALT Score ≤20, LOCF\***
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BRAVE-AA2 (Weeks 52-152): 59% of responders (N=42) sustained a SALT score ≤20 when their dose was reduced from Olumiant 4 mg/day to 2 mg/day.
**In patients receiving treatment with 4 mg/day, decrease the dosage to 2 mg/day once patients achieve an adequate response.**
Patients randomized to Olumiant 4 mg or 2 mg remained on treatment until week 52, and then responders (SALT score ≤20) on Olumiant 4 mg (N=85) either continued treatment or down-titrated to 2 mg.
\*LOCF excludes study drug discontinuation or dose change after week 52.
The long-term extension data of BRAVE-AA2 were not placebo controlled.
LOCF=last observation carried forward; SALT=Severity of Alopecia Tool.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO LABORATORY ABNORMALITIES**
In clinical trials, Olumiant treatment was associated with:
- **Neutropenia:** Avoid Olumiant initiation or interrupt Olumiant treatment in patients with absolute neutrophil count (ANC) <1000 cells/mm3.
- **Lymphopenia:** Avoid Olumiant initiation or interrupt treatment in patients with absolute lymphocyte count (ALC) <500 cells/mm3.
- **Anemia:** Avoid Olumiant initiation or interrupt treatment in patients with hemoglobin <8 g/dL.
- **Liver enzyme elevations:** Promptly investigate cause of liver enzyme elevations. If alanine transaminase (ALT) or aspartate transaminase (AST) is increased and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
- **Lipid elevations:** Assess lipid parameters approximately 12 weeks after initiating Olumiant and follow clinical guidelines for the management of hyperlipidemia.
Evaluate ANC, ALC, hemoglobin, and liver enzymes at baseline and thereafter according to routine patient management.
**For adults with severe alopecia areata**
## SALT score ≤20 response rates after increasing the treatment dose for responders24
Among patients on Olumiant 2 mg/day who were non-responders at week 52, 26% achieved SALT score ≤20 at week 76 after the treatment dose was increased to Olumiant 4 mg/day24
BRAVE-AA1 and BRAVE-AA2 Up-titration Period (Pooled analysis): Percentage of Patients Who Achieved a SALT Score ≤20 (Week 52 to 76), NRI24\*
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Among patients on Olumiant 2 mg/day who were non-responders at week 52, 26% achieved SALT score ≤20 at week 76 after the treatment dose was increased to Olumiant 4 mg/day23
**In patients receiving treatment with 4 mg/day, decrease the dosage to 2 mg/day once patients achieve an adequate response.22**
Eligible non-responders (SALT score >20) in the Olumiant 2 mg/day treatment arm were transitioned to Olumiant 4 mg/day at week 52 and continue through week 76.24
\*Excludes data collected after permanent study drug discontinuation.24
The long-term extension data of BRAVE-AA trials were not placebo controlled.15,16
NRI=nonresponder imputation, SALT=Severity of Alopecia Tool.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
Severity of Alopecia Tool (SALT)
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Severity of Alopecia Tool (SALT)
Alopecia Areata Scale (AASc)
## The Severity of Alopecia Tool (SALT) is used to measure scalp hair loss in alopecia areata22,23
**SALT measures scalp hair loss on a scale of 0 to 100**
Image is for illustrative purposes only and is not representative of specific patients or efficacy data.
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Image Description
The SALT score, which ranges from 0-100, can be used to assess scalp hair loss. A SALT score 100 indicates complete hair loss and a SALT score 0 indicates no hair loss.
**SALT Score**
The SALT score, which ranges from 0-100, can be used to assess scalp hair loss, and is calculated by multiplying the percentage of hair loss in the quadrant by the percentage of scalp surface area of that quadrant (left: 18%; right: 18%; top: 40%; posterior: 24%) and then adding those percentages together. Only terminal scalp hair areas are assessed, with non-terminal scalp hair areas considered as “missing hair.”
**Interpretation of SALT scores:**
SALT score 100: Complete hair loss
SALT score 50: 50% hair loss
SALT score ≤20: 20% or less hair loss
SALT score 0: No hair loss
## The Alopecia Areata Scale (AASc) is a multidimensional tool for assessing severity of AA25
**Primary Criterion - Severity of Scalp Hair Loss:**
Mild AA <20% Moderate AA 21 to 49% Severe AA 50 to 100%
**Secondary Criteria:**
- Noticeable involvement of eyebrows or eyelashes
- Inadequate response after at least 6 months of treament
- Negative impact on psychosocial functioning resulting frm AA
- Diffuse (multifocal) positive hair pull test consistent with rapidly progressive AA
If **any** secondary criteria are present, **increase** severity rating by **one level**.
**About the AASc**
The AASc is an assessment tool designed to characterize the clinical spectrum of severity of AA. Developed and endorsed by a consensus of disease experts, the AASc incorporates a patient's history and observed hair loss into a descriptive severity rating relevant to clinical practice. A patient's rating on the scale is primarily based on the amount of scalp hair loss, where the rating increases if any of the secondary criteria are present.
The Alopecia Areata Scale is used in clinical settings by dermatologists but has not been used in phase 3 registration trials for AA.
[AASc Resource](https://olumiant.lilly.com/assets/pdf/AA-HCP%20AASc%20Resource%202024.pdf)
**References:**
01. Olumiant. Prescribing Information. Lilly USA, LLC.
02. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. _N Engl J Med._ 2022;386:1687-1699. doi:10.1056/NEJMoa2110343.
03. Data on file. Lilly USA, LLC. DOF-BA-US-0075.
04. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. _N Engl J Med._ 2022;386(suppl):1-76.
05. Data on file. Lilly USA, LLC. DOF-BA-US-0074.
06. Data on file. Lilly USA, LLC. DOF-BA-US-0076.
07. Data on file. Lilly USA, LLC. DOF-BA-US-0122.
08. Data on file. Lilly USA, LLC. DOF-BA-US-0070.
09. Data on file. Lilly USA, LLC. DOF-BA-US-0117.
10. Wyrwich K, Kitchen H, Knight S, et al. Development of clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) measures for eyebrow, eyelash and nail assessment in alopecia areata. _Am J Clin Dermatol._ 2020;21(5):725-732.
11. Data on file. Lilly USA, LLC. DOF-BA-US-0063.
12. Data on file. Lilly USA, LLC. DOF-BA-US-0064.
13. Data on file. Lilly USA, LLC. DOF-BA-US-0104.
14. Data on file. Lilly USA, LLC. DOF-BA-US-0111.
15. Data on file. Lilly USA, LLC. DOF-BA-US-0078.
16. Data on file. Lilly USA, LLC. DOF-BA-US-0090.
17. Data on file. Lilly USA, LLC. DOF-BA-US-0084.
18. Data on file. Lilly USA, LLC. DOF-BA-US-0086.
19. Data on file. Lilly USA, LLC. DOF-BA-US-009.
20. Data on file. Lilly USA, LLC. DOF-BA-US-0105.
21. Data on file. Lilly USA, LLC. DOF-BA-US-0100.
22. Olsen EA, Hordinsky MK, Price VH, et al. Alopecia areata investigational assessment guidelines-part II. _J Am Acad Dermatol._ 2004;51(3):440-447.
23. Data on file. Lilly USA, LLC. DOF-BA-US-0065.
24. Data on file. Lilly USA, LLC. DOF-BA-US-0102.
25. King BA, Mesinkovska NA, Craiglow B, et al. Development of the alopecia areata scale for clinical use: Results of an academic-industry collaborative effort. _J Am Acad Dermatol._ 2022;86(2):359-364. doi:10.1016/j.jaad.2021.08.043.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant Alopecia Areata
[Skip to main content](https://olumiant.lilly.com/hcp/alopecia-areata/getting-patients-started#maincontent)
# Getting Started
**For adults with severe alopecia areata**
## Olumiant offers flexible once-daily dosing1
2mg
Not actual size.
**The recommended dosage is 2 mg once daily.**
Increase the dosage to 4 mg once daily if treatment response is not adequate.
The shape of the Olumiant tablet is a trademark of Eli Lilly and Company.
4mg
Not actual size.
**Consider treatment with 4 mg once daily for patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss.**
Once patients achieve an adequate response to treatment with 4 mg once daily, decrease the dosage to 2 mg once daily.
The shape of the Olumiant tablet is a trademark of Eli Lilly and Company.
For patients with moderate renal impairment (eGFR 30 to <60 mL/min/1.73 m2) or taking strong OAT3 inhibitors (such as probenecid):
- If the recommended dosage is Olumiant 2 mg once daily, reduce to 1 mg once daily
- If the recommended dosage is Olumiant 4 mg once daily, reduce to 2 mg once daily
In addition, if the recommended dosage is 1 mg once daily in a patient taking probenecid, consider discontinuing probenecid.
Olumiant is also available in 1 mg tablets.
The shape of the Olumiant tablet is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries or affiliates.
eGFR=estimated glomerular filtration rate; OAT3=organic anion transporter 3.
**For adults with severe alopecia areata**
## Getting Started with Olumiant
Lab assessments and select treatment considerations with Olumiant1
**Initiation Recommendations for Olumiant:**
a Perform hepatitis screening in accordance with clinical guidelines.
b In addition to evaluation before starting treatment, evaluate thereafter according to routine patient management.
c Patients should be managed according to clinical guidelines for hyperlipidemia.
d Update immunizations in agreement with current guidelines prior to initiating Olumiant.
Treatment can be initiated or restarted after ANC, ALC, or Hgb levels return above specified values, drug-induced liver injury diagnosis is excluded, or infection is controlled.
**Laboratory Abnormalities** – Treatment with Olumiant was associated with an increased risk of neutropenia (ANC <1000 cells/mm3). ALC <500 cells/mm3 and Hgb <8 g/dL were reported in Olumiant clinical trials. Treatment with Olumiant was associated with increased incidence of liver enzyme elevation. Increases of ALT ≥5 times the ULN and increases of AST ≥10 times the ULN were observed in patients taking Olumiant. Treatment with Olumiant was also associated with increases in lipid parameters, including total cholesterol, LDL, and HDL.
**Other Considerations During Routine Treatment:**
- **Hepatic and Renal Impairment** – Olumiant is not recommended in patients with severe renal or severe hepatic impairment. Dosage should be reduced in patients with moderate renal impairment.
- **Serious Infections** – Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant.
- **Tuberculosis** – If positive, treat for latent TB prior to Olumiant use. Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
- **Viral reactivation** – If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. Patients should be monitored for viral reactivation.
ALC=absolute lymphocyte count; ALT=alanine aminotransferase; ANC=absolute neutrophil count; AST=aspartate aminotransferase; HDL=high-density lipoprotein; Hgb=hemoglobin; LDL=low-density lipoprotein; TB=tuberculosis; ULN=upper limit of normal.
[See Dosing and Administration](https://olumiant.lilly.com/hcp/alopecia-areata/getting-patients-started?section=dosing-and-administration)
[See Access and Customer Support Resources](https://olumiant.lilly.com/hcp/support-resources)
[Prior Authorization Resource Guide](https://olumiant.lilly.com/assets/pdf/ba_olumiant_aa_prior_authorization_resource_2025.pdf)
As of 01/2025,
## Olumiant has majority\* commercial access for the treatment of severe alopecia areata in adult patients1,2
Source: Managed Markets Insight & Technology (MMIT), LLC as of 01/2025 and is subject to change without notice. Please contact the plan or state for the most current information.
\*“Majority” access indicates prescription drug plans with pharmacy benefit coverage for Olumiant for the treatment of adults with severe alopecia areata at a status of Covered or Better at 50%+ and within a range of +/-5%. Does not take into consideration any restrictions set forth by individual plans. Data as of 01/2025.
This information is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures.
Employers and employer groups may also offer additional benefit designs, which may be different than described.
[Getting Started Resources](https://olumiant.lilly.com/hcp/support-resources#resources)
**References:**
1. Olumiant. Prescribing Information. Lilly USA, LLC.
2. Data on File. Lilly USA, LLC. DOF-BA-US-0123.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant for Alopecia Areata
[Skip to main content](https://olumiant.lilly.com/hcp/alopecia-areata/patient-profile#maincontent)
**For adults with severe alopecia areata**
# Which of your patients could be considered for Olumiant?1-3
- 18 years or older with patches of hair loss
- May be trying intralesional and/or topical therapies with limited improvement
- Frustrated with the difficulty of trying to hide their hair loss
- Seeking meaningful hair regrowth
_"My hair loss not only alters the way_
_I see myself, but also the way the outside_
_world sees and treats me."_
Real patient photo
Hypothetical quote
_"My hair loss not only alters the way_
_I see myself, but also the way the outside_
_world sees and treats me."_
Real patient photo
Hypothetical quote
**For your patients continuing their treatment journey, see what Olumiant can do**
[Learn More about Olumiant](https://olumiant.lilly.com/hcp/alopecia-areata/efficacy)
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO SERIOUS INFECTIONS**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant. Closely monitor patients for development of infections during and after Olumiant treatment. Interrupt Olumiant if the patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.
* * *
## The JAK–STAT pathway mediates signaling through key cytokines involved in the pathogenesis of alopecia areata4-6
Up
Image Description
The JAK–STAT pathway mediates signaling through key cytokines that are important in the pathogenesis of alopecia areata (AA). Cytokines thought to be involved in AA pathogenesis that signal through the JAK–STAT pathway include, but may not be limited to, IFN-γ, IL-2, IL-7, IL-15, and IL-21. These cytokines bind to their specific cytokine receptors on the cell surface, and this binding leads to the recruitment of intracellular JAKs, which, in turn, recruit, phosphorylate, and activate STATs. Activated STATs translocate to the cell nucleus to modulate gene expression.
Alopecia areata (AA) involves multiple cytokines that signal through the JAK–STAT pathway. Cytokines thought to play a role in AA pathogenesis that signal through the JAK–STAT pathway include, but may not be limited to, IL-2, IL-7, IL-15, and IL-21 and IFN-γ.
- JAKs phosphorylate and activate STATs, which modulate the expression of different genes
- Multiple cytokines have been shown to contribute to the pathophysiology of AA and loss of immune privilege
- These cytokines bind to their respective receptors on the cell surface. This binding leads to the recruitment of intracellular JAKs, which, in turn, recruit, phosphorylate, and activate STATs
- Activated STATs translocate to the cell nucleus to modulate gene expression
The relevance of inhibition of specific JAK proteins to therapeutic effectiveness is not currently known.
IFN-γ=interferon gamma; IL=interleukin; JAK–STAT=Janus kinase-signal transducer and activator of transcription.
* * *
## How does Olumiant work?1
Up
Image Description
Olumiant modulates the JAK signaling pathway, which prevents the phosphorylation and activation of STATs.
- Within the intracellular signaling pathway, JAKs phosphorylate and activate STATs, which modulate gene expression within the cell
- Olumiant modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs
- Within in vitro assays, Olumiant has greater inhibitory potency at JAK1, JAK2, and TYK2 relative to JAK3
The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.
JAK=Janus kinase; STAT=signal transducer and activator of transcription; TYK=tyrosine kinase.
**References:**
1. Olumiant. Prescribing Information. Lilly USA, LLC.
2. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. _N Engl J Med._ 2022;386(18):1687-1699.
3. Data on file. Lilly USA, LLC. DOF-BA-US-0084.
4. Triyangkulsri K, Suchonwanit P. Role of janus kinase inhibitors in the treatment of alopecia areata. _Drug Des Devel Ther._ 2018;12:2323-35.
5. O'Shea JJ, Plenge R. JAK and STAT signaling molecules in immunoregulation and immune-mediated disease. _Immunity._ 2012;36:542-550.
6. O'Shea JJ et al. The JAK-STAT Pathway: Impact on Human Disease and Therapeutic Intervention. _Annu Rev Med._ 2015;66:311-28.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
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**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
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## Olumiant Safety Overview
[Skip to main content](https://olumiant.lilly.com/hcp/alopecia-areata/safety#maincontent)
# Extensive Patient Exposure Over 9 Years1-4\*
**Olumiant has been well-studied and is approved across two immunologic diseases: RA (2018) and AA (2022)**
Unrivaled total exposure in adults with severe AA across clinical trials and real-world use
**1,300+** patients treated
up to **4 years** in the AA clinical trial program†
Post-approval: Over **11,000 patients** have been treated with Olumiant‡
\*Exposure in adults: RA over 9 years and AA up to 4 years.
†As of May 2023, median exposure of 825 days and maximum exposure of 4.0 years across two randomized AA clinical trials (N=1,303).
‡Data cutoff was 07/2024.
AA=alopecia areata; RA=rheumatoid arthritis
* * *
## Alopecia Areata Safety
**SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**_SERIOUS INFECTIONS:_ Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.**
**_MORTALITY:_ Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.**
**_MALIGNANCIES:_ Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE):_ Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_THROMBOSIS:_ Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.**
In adult alopecia areata trials
## Adverse reactions (≥1%) through week 361
**BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Adverse Reactions That Occurred in ≥1% of Patients on Olumiant and More Frequently Than Placebo**
**36-Week Placebo-Controlled Period\***
| | Placebo (N=371) | Olumiant 2 mg/day (N=365) | Olumiant 4 mg/day (N=540) |
| --- | --- | --- | --- |
| Upper respiratory tract infections† | Placebo (N=371): 19.9% | Olumiant 2 mg/day (N=365): 18.4% | Olumiant 4 mg/day (N=540): 21.3% |
| Headache | Placebo (N=371): 5.4% | Olumiant 2 mg/day (N=365): 5.5% | Olumiant 4 mg/day (N=540): 6.6% |
| Acne‡ | Placebo (N=371): 2.2% | Olumiant 2 mg/day (N=365): 5.8% | Olumiant 4 mg/day (N=540): 5.9% |
| Hyperlipidemia§ | Placebo (N=371): 3.0% | Olumiant 2 mg/day (N=365): 3.6% | Olumiant 4 mg/day (N=540): 5.9% |
| Blood creatine phosphokinase increased | Placebo (N=371): 1.3% | Olumiant 2 mg/day (N=365): 0.8% | Olumiant 4 mg/day (N=540): 4.3% |
| Urinary tract infections‖ | Placebo (N=371): 2.2% | Olumiant 2 mg/day (N=365): 3.8% | Olumiant 4 mg/day (N=540): 3.7% |
| Liver enzyme elevations¶ | Placebo (N=371): 2.4% | Olumiant 2 mg/day (N=365): 1.1% | Olumiant 4 mg/day (N=540): 3.0% |
| Folliculitis# | Placebo (N=371): 0.8% | Olumiant 2 mg/day (N=365): 1.4% | Olumiant 4 mg/day (N=540): 2.2% |
| Fatigue | Placebo (N=371): 1.1% | Olumiant 2 mg/day (N=365): 0.8% | Olumiant 4 mg/day (N=540): 2.2% |
| Lower respiratory tract infections\*\* | Placebo (N=371): 0.8% | Olumiant 2 mg/day (N=365): 2.2% | Olumiant 4 mg/day (N=540): 2.0% |
| Nausea | Placebo (N=371): 1.6% | Olumiant 2 mg/day (N=365): 2.7% | Olumiant 4 mg/day (N=540): 2.0% |
| Genital _Candida_ infections†† | Placebo (N=371): 0.3% | Olumiant 2 mg/day (N=365): 2.2% | Olumiant 4 mg/day (N=540): 1.3% |
| Anemia | Placebo (N=371): 0.3% | Olumiant 2 mg/day (N=365): 0.3% | Olumiant 4 mg/day (N=540): 1.3% |
| Neutropenia‡‡ | Placebo (N=371): 0.8% | Olumiant 2 mg/day (N=365): 0.3% | Olumiant 4 mg/day (N=540): 1.3% |
| Abdominal pain§§ | Placebo (N=371): 2.2% | Olumiant 2 mg/day (N=365): 3.8% | Olumiant 4 mg/day (N=540): 0.9% |
| Herpes zoster | Placebo (N=371): 0.5% | Olumiant 2 mg/day (N=365): 1.4% | Olumiant 4 mg/day (N=540): 0.9% |
| Weight increased | Placebo (N=371): 0.3% | Olumiant 2 mg/day (N=365): 1.6% | Olumiant 4 mg/day (N=540): 0.9% |
\*%-study size adjusted percentages.
†Includes acute sinusitis, influenza, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, viral upper respiratory tract infection, viral sinusitis, viral pharyngitis, respiratory tract infection viral, rhinovirus infection, and adenoiditis.
‡Includes acne and dermatitis acneiform.
§Includes hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, dyslipidemia, lipids increased, low density lipoprotein increased, blood cholesterol increased, and blood triglycerides increased.
‖Includes cystitis, urinary tract infection, white blood cells urine positive, urinary tract infection bacterial, and pyelonephritis.
¶Includes transaminases increased, aspartate aminotransferase increased, alanine aminotransferase increased, hepatic enzyme increased, gamma-glutamyl transferase increased, and hepatic function abnormal.
#Was most commonly localized in the scalp region associated with hair regrowth.
\*\*Includes bronchitis, bronchiolitis, lower respiratory tract infection, pneumonia, COVID-19 pneumonia, and respiratory tract infection.
††Includes vulvovaginal candidiasis, vulvovaginal mycotic infection, and genital infection fungal.
‡‡Includes neutropenia and neutrophil count decreased.
§§Includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal discomfort.
In adult alopecia areata trials
## AEs of special interest: 3-year safety update.5-11
**BRAVE-AA1 and BRAVE-AA2 (Pooled Results): AEs of Special Interest\***
**Weeks 0-36**
**(Placebo-Controlled Period)**
**n(%)\[IR/100 PYE\]**
| Adverse Events | Placebo (N=371;PYE=243.2) | Olumiant 2 mg/day (N=365;PYE=240.6) | Olumiant 4 mg/day (N=540;PYE=363.4) |
| --- | --- | --- | --- |
| Adverse Events: Serious infections | Placebo (N=371;PYE=243.2): 0 | Olumiant 2 mg/day (N=365;PYE=240.6): 2 (0.5%)\[0.8\] | Olumiant 4 mg/day (N=540;PYE=363.4): 1 (0.2%)\[0.3\] |
| Adverse Events: Opportunistic infections | Placebo (N=371;PYE=243.2): 0 | Olumiant 2 mg/day (N=365;PYE=240.6): 0 | Olumiant 4 mg/day (N=540;PYE=363.4): 0 |
| Adverse Events: Malignancies other than NMSCa | Placebo (N=371;PYE=243.2): 1 (0.3%)\[0.4\] | Olumiant 2 mg/day (N=365;PYE=240.6): 0 | Olumiant 4 mg/day (N=540;PYE=363.4): 1 (0.2%)\[0.3\] |
| Adverse Events: NMSC | Placebo (N=371;PYE=243.2): 0 | Olumiant 2 mg/day (N=365;PYE=240.6): 0 | Olumiant 4 mg/day (N=540;PYE=363.4): 0 |
| Adverse Events: MACE (adjudicated) | Placebo (N=371;PYE=243.2): 0 | Olumiant 2 mg/day (N=365;PYE=240.6): 1 (0.3%)\[0.4\] | Olumiant 4 mg/day (N=540;PYE=363.4): 0 |
| Adverse Events: DVT/PE (adjudicated) | Placebo (N=371;PYE=243.2): 0 | Olumiant 2 mg/day (N=365;PYE=240.6): 0 | Olumiant 4 mg/day (N=540;PYE=363.4): 0 |
**Weeks 0-152**
**(Extended Safety Analysis)b**
**n\[IR/100 PYE\]**
| Adverse Events | Olumiant 2 mg/day (N=383;PYE=523.25) | Olumiant 4 mg/day (N=565;PYE=1106.70) |
| --- | --- | --- |
| Adverse Events: Serious infections | Olumiant 2 mg/day (N=383; PYE=523.25): 2 \[0.4\] | Olumiant 4 mg/day (N=565; PYE=1106.70): 6 \[0.5\] |
| Adverse Events: Opportunistic infections | Olumiant 2 mg/day (N=383; PYE=523.25): 0 | Olumiant 4 mg/day (N=565; PYE=1106.70): 0 |
| Adverse Events: Malignancies other than NMSCa | Olumiant 2 mg/day (N=383; PYE=523.25): 0 | Olumiant 4 mg/day (N=565; PYE=1106.70): 3\[0.3\] |
| Adverse Events: NMSC | Olumiant 2 mg/day (N=383; PYE=523.25): 1 \[0.2\] | Olumiant 4 mg/day (N=565; PYE=1106.70): 0 |
| Adverse Events: MACE (adjudicated) | Olumiant 2 mg/day (N=383; PYE=523.25): 1 \[0.2\] | Olumiant 4 mg/day (N=565; PYE=1106.70): 0 |
| Adverse Events: DVT/PE (adjudicated) | Olumiant 2 mg/day (N=383; PYE=523.25): 1 \[0.2\] | Olumiant 4 mg/day (N=565; PYE=1106.70): 0 |
**All BARI AAc n\[IR/100 PYE\]**
| Adverse Events | All Doses (N=1303; PYE=2789.69) |
| --- | --- |
| Adverse Events: Serious infections | All Doses (N=1303; PYE=2789.69): 16 \[0.6\] |
| Adverse Events: Opportunistic infections | All Doses (N=1303; PYE=2789.69): 1 \[<0.1\] |
| Adverse Events: Malignancies other than NMSCa | All Doses (N=1303; PYE=2789.69): 7 \[0.2\] |
| Adverse Events: NMSC | All Doses (N=1303; PYE=2789.69): 3 \[01\] |
| Adverse Events: MACE (adjudicated) | All Doses (N=1303; PYE=2789.69): 1 \[<0.1\] |
| Adverse Events: DVT/PE (adjudicated) | All Doses (N=1303; PYE=2789.69): 2 \[0.1\]d |
\*Data includes patients from the BRAVE-AA1 (Phase 2/3) and BRAVE-AA2 (Phase 3) trials, and from a study addendum.
aAll BARI includes the events of prostate cancer (placebo), B-cell lymphoma (Olumiant 4 mg/day), breast cancers (Olumiant 4 mg/day & 2 mg/day), chronic lymphocytic leukemia (Olumiant 2 mg/day), malignant melanoma in situ (Olumiant 2 mg/day), malignant melanoma (Olumiant 4 mg/day) and endometrial cancer (Olumiant 4 mg/day).
bThe extended safety analysis includes patients who were treated continuously on either Olumiant 2mg/day or 4 mg/day from randomization through data cut-off. Data is censored after any dose or treatment change.
cAll BARI AA includes all patients who received a dose of baricitinib at any time during the BRAVE-AA studies. Median exposure for All BARI AA was 825 days.
dOne patient had a DVT and one patient had a DVT/PE.
Certain adverse events, such as MACE and malignancy, require longer observation periods to ascertain risk.
Patients with high risk of DVT/PE, significant cardiac history, current or recent serious infection, or malignancy within 5 years were excluded from clinical trials.
Data cut-off dates for BRAVE-AA trials from weeks 0-36 by February 2021, weeks 0-152 by May 2023.
BARI=baricitinib; DVT=deep vein thrombosis; IR=incidence rate; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; PE=pulmonary embolism; PYE=patient years of exposure.
**SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**_SERIOUS INFECTIONS:_ Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.**
**_MORTALITY:_ Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.**
**_MALIGNANCIES:_ Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE):_ Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_THROMBOSIS:_ Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.**
In adult alopecia areata trials
## Proportion of patients with risk factors for select AEs of special interest at baseline**2,5,12**
About 46% of patients with severe AA had at least one risk factor for select AEs of special interest at baseline\*
**BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Percentage of Patients With Risk Factors at Baseline**
| Risk Factor | Percentage |
| --- | --- |
| Risk Factor **At least one risk factor** | Percentage 46.0% |
| Risk Factor BMI ≥30kg/m2 | Percentage 20.4% |
| Risk Factor History of smokinga | Percentage 17.0% |
| Risk Factor Hypertension | Percentage 11.1% |
| Risk Factor HDL <40 mg/dl | Percentage 8.9% |
| Risk Factor Diabetes mellitus | Percentage 3.1% |
| Risk Factor History of malignancy | Percentage 1.3% |
| Risk Factor ASCVD | Percentage 0.9% |
| Risk Factor Age ≥65 yearsb | Percentage 2.5% |
| Risk Factor Severe mobility impairment (EQ-5D)c | Percentage 0.3% |
AEs of special interest included MACE, malignancies, VTE, serious infections, and mortality.
Individual disease burden, risk factors, and response to treatment should be considered to make an informed decision for individual patients treated with Olumiant.
The risk factors presented are those relevant for the selected AEs of special interest and were assessed as part of an analysis to address questions on JAK inhibitor safety from the EMA.
\*In AA analysis set, data were pooled from BRAVE-AA1 (phase 2/3) and BRAVE-AA2 (phase 3), and all patients who were exposed to any Olumiant dose.
aCurrent or past smoking.
bThe age of participants in the AA clinical trials was limited to ≤60 years for men and ≤70 years for women to reduce concomitant androgenic alopecia.
cSevere mobility impairment indicated by a response of either “I have severe problems in walking about” or “I am unable to walk about.”
AA=alopecia areata; AE=adverse event; ASCVD=atherosclerotic cardiovascular disease; BMI=body mass index; EMA=European Medicines Agency; EQ-5D=EuroQol-5 Dimension; HDL=high-density lipoprotein; JAK=Janus kinase; MACE=major adverse cardiovascular event; VTE=venous thromboembolism.
## An integrated safety analysis across BRAVE-AA clinical trials**2,12**
Analysis of IRs of AEs of special interest in patients with and without specified risk factors\*
**IRs of AEs of Special Interest in Patients With and Without Specified Risk Factors in BRAVE-AA Clinical Trialsa**
| | No Specified Risk Factors (N=704) | ≥1 Specified Risk Factor (N=599) |
| --- | --- | --- |
| MACEb | No Specified Risk Factors (N=704) 0(0) | ≥1 Specified Risk Factor (N=599) 0.12(1) |
| Malignancies excluding NMSCs | No Specified Risk Factors (N=704) 0(0) | ≥1 Specified Risk Factor (N=599) 0.35(3) |
| VTE (DVT/PE)c | No Specified Risk Factors (N=704) 0(0) | ≥1 Specified Risk Factor (N=599) 0.12(1) |
| Serious infections | No Specified Risk Factors (N=704) 0.57(6) | ≥1 Specified Risk Factor (N=599) 1.17(10) |
| All-cause mortality | No Specified Risk Factors (N=704) 0(0) | ≥1 Specified Risk Factor (N=599) 0(0) |
aPooled data from BRAVE-AA trials clinical trials. Total patient-years of exposure was 1868.
bMACE was defined as positively adjudicated events of myocardial infarction, stroke, and cardiovascular deaths combined.
cVTE was defined as DVT or PE.
\*The risk factors were ASCVD, diabetes mellitus, age ≥65 years, hypertension, history of smoking, HDL <40 mg/dL, BMI ≥30 kg/m2, severe mobility impairment as indicated by EQ-5D, or history of malignancy, also including factors only documented in case narrative, such as past smoking.
Individual disease burden, risk factors, and response to treatment should be considered to make informed decisions for individual patients treated with Olumiant.
AA=alopecia areata; AE=adverse event; ASCVD=atherosclerotic cardiovascular disease; BMI=body mass index; DVT=deep vein thrombosis; EQ-5D=EuroQol-5 Dimension; HDL=high-density lipoprotein; IR=incidence rate; MACE=major adverse cardiovascular event; NMSC= nonmelanoma skin cancer; PE=pulmonary embolism; PYE=patient years of exposure; VTE=venous thromboembolism.
**References:**
01. Olumiant. Prescribing Information. Lilly USA, LLC.
02. Taylor PC, Takeuchi T, Burmester GR, et al. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. _Ann Rheum Dis._ 2021;81(3):335-343.
03. King B, Mostaghimi A, Shimomura Y, et al. Safety analysis of baricitinib in adult patients with severe alopecia areata from 2 randomized clinical trials over a median of 2.3 year and up to 4 years of exposure. Poster presented at the American Academy of Dermatology Annual Meeting; 2024 Mar 8-12; San Diego, CA. Abstract 51436.
04. Data on File. Lilly USA, LLC. DOF-BA-US-0118.
05. Data on file. Lilly USA, LLC. DOF-BA-US-0075.
06. Data on file. Lilly USA, LLC. DOF-BA-US-0090.
07. Data on file. Lilly USA, LLC. DOF-BA-US-0078.
08. Data on file. Lilly USA, LLC. DOF-BA-US-0094.
09. Data on file. Lilly USA, LLC. DOF-BA-US-0112.
10. Data on file. Lilly USA, LLC. DOF-BA-US-0113.
11. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. _N Engl J Med._ 2022;386(18):1687-1699.
12. Data on file. Lilly USA, LLC. DOF-BA-US-0116.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
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## Olumiant Alopecia Areata Videos
[Skip to main content](https://olumiant.lilly.com/hcp/alopecia-areata/videos#maincontent)
On-Demand Content
# Watch and learn: Olumiant Video Content
## Expert-Led **Interactive Videos**
Explore interactive videos for content and insights related to the efficacy and safety profile of Olumiant
Efficacy outcomes and long-term patient expectations with Olumiant
Featuring Natasha Mesinkovska, MD, PhD
Up
Transcript
**00:00-00:05**
\[Olumiant logo, video title, and disclaimer appear on screen. The Disclaimer and logo remain visible for the duration of the video. A bar animates in from the side with three Olumiant branding colors\]
**Descriptive Clue:**
The Olumiant Logo includes the text Olumiant (baricitinib) tablets 4 mg, 2 mg, 1 mg.
**Caption:**
\[title\] EFFICACY OUTCOMES AND LONG-TERM PATIENT EXPECTATIONS WITH OLUMIANT
**Caption:**
\[disclaimer footer\]
Please see Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis and full Prescribing Information on the site.
**00:05-00:26**
\[Indication and limitations of use appear on screen\]
**Caption:**
Video to begin after brief Safety Information
**INDICATION:**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata.1
**LIMITATIONS OF USE:**
Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.1
**00:26-02:06**
\[Warning information appears on screen\]
**Caption:**
SELECT IMPORTANT SAFETY INFORMATION:
Warning: serious infections, mortality, malignancy, major adverse cardiovascular events (mace), and thrombosis.
SERIOUS INFECTIONS:
Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
MORTALITY:
Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.
Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.
Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.
Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.
**02:06-02:10**
\[Dr. Mesinkovska's credential information appears on screen\]
**Caption:**
Dr. Natasha Mesinkovska, MD, PhD., is an Associate Professor of Dermatology and Vice Chair of Clinical Research in the UCI School of Medicine's Department of Dermatology in Irvine, California, specializing in the diagnosis and treatment of skin disorders, including skin cancer. Her clinical interests include hair loss, dermatitis, and integrative dermatology. Her research interests include alopecia and dermatitis, and she is the author or co-author of many articles in peer-reviewed publications. In addition, she is an investigator on several current clinical trials involving alopecia, atopic dermatitis, psoriasis, and skin laxity. She also served as the Chief Scientific Officer of the National Alopecia Areata Foundation.
**02:10-02:24**
\[Dr. Mesinkovska appears on screen with credentials animating below her\]
**Caption:**
Dr. Natasha Mesinkovska
MD, PhD, Associate Professor of Dermatology and Vice Chair of Clinical Research, UCI School of Medicine
**02:24-02:28**
\[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors\]
**Caption:**
\[Title\] What results can patients expect from initial treatment?
**02:28-02:41**
\[Dr. Mesinkovska appears on screen and speaks directly to the viewer. There is an eyebrow on the top left in orange color: “FOR ADULTS WITH SEVERE ALOPECIA AREATA”\]
**02:41-02:44**
\[Dr. Mesinkovska appears to the left of the screen, speaking directly to the viewer, while a graphic appears to the right of the screen\]
**Caption:**
\[figure title\] The Severity of Alopecia Tool (SALT) is used to measure scalp hair loss in alopecia areata (AA)2,3
**\[Graphic description\]**
SALT score 100: complete hair loss
SALT score 0: no hair loss
**Caption:**
\[Image disclaimer\]
Image for illustrative purposes only and is not representative of specific patients or efficacy data.
\[footnote\]
SALT is a clinically validated tool used to measure scalp hair loss in AA.2,3
**02:54-03:05**
\[Closeup of Dr. Mesinkovska\]
**03:05-03:23**
\[Dr. Mesinkovska off screen, trial design appears on screen\]
**Caption:**
\[title\] BRAVE-AA1 and BRAVE-AA2 Clinical Trial Design1,4
**Descriptive Clue:**
A schematic shows that BRAVE-AA1 (N=654) and BRAVE-AA2 (N=546) assigned patients to one of the following groups: placebo, Olumiant 2 mg/day or Olumiant 4 mg/day. The primary endpoint was the proportion of patients achieving a SALT ≤20 at week 36. Patients were randomized 2:2:3 (placebo:2 mg:4 mg) at week 0.
**Caption:**
\[footnotes\]
Olumiant was studied in two randomized, double-blind, placebo-controlled clinical trials in adults with a baseline SALT score >50 and a current AA episode lasting >6 months and <8 years in duration.
BRAVE-AA1 was a phase 2/3 trial that enrolled 654 patients in the phase 3 portion. BRAVE-AA2 was a phase 3 trial that enrolled 546 patients.
Patients were randomized 2:2:3 to placebo, Olumiant 2 mg, or Olumiant 4 mg once daily. The primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36.
\[abbreviations\]
SALT=Severity of Alopecia Tool; AA=alopecia areata.
**03:23-04:29**
\[Dr. Mesinkovska appears on screen, speaking directly to the viewer and is then replaced with two graphs appearing on screen with Dr. Mesinkovska narrating\]
**Caption:**
\[slide title\]
Complete or near-complete hair regrowth (SALT ≤20) by week 36 and continued through week 521,4-9,\*
\[graph titles\]
BRAVE-AA1 and BRAVE-AA2: Percentage of Patients Who Achieved a SALT Score ≤20 Through Week 52, NRIa
**Descriptive Clue:**
The two graphs build along the screen and stop at week 36. Across the top is the description that some patients achieved a SALT score ≤20 as early as week 16.
In BRAVE-AA1, 7%, 11%, and 22% of patients on Olumiant 2 mg/day (N=184), and 19%, 27%, and 35% of patients on Olumiant 4 mg/day (N=281), at weeks 16, 24, and 36 respectively, achieved a SALT score ≤20 versus 4%, 5%, and 5% of patients on placebo (N=189) at weeks 16, 24 and 36 (p≤0.05 for Olumiant 4 mg at week 16 vs placebo and for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.
In BRAVE-AA2, 8%, 11%, and 17% of patients on Olumiant 2 mg/day (N=156), and 17%, 28%, and 32% of patients on Olumiant 4 mg/day (N=234), at weeks 16, 24, and 36 respectively, achieved a SALT score ≤20 versus 1%, 1%, and 3% of patients on placebo (N=156) at weeks 16, 24, and 36 respectively (p≤0.05 for Olumiant 2 mg at week 36 vs placebo and Olumiant 4 mg at weeks 24 and 36 vs placebo). The placebo-controlled period ended at week 36.
**Caption:**
\[footnotes\]
The recommended dose is 2 mg/day. Increase to 4 mg/day if response is inadequate. For patients with nearly complete or complete scalp hair loss, or with substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response.
\*Primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36 compared to placebo. These analyses at week 52 included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their same dose.
In pooled BRAVE-AA trials, SALT score 0 was achieved by week 36 for 3.7% (n=11) of patients on Olumiant 2 mg/day, and 10% (n=46) of patients on Olumiant 4 mg/day, and by week 52 for 6.3% (n=18) of patients on Olumiant 2 mg/day, and 16% (n=70) of patients on Olumiant 4 mg/day.
†In BRAVE-AA1, statistical significance was seen at week 16 in the 4 mg/day arm, but not in the other treatment arms; statistical conclusions cannot be made.
aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
bp≤0.05 vs placebo.
\[abbreviations\]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
**04:29-05:05**
**Caption:**
\[slide title\]
Complete or near-complete hair regrowth (SALT ≤20) by week 36 and continued through week 521,4-9,\*
\[graph titles\]
BRAVE-AA1 and BRAVE-AA2: Percentage of Patients Who Achieved a SALT Score ≤20 Through Week 52, NRIa
Descriptive Clue:
The two graphs continue to build to week 52. Across the top is a description that some patients achieved a SALT score ≤20 as early as week 16.
In BRAVE-AA1, 7%, 11%, 22%, and 21% of patients on Olumiant 2 mg/day (N=184), and 19%, 27%, 35%, and 41% of patients on Olumiant 4 mg/day (N=281), at weeks 16, 24, 36, and 52 respectively, achieved a SALT score ≤20 versus 4%, 5%, and 5% of patients on placebo (N=189) at weeks 16, 24 and 36 (p≤0.05 for Olumiant 4 mg at week 16 vs placebo and for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.
In BRAVE-AA2, 8%, 11%, 17%, and 24% of patients on Olumiant 2 mg/day (N=156), and 17%, 28%, 32%, and 37% of patients on Olumiant 4 mg/day (N=234), at weeks 16, 24, 36, and 52 respectively, achieved a SALT score ≤20 versus 1%, 1%, and 3% of patients on placebo (N=156) at weeks 16, 24 and 36 respectively (p≤0.05 for Olumiant 2 mg at week 36 vs placebo and Olumiant 4 mg at weeks 24 and 36 vs placebo). The placebo-controlled period ended at week 36.
**Caption:**
\[footnotes\]
The recommended dose is 2 mg/day. Increase to 4 mg/day if response is inadequate. For patients with nearly complete or complete scalp hair loss, or with substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response.
\*Primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36 compared to placebo. These analyses at week 52 included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their same dose.
In pooled BRAVE-AA trials, SALT score 0 was achieved by week 36 for 3.7% (n=11) of patients on Olumiant 2 mg/day, and 10% (n=46) of patients on Olumiant 4 mg/day, and by week 52 for 6.3% (n=18) of patients on Olumiant 2 mg/day, and 16% (n=70) of patients on Olumiant 4 mg/day.
†In BRAVE-AA1, statistical significance was seen at week 16 in the 4 mg/day arm, but not in the other treatment arms; statistical conclusions cannot be made.
aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
bp≤0.05 vs placebo.
\[abbreviations\]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
**05:05-06:05**
**Caption:**
\[slide title\]
Complete or near-complete hair regrowth (SALT score ≤10) by week 36 and continued through week 521,4-9,\*
\[graph titles\]
BRAVE-AA1 and BRAVE-AA2: Percentage of Patients Who Achieved a SALT Score ≤10 Through Week 52, NRIa
**Descriptive Clue:**
The two graphs build up to week 36.
In BRAVE-AA1, 8%, 13%, and 14% of patients on Olumiant 2 mg/day (N=184), and 18%, 26%, and 30% of patients on Olumiant 4 mg/day (N=281), at weeks 24, 36, and 52 respectively, achieved a SALT score ≤10 versus 3% and 4% of patients on placebo (N=189) at weeks 24 and 36 respectively, (p≤0.05 for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.
In BRAVE-AA2, 8%, 11%, and 17% of patients on Olumiant 2 mg/day (N=156), and 19%, 24%, and 28% of patients on Olumiant 4 mg/day (N=234), at weeks 24, 36, and 52 respectively, achieved a SALT score ≤10 versus 1% of patients on placebo (N=156) at weeks 24 and 36 respectively, (p≤0.05 for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.
**Caption:**
\[footnotes\]
The recommended dose is 2 mg/day. Increase to 4 mg/day if response is inadequate. For patients with nearly complete or complete scalp hair loss, or with substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response.
\*Primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36 compared to placebo. These analyses at week 52 included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their dose.
In pooled BRAVE-AA trials, SALT score 0 was achieved by week 36 for 3.7% (n=11) of patients on Olumiant 2 mg/day, and 10% (n=46) of patients on Olumiant 4 mg/day, and by week 52 for 6.3% (n=18) of patients on Olumiant 2 mg/day, and 16% (n=70) of patients on Olumiant 4 mg/day.
aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
bp≤0.05 vs placebo.
\[abbreviations\]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
**06:05-06:34**
**Caption:**
\[slide title\]
Complete or near-complete hair regrowth (SALT score ≤10) by week 36 and continued through week 521,4,6-9,\*
\[graph titles\]
BRAVE-AA1 and BRAVE-AA2: Percentage of Patients Who Achieved a SALT Score ≤10 Through Week 52, NRIa
Descriptive Clue:
The two graphs continue to build to week 52.
In BRAVE-AA1, 8%, 13%, and 14% of patients on Olumiant 2 mg/day (N=184), and 18%, 26%, and 30% of patients on Olumiant 4 mg/day (N=281), at weeks 24, 36, and 52 respectively, achieved a SALT score ≤10 versus 3% and 4% of patients on placebo (N=189) at weeks 24 and 36 respectively, (p≤0.05 for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.
In BRAVE-AA2, 8%, 11%, and 17% of patients on Olumiant 2 mg/day (N=156), and 19%, 24%, and 28% of patients on Olumiant 4 mg/day (N=234), at weeks 24, 36, and 52 respectively, achieved a SALT score ≤10 versus 1% of patients on placebo (N=156) at weeks 24 and 36 respectively, (p≤0.05 for both doses vs placebo at weeks 24 and 36). The placebo-controlled period ended at week 36.
**Caption:**
\[footnotes\]
The recommended dose is 2 mg/day. Increase to 4 mg/day if response is inadequate. For patients with nearly complete or complete scalp hair loss, or with substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response.
\*Primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36 compared to placebo. These analyses at week 52 included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their dose.
In pooled BRAVE-AA trials, SALT score 0 was achieved by week 36 for 3.7% (n=11) of patients on Olumiant 2 mg/day, and 10% (n=46) of patients on Olumiant 4 mg/day, and by week 52 for 6.3% (n=18) of patients on Olumiant 2 mg/day, and 16% (n=70) of patients on Olumiant 4 mg/day.
aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
bp≤0.05 vs placebo.
See BRAVE-AA trial designs.
\[abbreviations\]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
**06:34-06:39**
\[Dr. Mesinkovska appears on the left side of the screen with a title on the right\]
**Caption:**
\[title\]
See the difference Olumiant can make in your adult patients with severe AA
**06:39-06:48**
\[Dr. Mesinkovska appears on screen and is then replaced by images of the patient's hair regrowth over 36 weeks\]
**Caption:**
\[image title\]
See the difference Olumiant can make through week 361,10-12
**Descriptive Clue:**
Images of the patient's hair at baseline, Week 12 on Olumiant 2 mg/day, and Week 36 on Olumiant 2 mg/day appear. Images show hair regrowth across time points. At baseline, the patient had a SALT Score of 51, and at Week 36, a SALT Score of 14. There is a description above the images indicating that patient hairstyles may influence the appearance of SALT scores depicted.
**Image footnote:**
Clinical trial patient treated with Olumiant 2 mg/day for 36 weeks. Individual results may vary.a
**Caption:**
\[footnotes\]
aBased on the pooled post-hoc, placebo-controlled analysis of patients who achieved the primary endpoint (SALT score ≤20 at week 36) in BRAVE-AA1 and BRAVE-AA2, the observed mean SALT score at week 36 was 8.6 (SD: 6.7) among patients treated with Olumiant 2 mg/day (N=67).
The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.
See BRAVE-AA1 and BRAVE-AA2 trial designs.
\[abbreviations\]
SALT=Severity of Alopecia Tool; SD=standard deviation.
**06:48-06:52**
**Caption:**
\[image title\]
See the difference Olumiant can make through week 36
**Descriptive Clue:**
Images of the patient's hair at baseline, Week 12 on Olumiant 4 mg/day, and Week 36 on Olumiant 4 mg/day appear. Images show hair regrowth across time points. At baseline, the patient had a SALT Score of 100, and at Week 36, a SALT Score of 8. There is a description above the images indicating that patient hairstyles may influence the appearance of SALT scores depicted.
Image footnote:
Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.a
**Caption:**
\[footnotes\]
aBased on the pooled post-hoc, placebo-controlled analysis of patients who achieved the primary endpoint (SALT score ≤20 at week 36) in BRAVE-AA1 and BRAVE-AA2, the observed mean SALT score at week 36 was 6.4 (SD: 6.5) among patients treated with Olumiant 4 mg/day (N=175).
The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.
See BRAVE-AA1 and BRAVE-AA2 trial designs.
\[abbreviations\]
SALT=Severity of Alopecia Tool; SD=standard deviation.
**06:52-06:56**
\[Title fades in from gradient background. A bar animated in from the side with three Olumiant branding colors\]
**Caption:**
\[title\]
Subgroup analysis
**06:56-07:27**
\[Dr. Mesinkovska appears on screen and then narrates while graphs appear and replace her on screen\]
**Caption:**
\[slide title\]
Earlier treatment with Olumiant (AA episode <4 years resulted in more patients achieving ≥80% scalp coverage)1,13
\[graph title\]
BRAVE-AA Trials (Pooled Results): SALT Score ≤20 Response Rates Through Week 52 Based on Duration of Current Episode in Patients with baseline SALT Score 50 to 94, NRI
**Descriptive Clue:**
SALT score ≤20 response rates based on duration of current AA episode in patients with a baseline SALT score 50 to 94 treated with Olumiant 2 mg/day through week 52.
At 36 weeks on Olumiant 2 mg/day, 39% of patients with an AA episode <4 years (N=105) achieved ≥80% scalp coverage compared to 17% of patients who had an AA episode ≥4 years (N=42). At 52 weeks, 41% of patients with an AA episode <4 years achieved ≥80% scalp coverage compared to 24% of patients who had an AA episode ≥4 years.
At 36 weeks on Olumiant 4 mg/day, 52% of patients with an AA episode <4 years (N=165) achieved ≥80% scalp coverage compared to 40% of patients who had an AA episode ≥4 years (N=83). At 52 weeks, 56% of patients with an AA episode <4 years achieved ≥80% scalp coverage compared to 41% of patients who had an AA episode ≥4 years.
**Caption:**
\[footnotes\]
The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response with 4 mg/day.
Data presented are from post-hoc, subgroup analyses; statistical conclusions cannot be made.
Data collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
See BRAVE-AA trial designs.
\[abbreviations\]
AA=alopecia areata; NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
**07:27-07:31**
\[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors\]
**Caption:**
\[title\]
Eyebrow and eyelash efficacy
**07:31-07:35**
\[Dr. Mesinkovska appears on screen speaking directly to the audience\]
**07:35-07:43**
\[Dr. Mesinkovska narrates while a stylized eye and eyebrow and table appear on screen\]
**Caption:**
\[slide title\]
With Oluminant 4 mg/day, an improvement in eyebrow and eyelash coverage was observed at week 361,4,5,14-16,\*
\[figure title\]
Percentage of Patients Who Achieved EB ClinROTM 0,1 or EL ClinROTM 0,1 With ≥2-Point Improvement From Baseline at Week 36, NRI†
**Descriptive Clue:**
An image of an eyebrow above an eye appears on the left side of the screen. There is a description at the top to indicate the results presented below are shown for patients with substantial eyebrow and eyelash hair loss at baseline. There is a table to the right, anchored to the eyebrow, that reads:
BRAVE-AA1: 31% of patients on Olumiant 4 mg/day (59/188 patients) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (4/124 patients) (p≤0.05)
BRAVE-AA2: 35% of patients on Olumiant 4 mg/day (56/161 patients) achieved EB ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 4% on placebo (5/112 patients) (p≤0.05)
There is a table to the right, anchored to the eye, that reads:
BRAVE-AA1: 34% of patients on Olumiant 4 mg/day (56/167 patients) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 3% on placebo (3/96 patients) (p≤0.05)
BRAVE-AA2: 34% of patients on Olumiant 4 mg/day (48/140 patients) achieved EL ClinRO 0,1 with ≥2-point improvement from baseline at week 36 vs 6% on placebo (5/90 patients) (p≤0.05)
**Caption:**
\[footnotes\]
\*The EB ClinRO and EL ClinRO are 4-point scales measuring eyebrow and eyelash hair loss, respectively, ranging from 0 (EB ClinRO: Full eyebrow coverage and no areas of eyebrow hair loss; EL ClinRO: Continuous eyelash line along both eyelids) to 3 (EB ClinRO: No notable eyebrow; EL ClinRO: No notable eyelashes). The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.
†Data collected after permanent study drug discontinuation or data collected at remote visits due to the COVID-19 pandemic were excluded.
‡p≤0.05 vs placebo.
\[abbreviations\]
EB ClinRO= Clinician-Reported Outcome Measure for Eyebrow Hair Loss; EL ClinRO= Clinician-Reported Outcome Measure for Eyelash Hair Loss; NRI=nonresponder imputation.
**07:43-07:54**
\[Previous images are replaced by an iconized image of a half face and statistics\]
**Caption:**
\[slide title\]
Demonstrated improvement in scalp, eyebrow, and eyelash coverage through week 521,4,7,8,14-16
\[image title\]
BRAVE-AA Trials (Pooled Results): Proportion of Patients on Olumiant Who Achieved a Response at Week 52, NRIa
**Descriptive Clue:**
An iconized image of half a face appears on the left side with four statistics anchored to the icon: 2 to the scalp region, one to the eyebrow region, and one to the eyelash region. The statistics show scalp hair loss: 22.6% achieved SALT score ≤20 at week 52 with Olumiant 2 mg/day (N=340), scalp hair loss: 39% achieved SALT score ≤20 at week 52 with Olumiant 4 mg/day (N=515), eyebrow hair loss: 44.1% achieved EB ClinRO 0,1 with a ≥2-point improvement at week 52 with Olumiant 4 mg/day (N=349)b, eyelash hair loss: 45.3% achieved EL ClinRO 0,1 with a ≥2-point improvement at week 52 with Olumiant 4 mg/day (N=307)b
**Caption:**
\[footnotes\]
The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response with 4 mg/day.
In BRAVE-AA trials, the primary endpoint was the proportion of patients achieving a SALT score ≤20 at week 36. These prespecified analyses included patients randomized to Olumiant 2 mg/day or 4 mg/day at baseline who remained on their dosage through week 52. Data after week 36 were not placebo-controlled.
aData collected after permanent study drug discontinuation or at remote visits due to the COVID-19 pandemic were excluded.
bThe EB ClinRO and EL ClinRO are 4-point scales measuring eyebrow and eyelash hair loss, respectively, ranging from 0 (EB ClinRO: Full eyebrow coverage and no areas of eyebrow hair loss; EL ClinRO: Continuous eyelash line along both eyelids) to 3 (EB ClinRO: No notable eyebrow; EL ClinRO: No notable eyelashes). The ClinRO measures were developed following psychometric validation techniques but with limited data on content validity and interrater reliability. Both eyebrows and both eyelashes were evaluated together, not individually. This information should be taken into consideration when evaluating these data.
See BRAVE-AA trial designs.
\[abbreviations\]
EB ClinRO= Clinician-Reported Outcome Measure for Eyebrow Hair Loss; EL ClinRO= Clinician-Reported Outcome Measure for Eyelash Hair Loss; SALT=Severity of Alopecia Tool.
**07:54-07:58**
\[Dr. Mesinkovska appears on screen as title fades in\]
**Caption:**
\[title\]
See the difference Olumiant can make in your adult patients with severe AA
**07:58-08:10**
**ACTION:**
Patient photos build on screen.
**Caption:**
\[title\]
See the difference Olumiant can make through week 361,10-12,14
**Descriptive Clue:**
Images of a patient's eyebrow regrowth from baseline to week 36 show an improvement in EB ClinRO from 3 to 1, and images of a different patient's eyelash regrowth from baseline to week 36 show an improvement in EL ClinRO from 3 to 1. There is a description above indicating how the ClinRO™ measures were developed.
**Caption:**
\[disclaimer\]
Clinical trial patient treated with Olumiant 4 mg/day for 36 weeks. Individual results may vary.
**08:10-08:14**
\[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors\]
**Caption:**
\[title\]
When can patients expect hair regrowth?
**08:14-08:44**
\[Dr. Mesinkovska appears on the left side of the screen as a schematic shows early, gradual, and late responders\]
**Caption:**
\[title\]
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Onset of Improvement Groups
**Descriptive Clue:**
Early responders are defined as those who responded ≤12 weeks, gradual responders: >12 weeks to ≤36 weeks, and late responders: >36 to 52 weeks.
**08:44-09:00**
\[Onset of improvement graphic and text transitions to full screen and continues to build on\]
**Caption:**
\[title\]
Onset of improvement (≥30% regrowth) within 1 year is driven by baseline severity17
\[schematic title\]
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Onset of Improvement Groups
**Descriptive**
There is a description above the schematic to indicate that patients were categorized as improvers or non-improvers based on the achievement of >30% improvement in SALT score at any point within 1 year of treatment. Early responders are defined as those who responded ≤12 weeks, gradual responders: >12 weeks to ≤36 weeks, and late responders: >36 to 52 weeks. Patients with a baseline severity 50-94 were more likely to be early improvers.\* Patients with a baseline severity 95-100 were more likely to be gradual or late improvers.\*
**Caption**
\[footnotes\]
Data presented are from post-hoc, subgroup analyses; statistical conclusions cannot be made.
\*Early improvers were more likely to have less severe SALT scores at baseline. Olumiant 2 mg: 81% of early responders had a SALT score 50-94 at baseline compared to 44% and 34% of gradual and late improvers, respectively. Olumiant 4 mg: 73% of early responders had a SALT score 50-94 at baseline compared to 47% and 34% of gradual and late improvers, respectively.
On Olumiant 2 mg, 51% (174/340) of patients were improvers (20% early, 23% gradual, and 9% late).
On Olumiant 4 mg, 69% (355/515) were improvers (33% early, 28% gradual, 8% late).
\[abbreviations\]
AA=alopecia areata, SALT=Severity of Alopecia Tool.
**09:00-09:15**
**Caption:**
\[slide title\]
Onset of improvement may indicate the likelihood of achieving 80% or more scalp hair coverage by 1 year17,18
\[graph title\]
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Percent of Patients Achieving a SALT Score ≤20 Based on Timing of Onset of Improvement
**Descriptive Clue:**
A graph displaying Olumiant 2 mg group results appears. The graph shows that within the Olumiant 2 mg group (N=340), a SALT score <20 was reached by 70% (47/67) of early, 40% (31/78) of gradual, and 14% (4/29) of late improvers.
**Caption:**
\[footnotes\]
Data presented are from post-hoc, subgroup analyses; statistical conclusions cannot be made.
Onset of improvement was categorized based on timing of achievement of ≥30% improvement in SALT score within 1 year of treatment.
On Olumiant 2 mg (N=340), a SALT score <20 was reached by 70% (47/67) of early, 40% (31/78) of gradual, and 14% (4/29) of late improvers.
On Olumiant 4 mg (N=515), a SALT score <20 was reached by 78% (131/168) of early, 51% (75/146) of gradual, and 20% (8/41) of late improvers.
Early improvers were more likely to have less severe SALT scores at baseline. Olumiant 2 mg: 81% of early improvers had a SALT score 50-94 at baseline compared to 44% and 34% of gradual and late improvers, respectively. Olumiant 4 mg: 73% of early improvers had a SALT score 50-94 at baseline compared to 47% and 34% of gradual and late improvers, respectively.
\[abbreviations\]
SALT=Severity of Alopecia Tool.
**09:15-09:30**
**Caption:**
\[slide title\]
Onset of improvement may indicate the likelihood of achieving 80% or more scalp hair coverage by 1 year
\[graph title\]
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Percent of Patients Achieving a SALT Score ≤20 Based on Timing of Onset of Improvement
**Descriptive Clue:**
A graph displaying Olumiant 4 mg group results appears beside Olumiant 2 mg group. The graph shows that within the Olumiant 4 mg group (N=515), a SALT score <20 was reached by 78% (131/168) of early, 51% (75/146) of gradual, 20% (8/41) of late improvers.
**Caption:**
\[footnotes\]
Data presented are from post-hoc, subgroup analyses; statistical conclusions cannot be made.
Onset of improvement was categorized based on timing of achievement of ≥30% improvement in SALT score within 1 year of treatment.
On Olumiant 2 mg (N=340), a SALT score <20 was reached by 70% (47/67) of early, 40% (31/78) of gradual, and 14% (4/29) of late improvers.
On Olumiant 4 mg (N=515), a SALT score <20 was reached by 78% (131/168) of early, 51% (75/146) of gradual, 20% (8/41) of late improvers.
Early improvers were more likely to have less severe SALT scores at baseline. Olumiant 2 mg: 81% of early improvers had a SALT score 50-94 at baseline compared to 44% and 34% of gradual and late improvers, respectively. Olumiant 4 mg: 73% of early improvers had a SALT score 50-94 at baseline compared to 47% and 34% of gradual and late improvers, respectively.
\[abbreviations\]
SALT=Severity of Alopecia Tool.
**09:30-09:35**
\[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors\]
**Caption:**
\[title\]
What can patients expect with long-term treatment?
**09:35-09:50**
\[Dr. Mesinkovska appears on screen speaking directly to the audience\]
**09:50-10:00**
\[Dr. Mesinkovska stays on screen speaking directly to the audience\]
**Caption:**
\[title\]
BRAVE-AA1 and BRAVE-AA2: Long-term Extension Study Design19-21
**10:00-10:48**
**Caption:**
\[slide title\] Long-term extension study design: responders (SALT score ≤20) at week 52 were eligible for re-randomization19,\*
\[figure title\]
BRAVE-AA1 and BRAVE-AA2: Long-term Extension Study Design19-21
**Descriptive Clue:**
A schematic indicating that participants who achieved a SALT score ≤20 at week 52 of BRAVE-AA1 and BRAVE-AA2 were re-randomized to receive a placebo, 2 mg/day, or 4 mg/day up to 104 weeks for a long-term extension. Participants were either withdrawing with placebo, maintaining or down-titrating to 2 mg/day, or maintaining 4 mg/day, according to their prior randomization.
**Caption:**
\[footnotes\]
The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day once patients achieve an adequate response with 4 mg/day.
\*Sub-study eligible responders (SALT score ≤20) were re-randomized. Patients randomized to placebo at baseline, rescued to Olumiant at week 36, and had a SALT score ≤20 at week 52 were not eligible for re-randomization.19,20
†In BRAVE-AA2, patients randomized to Olumiant 2 mg QD at baseline and had a SALT score ≤20 at week 52 remained on their same dose.
\[abbreviations\]
PBO=placebo; QD=once daily; SALT=Severity of Alopecia Tool.
**10:48-10:53**
\[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors\]
**Caption:**
\[title\]
What happened to scalp coverage for patients who continued treatment through 3 years?
**10:53-10:58**
\[Dr. Mesinkovska appears on screen\]
**10:58-11:16**
**Caption:**
\[graph title\]
BRAVE-AA Trials (Pooled Results): Percentage of Responders Who Sustained a SALT Score ≤20 Through Week 152, LOCFa
**Descriptive Clue:**
The graph indicates that BRAVE-AA1 and BRAVE-AA2 (Pooled Results) showed 84% of responders on Olumiant 2 mg/day (N=67) and 89% of responders on Olumiant 4 mg/day (N=129) sustained a SALT score ≤20 from week 52 to week 152.
91% of responders on Olumiant 2 mg/day (N=67) and 88% of responders on Olumiant 4 mg/day (N=129) sustained a SALT score ≤20 from week 52 to week 104.
**Caption:**
\[footnotes\]
The recommended dosage is 2 mg/day. Increase to 4 mg/day if response is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider 4 mg/day. Decrease to 2 mg/day when an adequate response has been achieved.
Study Design: In the BRAVE-AA trials, patients randomized to Olumiant 4 mg or 2 mg remained on treatment until week 52. At week 52, responders (SALT score ≤20; N=278) were re-randomized to either: treatment continuation (both trials), withdrawal to placebo (BRAVE-AA1) or down-titration from 4 mg to 2 mg (BRAVE-AA2).
Down-Titration Efficacy: In BRAVE-AA2, 59% of patients (N=42) on Olumiant who achieved a SALT score ≤20 at week 52 sustained ≥80% scalp coverage through week 152 when their dose was reduced from Olumiant 4 mg/day to 2 mg/day.
\*,aLOCF analysis excludes study drug discontinuation or dose change after week 52.
The long-term extension data of BRAVE-AA trials were not placebo-controlled.
\[abbreviations\]
LOCF=last observation carried forward; SALT=Severity of Alopecia Tool.
**11:16-11:20**
\[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors\]
**Caption:**
\[title\]
What happened when patients increased their dose?
**11:21-11:27**
\[Dr. Mesinkovska appears on screen and speaks directly to the audience\]
**11:28-11:39**
**Caption:**
\[page title\]
Up-titration: SALT score ≤20 response rates after increasing the treatment dose for nonresponders23
\[graph title\]
BRAVE-AA1 and BRAVE-AA2 Up-titration Period (Pooled analysis): Percentage of Patients Who Achieved a SALT Score ≤20 (Week 52 to 76), NRI23,\*
**Descriptive Clue:**
Among patients on Olumiant 2 mg/day who were non-responders at week 52, 3%, 13%, and 26% achieved a SALT score ≤20 at week 56, 64, and 76, respectively, after the treatment dose was increased to Olumiant 4 mg/day (N=212).
**Caption:**
\[footnotes\]
In patients receiving treatment with 4 mg/day, decrease the dosage to 2 mg/day once patients achieve an adequate response.1
Eligible nonresponders (SALT score >20) in the Olumiant 2 mg/day treatment arm were transitioned to Olumiant 4 mg/day at week 52 and continue through week 76.23
\*Excludes data collected after permanent study drug discontinuation.23
The long-term extension data of BRAVE-AA1 and BRAVE-AA2 were not placebo-controlled.19,20
\[abbreviations\]
NRI=nonresponder imputation; SALT=Severity of Alopecia Tool.
**11:39-11:43**
\[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors\]
**Caption:**
\[title\]
What happened when patients decreased their dose?
**11:43-11:49**
\[Cut to close up of Dr. Mesinkovska\]
**11:49-11:59**
**Caption:**
\[graph title\]
BRAVE-AA2 Down-Titration Period (Weeks 52-152): Percentage of Responders Who Sustained a SALT Score ≤20, LOCF\*
**Descriptive Clue:**
There is a description above the graph to indicate that 59% of patients (N=42) on Olumiant who achieved a SALT score ≤20 at week 52 sustained >80% scalp coverage through week 152 when their dose was reduced from Olumiant 4 mg/day to 2 mg/day, LOCF.\*
The graph indicates that within BRAVE-AA2, 66% of responders (N=42) sustained a SALT score ≤20 when their dose was reduced from Olumiant 4 mg/day to 2 mg/day up to week 104 and 59% sustained a SALT score ≤20 at week 152.
**Caption:**
\[footnotes\]
In patients receiving treatment with 4 mg/day, decrease the dosage to 2 mg/day once patients achieve an adequate response.
Patients randomized to Olumiant 4 mg or 2 mg remained on treatment until week 52, and then responders (SALT score ≤20) on Olumiant 4 mg (N=85) either continued treatment or down-titrated to 2 mg.
\*LOCF excludes study drug discontinuation or dose change after week 52.
The long-term extension data of BRAVE-AA2 were not placebo-controlled.
\[abbreviations\]
LOCF=last observation carried forward; SALT=Severity of Alopecia Tool.
**11:59-12:04**
\[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors\]
**Caption:**
\[title\]
What happened when patients discontinued treatment?
**12:04-12:17**
**Caption:**
\[graph title\]
BRAVE-AA1: Percentage of Responders Who Sustained a SALT Score ≤20 From Week 52 to Week 104 After Discontinuing Treatment, MI+NRIa
**Descriptive Clue:**
The graph shows that in BRAVE-AA1, 10% of responders who switched from 2 mg/day to placebo (N=10) and 20% of responders who switched from 4 mg/day to placebo (N=30) sustained a SALT score ≤20 from week 52 to week 104.
**Caption:**
\[footnotes\]
\*,aMI+NRI analysis excludes data after permanent study drug discontinuation, treatment switch after week 52 visit, or collected at remote visits due to the COVID-19 pandemic. Missing data due to COVID-19 were imputed by MI; data missing for other reasons were imputed as nonresponse.
These analyses included BRAVE-AA1 responders (SALT score ≤20) at week 52 who were randomized from Olumiant 2 mg/day and Olumiant 4 mg/day to placebo withdrawal.
The study population sample size should be taken into consideration when evaluating these data.
See BRAVE-AA1 Long-Term Extension study design.
**12:17-12:21**
\[Dr. Mesinkovska appears on screen speaking directly to the audience\]
**12:21-12:25**
\[Title fades in from gradient background. A bar animates in from the side with three Olumiant branding colors\]
**Caption:**
\[title\]
Summary
**12:25-12:40**
**Caption:**
\[title\]
Olumiant offers the possibility of complete or near-complete hair regrowth that is sustained with an established safety profile in a once-daily tablet1,6,7,19-22
**Descriptive Clue:**
There is an icon of a hair follicle to represent complete or near-complete hair regrowth. Olumiant has been proven to help patients achieve ≥80% scalp coverage by week 36.
There is an icon of a calendar and an arrow around a checkmark to indicate sustained efficacy. Among responders (≥80% scalp coverage) at 1 year, most sustained the response through 3 years with Olumiant treatment.
**12:40-12:47**
\[Dr. Mesinkovska appears on the left side of the screen and claim transitions to inset\]
**Caption:**
\[title\]
Olumiant offers the possibility of complete or near-complete hair regrowth that is sustained with an established safety profile in a once-daily tablet1,6,7,19-22
**Descriptive Clue:**
There is an icon of a hair follicle to represent complete or near-complete hair regrowth. Olumiant has been proven to help patients achieve ≥80% scalp coverage by week 36.
There is an icon of a calendar and an arrow around a checkmark to indicate sustained efficacy. Among responders (≥80% scalp coverage) at 1 year, most sustained the response through 3 years.
**12:48-12:53**
\[SSI appears on screen\]
**Caption:**
\[title\]
SELECT SAFETY INFORMATION
\[copy\]
Olumiant has a Boxed Warning for serious infetions, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. Consider the risks and beenfits of treatment prior to initiating or continuing therapy with Olumiant. In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
**12:53-13:00**
\[Dr. Mesinkovska appears on screen speaking directly to the audience to provide closing remarks\]
**13:01-13:05**
\[Dr. Mesinkovska’s conflict of interest statement appears\]
**Caption:**
\[copy\]
Dr. Natasha Mesinkovska, MD., PhD., is a speaker for Eli Lilly and Pfizer. She is a member of the Advisory Board for Eli Lilly, Pfizer, Sun Pharma, Abbvie, L'Oréal, and Nutrafol.
**13:05-15:45**
\[Dr. Mesinkovska’s conflict of interest statement is replaced with the ISI for Olumiant (baricitinib) tablets. The ISI scrolls slowly through the remaining ISI details\]
**Caption:**
\[title\]
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets
\[copy\]
Serious hypersensitivity reactions, gastrointestinal perforations, and laboratory abnormalities have been reported in Olumiant-treated patients.
Discontinue Olumiant if a serious hypersensitivity reaction occurs while evaluating the potential causes.
Monitor patients who may be at increased risk for gastrointestinal perforations. Promptly evaluate those presenting with new onset abdominal symptoms.
Avoid initiation or interrupt treatment in patients with an absolute neutrophil count (ANC) <1000 cells/mm3, absolute lymphocyte count (ALC) <500 cells/mm3, or hemoglobin level <8 g/dL.
If liver enzyme elevation (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]) is observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
Assess lipid parameters approximately 12 weeks following Olumiant initiation and manage patients according to clinical hyperlipidemia guidelines.
Avoid use of live vaccines with Olumiant. Update immunizations prior to initiating therapy.
Most common adverse reactions in alopecia areata trials (≥1%) were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
Advise pregnant women and women of reproductive potential of the potential risk of fetal harm. Advise women not to breastfeed during Olumiant treatment and for 4 days after the last dose.
Olumiant is not recommended in patients with severe hepatic or severe renal impairment.
This is not the complete safety information for Olumiant. For additional information, please see the full Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, and Major Adverse Cardiovascular Events, and Thrombosis, and the full Prescribing Information on this site.
\[footnote\]
BA HCP MSR AA 13JUN2022
**15:45-15:53**
\[References appear on screen\]
**Caption:**
\[title\]
References
01. Olumiant. Prescribing Information. Lilly USA, LLC.
02. Olsen EA, Hordinsky MK, Price VH, et al. Alopecia areata investigational assessment guidelines-part II. _J Am Acad Dermatol_. 2004;51(3):440-447.
03. Data on file. Lilly USA, LLC. DOF-BA-US-0065.
04. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. _N Engl J Med_. 2022;386(18):1687-1699.
05. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. _N Engl J Med_. 2022;386(suppl 1):1-77.
06. Data on file. Lilly USA, LLC. DOF-BA-US-0075.
07. Data on file. Lilly USA, LLC. DOF-BA-US-0076.
08. Data on file. Lilly USA, LLC. DOF-BA-US-0074.
09. Data on file. Lilly USA, LLC. DOF-BA-US-0122.
10. Data on file. Lilly USA, LLC. DOF-BA-US-0084.
11. Data on file. Lilly USA, LLC. DOF-BA-US-0086.
12. Data on file. Lilly USA, LLC. DOF-BA-US-0092.
13. Data on file. Lilly USA, LLC. DOF-BA-US-0117.
14. Wyrwich K, Kitchen H, Knight S, et al. Development of clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) measures for eyebrow, eyelash and nail assessment in alopecia areata. _Am J Clin Dermatol_. 2020;21(5):725-732.
15. Data on file. Lilly USA, LLC. DOF-BA-US-0063.
16. Data on file. Lilly USA, LLC. DOF-BA-US-0064.
17. King B, Shapiro J, Ohyama M, et al. When to expect scalp hair regrowth during treatment of severe alopecia areata with baricitinib: insights from trajectories analyses of patients enrolled in two phase III trials. _Br J Dermatol_. 2023;189(6):666-673.
18. Data on file. Lilly USA, LLC. DOF-BA-US-0121.
19. Data on file. Lilly USA, LLC. DOF-BA-US-0078.
20. Data on file. Lilly USA, LLC. DOF-BA-US-0090.
21. Data on file. Lilly USA, LLC. DOF-BA-US-0105.
22. Data on file. Lilly USA, LLC. DOF-BA-US-0111.
23. Data on file. Lilly USA, LLC. DOF-BA-US-0102.
24. Data on file. Lilly USA, LLC. DOF-BA-US-0101.
25. Data on file. Lilly USA, LLC. DOF-BA-US-0100.
**15:53-15:54**
\[The Eli Lilly logo and disclaimers appear on a white background\]
**Caption:**
Lilly logo and Veeva code.
PP-BA-US-2331 10/2024 ©Lilly USA, LLC 2024. All rights reserved.
ClinRO Measure for Eyebrow Hair Loss™ and ClinRO Measure for Eyelash Hair Loss™ are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Olumiant® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.
Safety Profile and treatment considerations with Olumiant
Featuring Omer Ibrahim, MD, FAAD
Up
Transcript
**00:00-00:03**
\[Olumiant logo, video title, and disclaimer appear on screen. The disclaimer and logo remain visible for the duration of the video.\]
**Descriptive Clue:**
The Olumiant logo includes the text Olumiant (baricitinib) tablets 4 mg, 2 mg, 1 mg
**Caption:**
\[Title\]
SAFETY PROFILE AND TREATMENT CONSIDERATIONS WITH OLUMIANT
**Caption:**
\[Disclaimer footer\]
Please see Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis and full Prescribing Information on the site.
**00:04-00:27**
\[Indication and limitations of use appear on screen.\]
**Caption:**
Video to begin after brief Safety Information.
**INDICATION:**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata.1
**LIMITATIONS OF USE:**
Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.1
**00:28-02:06**
\[Warning information appears on screen.\]
**Caption:**
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS.
Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; treat latent TB prior to use.
Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.
Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.
Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.
Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.
**02:07-02:09**
\[Dr. Omer Ibrahim’s credential information appears on screen.\]
**Caption:**
Dr. Omer Ibrahim is a Co-director of Chicago Cosmetic and Dermatologic Research. He has published numerous peer-reviewed articles, book chapters, and editorials on general, surgical, and cosmetic dermatology. Dr. Ibrahim has participated in numerous research trials covering topics ranging from hair loss to innovative laser anti-aging treatments. He serves as an adjunct faculty at Cleveland Clinic, Chicago, where he teaches residents the fundamentals of cosmetic dermatology.
**02:10-02:21**
\[Dr. Ibrahim appears on screen with credentials animating below him. He introduces himself and the video.\]
**Caption:**
Dr. Omer Ibrahim
MD, FAAD, Co-director of Research, Chicago Cosmetic Surgery and Dermatology, Clinical Instructor, RUSH University Medical Center
**02:22-02:25**
\[Dr. Ibrahim disappears, and section title appears on screen.\]
**Caption:**
How many patients have experience on Olumiant?
**02:26-02:35**
\[Dr. Ibrahim appears on screen and speaks directly to the viewer.\]
**02:36-02:55**
\[Dr. Ibrahim disappears, and patient exposure data appears on screen.\]
\[On all claim-related screens, there is an eyebrow on top left in orange color: “FOR ADULTS WITH SEVERE ALOPECIA AREATA”\]
**Caption:**
\[Figure title\]
Extensive Patient Exposure Over 9 Years1-4\*
**Descriptive Clue:**
Olumiant has been well studied and is approved across two immunologic diseases, rheumatoid arthritis (2018) and alopecia areata (2022).
Unrivaled total exposure in adults with severe AA across clinical trials and real-world use. 1,303 patients have been treated with Olumiant for up to 4 years in the AA clinical trial program.a Post-approval: Over 11,000 patients have been treated with Olumiant.b
**Caption:**
\[Footer\]
\*Exposure in adults: RA over 9 years and AA up to 4 years.
aAs of May 2023, median exposure of 825 days and maximum exposure of 4.0 years across two randomized AA clinical trials (N=1,303).
bData cutoff was 04/2024.
AA=alopecia areata; RA=rheumatoid arthritis.
**02:56-03:06**
\[Alopecia areata and rheumatoid arthritis indications and limitations of use appear on screen side by side.\]
**Caption:**
\[Figure Title\]
**Alopecia Areata**
Indication:
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata.1
Limitations of use:
Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.1
\[Figure Title\]
**Rheumatoid Arthritis**
Indication:
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.1
Limitations of use:
Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.1
**03:07-03:10**
\[Section title appears on screen.\]
**Caption:**
What is the safety profile of Olumiant, including long-term safety?
**03:11-03:33**
\[Camera angle changes back to front-facing angle as Dr. Ibrahim continues speaking and introduces the next section.\]
**03:34-03:38**
\[Dr. Ibrahim disappears, and section title appears on screen.\]
**Caption:**
What key safety results were reported in clinical trials?
**03:39-03:41**
\[Dr. Ibrahim appears on screen.\]
**03:41-04:04**
\[Dr. Ibrahim disappears while continuing to speak, and adverse reactions table appears on screen. Adverse events and data values scroll in time with voice-over.\]
**Caption:**
\[Table title\]
Adverse reactions (≥1%) through week 361
**Descriptive Clue:**
The table starts scrolling. Across the top is the description that is BRAVE-AA1 and BRAVE-AA2 (Pooled Results): Adverse Reactions That Occurred in ≥1% of Patients on Olumiant and More Frequently Than Placebo Over a 36-Week Period.\* In order, the three columns list Placebo (N=371), Olumiant 2 mg/day (N=365), and Olumiant 4 mg/day (N=540).
Upper respiratory tract infections† seen in 19.9%, 18.4%, 21.3%.
Headache seen in 5.4%, 5.5%, 6.6%.
Acne‡ seen in 2.2%, 5.8%, 5.9%.
Hyperlipidemia§ seen in 3.0%, 3.6%, 5.9%.
Blood creatine phosphokinase increased seen in 1.3%, 0.8%, 4.3%.
Urinary tract infections‖ seen in 2.2%, 3.8%, 3.7%.
Liver enzyme elevations¶ seen in 2.4%, 1.1%, 3.0%.
Folliculitis# seen in 0.8%, 1.4%, 2.2%.
Fatigue seen in 1.1%, 0.8%, 2.2%.
Lower respiratory tract infections\*\* seen in 0.8%, 2.2%, 2.0%.
Nausea seen in 1.6%, 2.7%, 2.0%.
Genital Candida infections†† seen in 0.3%, 2.2%, 1.3%.
Anemia seen in 0.3%, 0.3%, 1.3%.
Neutropenia‡‡ seen in 0.8%, 0.3%, 1.3%.
Abdominal pain§§ seen in 2.2%, 3.8%, 0.9%.
Herpes zoster seen in 0.5%, 1.4%, 0.9%.
Weight increased seen in 0.3%, 1.6%, 0.9%.
**Caption:**
\[Footer\]
\*%-study size adjusted percentages.
†Includes acute sinusitis, influenza, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, upper respiratory tract infection, viral upper respiratory tract infection, viral sinusitis, viral pharyngitis, respiratory tract infection viral, rhinovirus infection, and adenoiditis.
‡Includes acne and dermatitis acneiform.
§Includes hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, dyslipidemia, lipids increased, low density lipoprotein increased, blood cholesterol increased, and blood triglycerides increased.
‖Includes cystitis, urinary tract infection, white blood cells urine positive, urinary tract infection bacterial, and pyelonephritis.
¶Includes transaminases increased, aspartate aminotransferase increased, alanine aminotransferase increased, hepatic enzyme increased, gamma-glutamyl transferase increased, and hepatic function abnormal.
#Was most commonly localized in the scalp region associated with hair regrowth.
\*\*Includes bronchitis, bronchiolitis, lower respiratory tract infection, pneumonia, COVID-19 pneumonia, and respiratory tract infection.
††Includes vulvovaginal candidiasis, vulvovaginal mycotic infection, and genital infection fungal.
‡‡Includes neutropenia and neutrophil count decreased.
§§Includes abdominal pain, abdominal pain lower, abdominal pain upper, and abdominal discomfort.
**04:05-04:08**
\[Section title appears on screen.\]
**Caption:**
What are the 3-year safety results?
**04:09-04:14**
\[Dr. Ibrahim appears on screen introducing the section.\]
**04:15-05:00**
\[Dr. Ibrahim disappears while continuing to speak, and adverse events of special interest table appears on screen. Data is populated and/or emphasized in time with the voice-over.\]
**Caption:**
\[Table title\]
AEs of special interest: 3-year safety update5-11
**Descriptive Clue:**
BRAVE-AA1 and BRAVE-AA2 (Pooled Results): adverse events of Special Interest.\*
Table with 3 subsections. Column section one, from weeks 0-36, during the placebo-controlled period, shows the adverse events experienced by the 371 patients given placebo, 365 patients given Olumiant 2 mg/day, and 540 patients given Olumiant 4 mg/day. Serious infections were experienced by 2 patients (0.5%) in the Olumiant 2 mg/day group \[0.8\] and 1 patient (0.2%) in the Olumiant 4 mg/day group \[0.3\], but not by anyone in the placebo group. No one in the study experienced an opportunistic infection. One patient (0.3%) in the placebo group \[0.4\] and 1 patient in the Olumiant 4 mg/day group \[0.3\] experienced a malignancy other than NMSC.a No one reported NMSC. One patient (0.3%) in the Olumiant 2 mg/day group \[0.4\] experienced a MACE (adjudicated).b No one in the study reported DVT/PE (adjudicated). Column section two, from weeks 0-152, is titled Extended Safety Analysisb and measures n \[IR/100 PYE\] for Olumiant 2 mg/day (N=383 PYE=523.25) and Olumiant 4 mg/day (N=565; PYE=1106.70). Two patients in the 2 mg/day group \[0.4\] and six in the 4 mg/day group \[0.5\] experienced a serious infection. No opportunistic infections were reported. Three people in the 4 mg/day group \[0.3\] experienced a malignancy other than NMSC.a One person in the 2 mg/day group \[0.2\] were diagnosed with NMSC. One person in the 2 mg/day group \[0.2\] reported a MACE (adjudicated),b and one person in the 2 mg/day group \[0.2\] had a DVT/PE (adjudicated). Column section three is titled All BARI AAc and measures n \[IR/100 PYE\] for All Doses (N=1303; PYE=2789.69). 16 patients \[6.0\] experienced serious infection, one patient \[<0.1\] experienced opportunistic infections, 7 patients \[0.2\] experienced Malignancies other than NMSCa, three patients \[0.1\] were diagnosed with NMSC, one patient \[<0.1\] reported a MACE (adjudicated),b and two patients \[0.1\]d had a DVT/PE (adjudicated).
**Caption:**
\[Footer\]
\*Data includes patients from the BRAVE-AA1 (Phase 2/3) and BRAVE-AA2 (Phase 3) trials, and from a study addendum.
aAll BARI includes the events of prostate cancer (placebo), B-cell lymphoma (Olumiant 4 mg/day), breast cancers (Olumiant 4 mg/day & 2 mg/day), chronic lymphocytic leukemia (Olumiant 2 mg/day), malignant melanoma in situ (Olumiant 2 mg/day), malignant melanoma (Olumiant 4 mg/day), and endometrial cancer (Olumiant 4 mg/day).
bThe extended safety analysis includes patients who were treated continuously on either Olumiant 2 mg/day or 4 mg/day from randomization through data cut-off. Data is censored after any dose or treatment change.
cAll BARI AA includes all patients who received a dose of baricitinib at any time during the BRAVE-AA studies. Median exposure for All BARI AA was 825 days.
dOne patient had a DVT and one patient had a DVT/PE.
Certain adverse events, such as MACE and malignancy, require longer observation periods to ascertain risk.
Patients with high risk of DVT/PE, significant cardiac history, current or recent serious infection, or malignancy within 5 years were excluded from clinical trials.
Data cut-off dates for BRAVE-AA trials from weeks 0-36 by February 2021, weeks 0-152 by May 2023.
BARI=baricitinib; DVT=deep vein thrombosis; IR=incidence rate; MACE=major adverse cardiovascular event; NMSC=nonmelanoma skin cancer; PE=pulmonary embolism; PYE=patient years of exposure.
**05:01-05:04**
\[Section title appears on screen.\]
**Caption:**
What were adverse event rates in patients with and without risk factors?
**05:05-05:28**
\[Claim headers and required text build with the 46.0% statistic and outer circle. Surrounding data then build sequentially in time with the voice-over.\]
**Caption:**
\[Figure title\]
Proportion of patients with risk factors for select AEs of special interest at baseline5,12,13
**Descriptive Clue:**
About 46% of patients with severe AA had at least one risk factor for select AEs of special interest at baseline.\*
Circles of various sizes that scale proportionally to the percentage of patients with selected AEs are themselves placed in a circle around a statistic of at least one risk factor.
At least one risk factor: 46.0%
BMI ≥30 kg/m2: 20.4%
History of smokinga: 17.0%
Hypertension: 11.1%
HDL <40 mg/dL: 8.9%
Diabetes mellitus: 3.1%
History of malignancy: 1.3%
ASCVD: 0.9%
Age ≥65 yearsb: 2.5%
Severe mobility impairment (EQ-5D)c: 0.3%
Unrivaled total exposure in adults with severe AA across clinical trials and real-world use. 1,303 patients have been treated with Olumiant for up to 4 years in the AA clinical trial program.a Post-approval: Over 11,000 patients have been treated with Olumiant.b
Caption:
\[Footer\]
AEs of special interest included MACE, malignancies, VTE, serious infections, and mortality.
Individual disease burden, risk factors, and response to treatment should be considered to make an informed decision for individual patients treated with Olumiant.
The risk factors presented are those relevant for the selected AEs of special interest and were assessed as part of an analysis to address questions on JAK inhibitor safety from the EMA.
\*In AA analysis set, data were pooled from BRAVE-AA1 (phase 2/3) and BRAVE-AA2 (phase 3), and all patients who were exposed to any Olumiant dose.
aCurrent or past smoking.
bThe age of participants in the AA clinical trials was limited to ≤60 years for men and ≤70 years for women to reduce concomitant androgenic alopecia.
cSevere mobility impairment indicated by a response of either “I have severe problems in walking about” or “I am unable to walk about.”
AA=alopecia areata; AE=adverse event; ASCVD=atherosclerotic cardiovascular disease; BMI=body mass index; EMA=European Medicines Agency; EQ-5D=EuroQol-5 Dimension; HDL=high-density lipoprotein; JAK=Janus kinase; MACE=major adverse cardiovascular event; VTE=venous thromboembolism.
**05:29-05:33**
\[Dr. Ibrahim appears on screen introducing the next safety table.\]
**05:34-05:50**
\[Dr. Ibrahim disappears. Table with illustrations and required text build initially. Data points populate in time with voice-over.\]
**Caption:**
\[Figure title\]
An integrated safety analysis across BRAVE-AA clinical trials12,13
**Descriptive Clue:**
Incidence rates of adverse events of special interest in patients with and without specified risk factors\* in BRAVE-AA Clinical Trials.a Two columns, No specified risk factors (N=704) and ≥1 specified risk factor (N=599), measured in IR/100 PYE (n).
MACEb seen as 0 (0) and 0.12 (1).
Malignancies Excluding NMSCs seen as 0 (0) and 0.35 (3).
VTEc seen as 0 (0) and 0.12 (1).
Serious Infections seen as 0.57 (6) and 1.17 (10).
All-Cause Mortality seen as 0 (0) and 0 (0).
**Caption:**
\[Footer\]
\*The risk factors were ASCVD, diabetes mellitus, age ≥65 years, hypertension, history of smoking, HDL <40 mg/dL, BMI ≥30 kg/m2, severe mobility impairment as indicated by EQ-5D, or history of malignancy, also including factors only documented in case narrative, such as past smoking.
Individual disease burden, risk factors, and response to treatment should be considered to make informed decisions for individual patients treated with Olumiant.
aPooled data from BRAVE-AA1 and BRAVE-AA2 clinical trials. Total patient-years of exposure was 1868.
bMACE was defined as positively adjudicated events of myocardial infarction, stroke, and cardiovascular deaths combined.
cVTE was defined as DVT or PE.
AA=alopecia areata; AE=adverse event; ASCVD=atherosclerotic cardiovascular disease; BMI=body mass index; DVT=deep vein thrombosis; EQ-5D=EuroQol-5 Dimension; HDL=high-density lipoprotein; IR=incidence rate; MACE=major adverse cardiovascular event; NMSC= nonmelanoma skin cancer; PE=pulmonary embolism; PYE=patient years of exposure; VTE=venous thromboembolism.
**05:51-05:54**
\[Section title appears on screen.\]
**Caption:**
Which lab assessments are recommended for patients on Olumiant?
**05:55-06:02**
\[Dr. Ibrahim appears on screen in a medium shot.\]
**06:03-06:08**
\[Dr. Ibrahim appears in a close-up.\]
**06:09-07:26**
\[Dr. Ibrahim disappears. Table with lab assessment recommendations builds initially. Data points populate and are emphasized in time with voice-over.\]
**Caption:**
\[Table title\] Lab assessments and select treatment considerations with Olumiant1
**Descriptive Clue:**
Lab monitoring table that describes when to avoid initiation or interrupt treatment with Olumiant for the following lab parameters:
Lab results before treatment include: tuberculosis screening, hepatitis screeninga (active, serious, or opportunistic infection), complete blood count (CBC) with differential on absolute neutrophil count (ANC)b (<1000 cell/uL), absolute lymphocyte count (ALC)b (<500 cells/uL), and hemoglobin (Hgb)b (<8 g/uL), hepatic transaminases (ALT, AST)b (liver enzyme elevations and suspected drug-induced liver injury), glomerular filtration rate (GFR) (estimated GFR of less than 30 mL/min/1.73m3), evaluate for immunization screenings.d
Lab results at week 12: lipids.c
**Caption:**
\[Footer\]
Treatment can be initiated or restarted after ANC, ALC, or Hgb levels return above specified values, drug-induced liver injury diagnosis is excluded, or infection is controlled.
Laboratory Abnormalities - Treatment with Olumiant was associated with an increased risk of neutropenia (ANC <1000 cells/mm3). ALC <500 cells/mm3 and Hgb <8 g/dL were reported in Olumiant clinical trials. Treatment with Olumiant was associated with increased incidence of liver enzyme elevation. Increases of ALT ≥5 times the ULN and increases of AST ≥10 times the ULN were observed in patients taking Olumiant.
Treatment with Olumiant was also associated with increases in lipid parameters, including total cholesterol, LDL, and HDL.
Other Considerations During Routine Treatment:
Hepatic and Renal Impairment - Olumiant is not recommended for patients with severe renal or severe hepatic impairment. Dosage should be reduced in patients with moderate renal impairment.
Serious Infections - Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant.
Tuberculosis - If positive, treat for latent TB prior to Olumiant use. Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB prior to initiating therapy.
Viral Reactivation - If a patient develops herpes zoster, interrupt Olumiant treatment until episode resolves. Patients should be monitored for viral reactivation.
aPerform hepatitis screening in accordance with clinical guidelines.
bIn addition to evaluation before starting treatment, evaluate thereafter according to routine patient management.
cPatients should be managed according to clinical guidelines for hyperlipidemia.
dUpdate immunizations in agreement with current guidelines prior to initiating Olumiant.
ALC=absolute lymphocyte count; ALT=alanine aminotransferase; AST=aspartate aminotransferase; HDL=high-density lipoprotein; LDL=low-density lipoprotein; TB=tuberculosis; ULN=upper limit of normal.
**07:27-07:30**
\[Table fades off screen, and next section title appears.\]
**Caption:**
Summary
**07:31-07:37**
\[Dr. Ibrahim speaks directly to viewer.\]
**07:38-07:47**
\[Dr. Ibrahim appears in a close-up view with text emphasized on screen in time to voice-over.\]
**Caption:**
\[Visual title\]
Olumiant offers extensive exposure and an established, long-term safety profile1,3-7,14-18\*
**Descriptive Clue:**
Icon of a shield with the following bullets:
• 12,000+ severe AA patients have been treated with Olumiant†
• Safety profile established in 1,303 severe AA patients up to 4 years
**Caption:**
\[Footer\]
\*Data as of 04/2024
†12,000+ is inclusive of 1,303 (clinical trials) and 11,000+ (real-world use).
07:48-07:52
\[Dr. Ibrahim disappears and select safety information appears on screen.\]
**Caption:**
Select Safety Information
Olumiant has a Boxed Warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. Consider the risks and benefits of treatment prior to initiating or continuing therapy with Olumiant. In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
**07:53-07:59**
\[Dr. Ibrahim appears back on screen.\]
**08:00-08:03**
\[Dr. Ibrahim’s conflict of interest statement appears on screen.\]
**Caption:**
Dr. Omer Ibrahim is a consultant for Eli Lilly.
**08:04-10:43**
\[Additional safety information text appears on screen and is scrolled.\]
**Caption:**
ADDITIONAL SAFETY INFORMATION
Serious hypersensitivity reactions, gastrointestinal perforations, and laboratory abnormalities have been reported in Olumiant-treated patients.
Discontinue Olumiant if a serious hypersensitivity reaction occurs while evaluating the potential causes.
Monitor patients who may be at increased risk for gastrointestinal perforations. Promptly evaluate those presenting with new onset abdominal symptoms.
Avoid initiation or interrupt treatment in patients with an absolute neutrophil count (ANC) <1000 cells/mm3, absolute lymphocyte count (ALC) <500 cells/mm3, or hemoglobin level <8 g/dL.
If liver enzyme elevation (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]) is observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
Assess lipid parameters approximately 12 weeks following Olumiant initiation and manage patients according to clinical hyperlipidemia guidelines.
Avoid use of live vaccines with Olumiant. Update immunizations prior to initiating therapy.
Most common adverse reactions in alopecia areata trials (≥1%) were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
Advise pregnant women and women of reproductive potential of the potential risk of fetal harm. Advise women not to breastfeed during Olumiant treatment and for 4 days after the last dose.
Olumiant is not recommended in patients with severe hepatic or severe renal impairment.
**This is not the complete safety information for Olumiant. For additional information, please see the full Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, and Major Adverse Cardiovascular Events, and Thrombosis, and the full Prescribing Information on this site.**
BA HCP MSR AA 13JUN2022
**10:44-10:50**
**Caption:**
References
01. Olumiant. Prescribing Information. Lilly USA, LLC.
02. Taylor PC, Takeuchi T, Burmester GR, et al. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2021;81(3):335-343.
03. King B, Mostaghimi A, Shimomura Y, et al. Safety analysis of baricitinib in adult patients with severe alopecia areata from 2 randomized clinical trials over a median of 2.3 years and up to 4 years of exposure. Poster presented at the American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA. Abstract 51436.
04. Data on file. Lilly USA, LLC. DOF-BA-US-0118.
05. Data on file. Lilly USA, LLC. DOF-BA-US-0075.
06. Data on file. Lilly USA, LLC. DOF-BA-US-0090.
07. Data on file. Lilly USA, LLC. DOF-BA-US-0078.
08. Data on file. Lilly USA, LLC. DOF-BA-US-0094.
09. Data on file. Lilly USA, LLC. DOF-BA-US-0112.
10. Data on file. Lilly USA, LLC. DOF-BA-US-0113.
11. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. _N Engl J Med_. 2022;386(18):1687-1699.
12. Taylor PC, Bieber T, Alten R, et al. Baricitinib safety for events of special interest in populations at risk: analysis from randomised trial data across rheumatologic and dermatologic indications. _Adv Ther_. 2023;40(4):1867-1883.
13. Data on file. Lilly USA, LLC. DOF-BA-US-0116.
14. Data on file. Lilly USA, LLC. DOF-BA-US-0076.
15. Data on file. Lilly USA, LLC. DOF-BA-US-0105.
16. Data on file. Lilly USA, LLC. DOF-BA-US-0111.
17. Data on file. Lilly USA, LLC. DOF-BA-US-0095.
18. Data on file. Lilly USA, LLC. DOF-BA-US-0119.
**10:51-10:52**
\[Text fades to white. Lilly A MEDICINE COMPANY logo appears.\]
**Caption:**
Lilly logo and Veeva code.
PP-BA-US-2354 10/2024 ©Lilly USA, LLC 2024. All rights reserved.
## An Actual Patient Story
**Meet Laura**
## "There wasn't a day that went by that I didn't wish for my hair back."
_\- Laura, an actual patient with severe alopecia areata.\*_
**Watch Laura's journey with Olumiant below.**
\*Laura was compensated for her time. Individual results may vary.
* * *
[](https://olumiant.lilly.com/hcp/alopecia-areata/videos#)
Up
Transcript
0:00:00 - 1:24:20
Unknown
Having been a performing artist for almost my entire life, I spent so much time in the spotlight after I lost my hair. I didn't want people to look at me. My name is Laura. I was diagnosed with severe alopecia areata in 2008.
1:24:22 - 01:58:18
Unknown
As a performer, your hairstyle is part of the character that you play. I would put it up into a bun, usually for a classical role, or it would be free and flowing if I were doing a more contemporary dance. Not having that part of me and having that identity taken away was devastating. I remember distinctly being in bed one morning, rolling over and just laying on my arm and my hand randomly felt a perfectly bare, smooth spot of skin.
1:58:20 - 2:26:27
Unknown
I would be in the shower and clumps of hair would be falling out. I noticed a lot more hair than usual on my hairbrush, and I was scared. There was a lot of confusion. There was blaming myself. I didn't know what I did to cause this. I had lost all my eyebrows. I had lost all my eyelashes. So getting ready in the morning, not only would I have to, you know, put my bandana on and put my wig on, if I was getting dressed up.
2:26:29 - 2:52:02
Unknown
I would have to find solutions to also look like I had eyebrows and eyelashes. It was really time to come out of hiding, to share what was going on with me. And despite the fact of embracing who I was, there really wasn't a day that went by that I didn't wish for my hair back. I tried many different treatments.
2:52:04 - 3:00:03
Unknown
Nothing really gave me the result that I wanted.
3:00:06 - 3:24:17
Unknown
Once I had seen that halloumi it had been FDA approved for the treatment of severe alopecia areata in adults, I went to my dermatologist. I actually found out that I was going to be her first patient with alopecia areata that she would be treating with a Lumia. So I was very excited that we could learn together and we could see the possibilities of what a Lumia could do for me.
3:24:19 - 3:48:05
Unknown
I obtained my prescription in August of 2022, and that's when I began my whole limited journey. I've been taking a limit for a while now. I could feel some sprouts of eyebrows and eyelashes growing, and it's so amazing to have a hair again, to run my fingers through it, to feel it flowing in the breeze.
3:48:08 - 4:33:04
Unknown
Serious hypersensitivity reactions. Gastrointestinal perforations and laboratory abnormalities have been reported in the gloomiest treated patients. Discontinue illuminate if a serious hypersensitivity reaction occurs while evaluating the potential causes. Monitor patients who may be at increased risk for gastrointestinal perforations promptly evaluate those presenting with new onset abdominal symptoms. Avoid initiation or interrupt treatment in patients with an absolute neutrophil count or ANC less than 1000 cells per cubic millimeter absolute lymphocyte count or RLC less than 500 cells per cubic millimeter or hemoglobin level less than eight grams per deciliter.
4:33:07 - 5:06:0
Unknown
If liver enzyme elevation alanine aminotransferase or alt or aspartate aminotransferase or ast is observed and drug induced liver injury is suspected. Interrupt illuminates until this diagnosis is excluded, assess lipid parameters approximately 12 weeks following a lumi into initiation and manage patients according to clinical hyperlipidemia guidelines. Avoid use of live vaccines with illuminate. Update immunizations prior to initiating therapy.
5:06:03 - 5:43:06
Unknown
Most common adverse reactions in alopecia areata trials greater than or equal to 1% were upper respiratory tract infections, headache, acne hyperlipidemia creatine phosphate kinase increase urinary tract infections, liver enzyme elevations folliculitis fatigue, lower respiratory tract infections, nausea, genital candida infections, anemia, neutropenia, abdominal pain, herpes, zoster and weight increase. Advise pregnant women and women of reproductive potential of the potential risk of fetal harm.
5:43:08 - 6:19:04
Unknown
Advise women not to breastfeed during illuminated treatment and for four days after the last dose. Aluminum is not recommended in patients with severe hepatic or severe renal impairment. This is not the complete safety information for illuminate. For additional information, please see the full important safety information, including boxed warning about serious infections, mortality, malignancy and major adverse cardiovascular events and thrombosis and the full prescribing information on this site.
6:19:06 - 7:26:12
Unknown
I know that when people are looking at me, they're not seeing the thing that makes me stand out and makes me so different. They're seeing who are truly feel like I am.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant COVID-19 Access
[Skip to main content](https://olumiant.lilly.com/hcp/covid-19/access#maincontent)
# Access
Olumiant is FDA-approved for use in certain adults hospitalized with COVID-19 and available through Lilly's Authorized Specialty Distributors. To view a complete list,
[click here](https://olumiant.lilly.com/assets/pdf/authorized_distributor_of_record.pdf).
To view more information regarding reimbursement for Olumiant for COVID-19 treatment in the inpatient setting, [click here](https://olumiant.lilly.com/assets/pdf/reimbursement_resource.pdf).
**Product Information**
| Sales Package Size | NDC | UPC |
| --- | --- | --- |
| 1 mg X 30 tablets | NDC:
0002-4732-30 | UPC:
3-0002-4732-30-8 |
| 2 mg X 30 tablets | NDC:
0002-4182-30 | UPC:
3-0002-4182-30-1 |
| 4 mg X 30 tablets | NDC:
0002-4479-30 | UPC:
3-0002-4479-30-2 |
NDC=National Drug Code; UPC=Universal Product Code.
**References**
1. Olumiant. Prescribing information. Lilly USA, LLC.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant Dosing Guidelines
[Skip to main content](https://olumiant.lilly.com/hcp/covid-19/dosing-administration#maincontent)
# Dosage and Administration
Recommended Evaluations Prior to Treatment Initiation1
Prior to Olumiant treatment initiation, consider performing the following evaluations:
- Active and latent tuberculosis (TB) infection evaluation — Olumiant should not be given to patients with active tuberculosis (TB).
- Viral hepatitis screening in accordance with clinical guidelines.
- Complete blood count — Assess baseline values and verify whether treatment can be initiated:
- Olumiant initiation is not recommended if the ALC is <200 cells/µl or if the ANC is <500 cells/µl.
- Monitor complete blood counts during treatment and modify dosage as recommended.
- Baseline hepatic and renal function — Assess baseline values and monitor patients for laboratory changes. Modify dosage based on hepatic and renal impairment, and laboratory abnormalities.
Dosage Recommendations in COVID-191
The recommended dosage of Olumiant for adults is 4 mg once daily orally, with or without food, for 14 days or until hospital discharge, whichever occurs first. An alternative administration for patients unable to swallow tablets may be used. See "Alternative Administration" section.
Dosage Modifications Due to Infections and Cytopenias1
- Monitor patients for signs and symptoms of new infections during treatment with Olumiant. The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
- Dosage modifications for patients with COVID-19 and cytopenias are described in Table 1.
**Table 1: Dosage Modifications for Cytopenias in Patients with COVID-191**
| Laboratory Analyte | Laboratory Analyte Value | Recommendation |
| --- | --- | --- |
| Absolute Lymphocyte Count (ALC) | Laboratory Analyte Value:
≥200 cells/µL | Recommendation:
Maintain dosage |
| Laboratory Analyte Value:
<200 cells/µL | Recommendation:
Interrupt Olumiant until ALC ≥200 cells/µL |
| Absolute Neutrophil Count (ANC) | Laboratory Analyte Value:
≥500 cells/µL | Recommendation:
Maintain dosage |
| Laboratory Analyte Value:
<500 cells/µL | Recommendation:
Interrupt Olumiant until ANC ≥500 cells/µL |
Dosage Modifications for Patients with Renal Impairment or Hepatic Impairment1
_Renal Impairment_
- Dosage modifications for patients with COVID-19 and renal impairment are described in Table 2.
**Table 2: Dosage Modifications for Patients with COVID-19 and Renal Impairment1**
| Renal Impairment Stage | Estimated Glomerular Filtration Rate (eGFR) | Recommendation |
| --- | --- | --- |
| Renal Impairment Stage:
Mild | Estimated Glomerular Filtration Rate (eGFR):
60 - <90 mL/min/1.73m2 | Recommendation:
4 mg once daily |
| Renal Impairment Stage:
Moderate | Estimated Glomerular Filtration Rate (eGFR):
30 - <60 mL/min/1.73m2 | Recommendation:
2 mg once daily |
| Renal Impairment Stage:
Severe | Estimated Glomerular Filtration Rate (eGFR):
15 - <30 mL/min/1.73m2 | Recommendation:
1 mg once daily |
| Renal Impairment Stage:
End Stage Renal Disease, Patients on Dialysis, or Acute Kidney Injury | Estimated Glomerular Filtration Rate (eGFR):
<15 mL/min/1.73m2 | Recommendation:
Not recommended |
_Hepatic Impairment_
- It is not known if dosage adjustment is needed in patients with COVID-19 and severe hepatic impairment. Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk.
- Interrupt Olumiant, if increases in ALT or AST are observed and DILI is suspected, until the diagnosis of DILI is excluded.
ALT=alanine transaminase; AST=aspartate transaminase; DILI=Drug-induced liver injury.
Dosage Modifications Due to Drug Interactions1
The recommended dosages of Olumiant in patients with COVID-19 taking strong OAT3 inhibitors, such as probenecid, are shown in Table 3:
**Table 3: Dosage Modifications when Coadministered with Strong OAT3 Inhibitors in Patients With COVID-191**
| Concomitant Medication | Recommendation |
| --- | --- |
| Concomitant Medication:
Strong OAT3 inhibitors (e.g., probenecid) | Recommendation:
If the recommended dosage is 4 mg once daily, reduce dosage to 2 mg once daily. |
| Recommendation:
If the recommended dosage is 2 mg once daily, reduce dosage to 1 mg once daily. |
| Recommendation:
If the recommended dosage is 1 mg once daily, consider discontinuing probenecid. |
OAT3=Organic Anion Transporter 3.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO THROMBOSIS**
Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), was observed at an increased incidence in Olumiant-treated patients compared to patients treated with placebo. Arterial thrombosis events in the extremities have also reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers. If clinical features of DVT/PE or arterial thrombosis occur, discontinue Olumiant and promptly evaluate and appropriately treat patients. Avoid Olumiant in patients that may be at increased risk for thrombosis.
Alternative Administration
Alternative Administration for Patients Unable to Swallow Tablets1
For patients who are unable to swallow whole tablets, an alternative mode of administration may be considered:
- Oral dispersion
- Gastrostomy tube (G tube)
- Nasogastric tube (NG tube) or orogastric tube (OG tube)
Intact tablets are not hazardous. Tablets may be crushed to facilitate dispersion. It is not known if powder from the crushed tablets may constitute a reproductive hazard to the preparer. If tablets are crushed, use proper control measures (e.g., ventilated enclosure) or personal protective equipment (i.e., N95 respirator). Dispersed tablets are stable in water for up to 4 hours.
Preparation Instructions for Alternative Administration1
_Oral Administration of Dispersed Tablets in Water1_
- Place tablet(s) in container with ~10 mL (5 mL minimum) of room temperature water and disperse by gently swirling tablet(s).
- Take orally immediately.
- Rinse container with additional 10 mL (5 mL minimum) of room temperature water and swallow entire contents.
Administration via G Tube1
- Place tablet(s) in container with ~15 mL (10 mL minimum) of room temperature water and disperse with gentle swirling.
- Ensure tablet(s) are sufficiently dispersed to allow free passage through syringe tip.
- Withdraw entire contents from container into appropriate syringe and immediately administer through gastric feeding tube.
- Rinse container with ~15 mL (10 mL minimum) of room temperature water, withdraw contents into syringe, and administer through tube.
Administration via NG or OG Tube1
- Place tablet(s) in container with ~30 mL of room temperature water and disperse with gentle swirling.
- Ensure tablet(s) are sufficiently dispersed to allow free passage through syringe tip.
- Withdraw entire contents from container into appropriate syringe and immediately administer through enteral feeding tube.
- To avoid clogging of small diameter tubes (smaller than 12 Fr), syringe can be held horizontally and shaken during administration.
- Rinse container with sufficient amount (15 mL minimum) of room temperature water, withdraw contents into syringe, and administer through tube.
**Table 4: Dispersion and Rinse Volume for Alternative Administration1**
| Administration via | Dispersion Volume | Container Rinse Volume |
| --- | --- | --- |
| Oral dispersion | Dispersion Volume:
10 mL | Container Rinse Volume:
10 mL |
| G tube | Dispersion Volume:
15 mL | Container Rinse Volume:
15 mL |
| NG tube or OG tube | Dispersion Volume:
30 mL | Container Rinse Volume:
15 mL |
**Reference**
1. Olumiant. Prescribing information. Lilly USA, LLC.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
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## Olumiant COVID-19 Efficacy
[Skip to main content](https://olumiant.lilly.com/hcp/covid-19/efficacy#maincontent)
# COVID-19 Clinical Data
The efficacy and safety of Olumiant were assessed in two phase 3, randomized, double-blind, placebo-controlled clinical trials1:
- ACTT-2 (COVID I, NCT04401579), which evaluated the combination of Olumiant 4 mg and remdesivir compared to placebo and remdesivir.
- COV-BARRIER (COVID II, NCT04421027), which evaluated Olumiant 4 mg compared to placebo. Patients could remain on background therapy, as defined per local guidelines. An additional exploratory sub-study in patients requiring invasive mechanical ventilation or ECMO at baseline was also conducted under this protocol and analyzed separately.
ACTT-2=Adaptive COVID-19 Treatment Trial 2.
## NIAID Ordinal Scale used in ACTT-2 and COV-BARRIER1
| | |
| --- | --- |
| 1 | Not hospitalized; no limitations on activities |
| 2 | Not hospitalized; limitation on activities and/or requiring home oxygen |
| 3 | Hospitalized; no longer requires ongoing medical care; not requiring supplemental oxygen |
| 4 | Hospitalized; requiring ongoing medical care; not requiring supplemental oxygen |
| 5 | Hospitalized; requiring supplemental oxygen |
| 6 | Hospitalized; on non-invasive ventilation or high-flow oxygen devices |
| 7 | Hospitalized; on invasive mechanical ventilation or ECMO |
| 8 | Death |
ACTT-2=Adaptive COVID-19 Treatment Trial 2.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO SERIOUS INFECTIONS**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant. Closely monitor patients for development of infections during and after Olumiant treatment. In COVID-19 patients, consider the risks and benefits of treatment with OLUMIANT with other concurrent infections.
## ACTT-2 Data Overview
### ACTT-2 (COVID I) Study Design
The Adaptive COVID-19 Treatment Trial 2 (ACTT-2) study was a randomized, double-blind, placebo-controlled clinical trial of hospitalized adults with confirmed SARS-CoV-2 infection that compared treatment with Olumiant and remdesivir (combination group; n=515) to treatment with placebo and remdesivir (placebo group; n=518). Patients had to have laboratory-confirmed SARS-CoV-2 infection\*, as well as at least one of the following to be enrolled in the trial: radiographic infiltrates by imaging, SpO2 ≤94% on room air, a requirement for supplemental oxygen, or a requirement for mechanical ventilation or ECMO.1-3
There was no limit to the duration of symptoms prior to enrollment.3
Patients treated with the combination received the following regimen1,2:
- Olumiant 4 mg once daily (orally) for 14 days or until hospital discharge, whichever was first
- Remdesivir 200 mg on Day 1 and 100 mg once daily (via intravenous infusion) on subsequent days for a total treatment duration of 10 days or until hospital discharge, whichever was first
In this study prophylaxis for venous thromboembolic event (VTEs) was recommended for all patients unless a major contraindication was noted.1,2
The primary endpoint, for the intent to treat population, was time to recovery within 29 days after randomization.
Recovery was defined as1-3:
- being discharged from the hospital without limitations on activities
- being discharged from the hospital with limitations on activities and/or requiring home oxygen, or
- hospitalized but not requiring supplemental oxygen and no longer requiring medical care
The key secondary endpoint was clinical status on Day 15, as assessed on an 8-point ordinal scale (OS).1-3
\*Laboratory-confirmed SARS-CoV-2 infection was determined by RT-PCR assay.3
ECMO=extracorporeal membrane oxygenation; RT-PCR=reverse transcription, polymerase-chain-reaction; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2; SpO2=peripheral oxygen saturation.
[View the Ordinal Scale used in ACTT-2](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=clinical-data)
## Patient Characteristics for ACTT-2
| | All subjects (N=1033) | Olumiant + RDV (N=515) | Placebo + RDV (N=518) |
| --- | --- | --- | --- |
| **Age1,2** |
| Mean, years (SD) | All subjects (N=1033):
55.4 (15.7) | Olumiant + RDV (N=515):
55.0 (15.4) | Placebo + RDV (N=518):
55.8 (16.0) |
| **Distribution, n (%)** |
| <40 years | All subjects (N=1033):
173 (16.7) | Olumiant + RDV (N=515):
87 (16.9) | Placebo + RDV (N=518):
86 (16.6) |
| 40-64 years | All subjects (N=1033):
555 (53.7) | Olumiant + RDV (N=515):
281 (54.6) | Placebo + RDV (N=518):
274 (52.9) |
| ≥65 years | All subjects (N=1033):
305 (29.5) | Olumiant + RDV (N=515):
147 (28.5) | Placebo + RDV (N=518):
158 (30.5) |
| | All subjects (N=1033) | Olumiant + RDV (N=515) | Placebo + RDV (N=518) |
| --- | --- | --- | --- |
| **Sex, n (%)1,2** |
| Male | All subjects (N=1033):
652 (63.1) | Olumiant + RDV (N=515):
319 (61.9) | Placebo + RDV (N=518):
333 (64.3) |
| Female | All subjects (N=1033):
381 (36.9) | Olumiant + RDV (N=515):
196 (38.1) | Placebo + RDV (N=518):
185 (35.7) |
| | All subjects (N=1033) | Olumiant + RDV (N=515) | Placebo + RDV (N=518) |
| --- | --- | --- | --- |
| **Race, n (%)1,2a** |
| Asian | All subjects (N=1033):
101 (9.8) | Olumiant + RDV (N=515):
49 (9.5) | Placebo + RDV (N=518):
52 (10.0) |
| Black | All subjects (N=1033):
156 (15.1) | Olumiant + RDV (N=515):
77 (15.0) | Placebo + RDV (N=518):
79 (15.3) |
| White | All subjects (N=1033):
496 (48.0) | Olumiant + RDV (N=515):
251 (48.7) | Placebo + RDV (N=518):
245 (47.3) |
| Other or Unknown | All subjects (N=1033):
280 (27.1) | Olumiant + RDV (N=515):
138 (26.8) | Placebo + RDV (N=518):
142 (27.4) |
| **Ethnic group, n (%)1,2a** |
| Hispanic or Latino | All subjects (N=1033):
531 (51.4) | Olumiant + RDV (N=515):
263 (51.1) | Placebo + RDV (N=518):
268 (51.7) |
| Not Hispanic or Latino | All subjects (N=1033):
486 (47.0) | Olumiant + RDV (N=515):
246 (47.8) | Placebo + RDV (N=518):
240 (46.3) |
| Not reported or unknown | All subjects (N=1033):
16 (1.5) | Olumiant + RDV (N=515):
6 (1.2) | Placebo + RDV (N=518):
10 (1.9) |
aRace and ethnic group were reported by the patients. With respect to "other" race, the categories that were used when data on race were reported included American Indian or Alaska Native and Native Hawaiian or other Pacific Islander.
| | All subjects (N=1033) | Olumiant + RDV (N=515) | Placebo + RDV (N=518) |
| --- | --- | --- | --- |
| **Geographic region, n (%)2** |
| Asia | All subjects (N=1033):
67 (6.5) | Olumiant + RDV (N=515):
33 (6.4) | Placebo + RDV (N=518):
34 (6.6) |
| Europe | All subjects (N=1033):
13 (1.3) | Olumiant + RDV (N=515):
6 (1.2) | Placebo + RDV (N=518):
7 (1.4) |
| North America | All subjects (N=1033):
953 (92.3) | Olumiant + RDV (N=515):
476 (92.4) | Placebo + RDV (N=518):
477 (92.1) |
| | All subjects (N=1033) | Olumiant + RDV (N=515) | Placebo + RDV (N=518) |
| --- | --- | --- | --- |
| **Time from symptom onset to randomization2** |
| Median days (IQR) | All subjects (N=1033):
8 (5-10) | Olumiant + RDV (N=515):
8 (5-10) | Placebo + RDV (N=518):
8 (5-11) |
| | All subjects (N=1033) | Olumiant + RDV (N=515) | Placebo + RDV (N=518) |
| --- | --- | --- | --- |
| **Ordinal scale score, n (%)1,2** |
| 4 | All subjects (N=1033):
142 (13.7) | Olumiant + RDV (N=515):
70 (13.6) | Placebo + RDV (N=518):
72 (13.9) |
| 5 | All subjects (N=1033):
564 (54.6) | Olumiant + RDV (N=515):
288 (55.9) | Placebo + RDV (N=518):
276 (53.3) |
| 6 | All subjects (N=1033):
216 (20.9) | Olumiant + RDV (N=515):
103 (20.0) | Placebo + RDV (N=518):
113 (21.8) |
| 7 | All subjects (N=1033):
111 (10.7) | Olumiant + RDV (N=515):
54 (10.5) | Placebo + RDV (N=518):
57 (11.0) |
| | All subjects (N=1033) | Olumiant + RDV (N=515) | Placebo + RDV (N=518) |
| --- | --- | --- | --- |
| **Comorbidities at baseline, n (%)1,3b** |
| Obesity | All subjects (N=1033):
567 (56) | Olumiant + RDV (N=515):
295 (58) | Placebo + RDV (N=518):
272 (53) |
| Hypertension | All subjects (N=1033):
522 (52) | Olumiant + RDV (N=515):
258 (51) | Placebo + RDV (N=518):
264 (52) |
| Type 2 diabetes | All subjects (N=1033):
370 (37) | Olumiant + RDV (N=515):
195 (39) | Placebo + RDV (N=518):
175 (35) |
| Coronary artery disease | All subjects (N=1033):
101 (10) | Olumiant + RDV (N=515):
50 (10) | Placebo + RDV (N=518):
51 (10) |
| Asthma | All subjects (N=1033):
97 (10) | Olumiant + RDV (N=515):
53 (10) | Placebo + RDV (N=518):
44 (9) |
| Chronic respiratory disease | All subjects (N=1033):
69 (7) | Olumiant + RDV (N=515):
39 (8) | Placebo + RDV (N=518):
30 (6) |
| Chronic kidney disease | All subjects (N=1033):
64 (6) | Olumiant + RDV (N=515):
31 (6) | Placebo + RDV (N=518):
33 (7) |
| Congestive heart failure | All subjects (N=1033):
62 (6) | Olumiant + RDV (N=515):
31 (6) | Placebo + RDV (N=518):
31 (6) |
| Cancer | All subjects (N=1033):
37 (4) | Olumiant + RDV (N=515):
20 (4) | Placebo + RDV (N=518):
17 (3) |
| Immune deficiency | All subjects (N=1033):
30 (3) | Olumiant + RDV (N=515):
17 (3) | Placebo + RDV (N=518):
13 (3) |
| Chronic liver disease | All subjects (N=1033):
28 (3) | Olumiant + RDV (N=515):
13 (3) | Placebo + RDV (N=518):
15 (3) |
| Any history of DVT or PE | All subjects (N=1033):
22 (2) | Olumiant + RDV (N=515):
11 (2) | Placebo + RDV (N=518):
11 (2) |
| Cardiac valvular disease | All subjects (N=1033):
22 (2) | Olumiant + RDV (N=515):
10 (2) | Placebo + RDV (N=518):
12 (2) |
| Chronic oxygen requirement | All subjects (N=1033):
17 (2) | Olumiant + RDV (N=515):
8 (2) | Placebo + RDV (N=518):
9 (2) |
| Type 1 diabetes | All subjects (N=1033):
10 (1) | Olumiant + RDV (N=515):
5 (1) | Placebo + RDV (N=518):
5 (1) |
| Coagulopathy | All subjects (N=1033):
7 (1) | Olumiant + RDV (N=515):
3 (1) | Placebo + RDV (N=518):
4 (1) |
| **Summary of coexisting conditions, n/total n (%)2** |
| None | All subjects (N=1033):
155/994 (15.6) | Olumiant + RDV (N=515):
64/496 (12.9) | Placebo + RDV (N=518):
91/498 (18.3) |
| One | All subjects (N=1033):
270/994 (27.2) | Olumiant + RDV (N=515):
148/496 (29.8) | Placebo + RDV (N=518):
122/498 (24.5) |
| Two or more | All subjects (N=1033):
569/994 (57.2) | Olumiant + RDV (N=515):
284/496 (57.3) | Placebo + RDV (N=518):
285/498 (57.2) |
bPercentages are based on the number of subjects with data available for the individual comorbidity.
ACTT-2=Adaptive COVID-19 Treatment Trial 2; DVT=deep vein thrombosis; IQR=interquartile range; PE=pulmonary embolism; RDV=remdesivir.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO TUBERCULOSIS**
Evaluate patients for active infection prior to initiating Olumiant. Olumiant should not be given to patients with active TB. Monitor patients for development of signs and symptoms of TB, including patients who tested negative for latent TB prior to initiating therapy.
ACTT-2 Primary Endpoint and Subgroup Analyses - Recovery Outcomes
Down
ACTT-2 Primary Endpoint and Subgroup Analyses - Recovery Outcomes
ACTT-2 Secondary Endpoint and Subgroup Analyses - OS Score at Day 15
ACTT-2 Secondary Endpoint - Progression by Day 29
ACTT-2 Secondary Endpoint & Subgroup Analyses - Mortality
### ACTT-2 Primary Endpoint and Subgroup Analyses - Recovery Outcomes
For the overall population, the median time to recovery (defined as discharged from hospital or hospitalized but not requiring supplemental oxygen or ongoing medical care) was 7 days for Olumiant and remdesivir compared to 8 days for placebo and remdesivir \[hazard ratio: 1.16 (95% CI 1.01, 1.33); p=0.035\].1
#### ACTT-2: Recovery Outcomes in the ITT Population According to Baseline Ordinal Scale Score2
### 4a Not requiring supplemental oxygen
**Recoveries, n**
Olumiant + RDV (n=70): 67
Placebo + RDV (n=72): 69
**Median time to recovery, days (95% CI)**
Olumiant + RDV (n=70): 5 (4-6)
Placebo + RDV (n=72): 4 (4-6)
**HR (95% CI)**
0.88 (0.63-1.23)
aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1
* * *
### 5 Low-flow oxygen
**Recoveries, n**
Olumiant + RDV (n=288): 262
Placebo + RDV (n=276): 243
**Median time to recovery, days (95% CI)**
Olumiant + RDV (n=288): 5 (5-6)
Placebo + RDV (n=276): 6 (5-6)
**HR (95% CI)**
1.17 (0.98-1.39)
* * *
### 6 High-flow oxygen/NIMV
**Recoveries, n**
Olumiant + RDV (n=103): 82
Placebo + RDV (n=113): 73
**Median time to recovery, days (95% CI)**
Olumiant + RDV (n=103): 10 (9-13)
Placebo + RDV (n=113): 18 (13-21)
**HR (95% CI)**
1.51 (1.10-2.08)
* * *
### 7 Mechanical ventilation/ECMO
**Recoveries, n**
Olumiant + RDV (n=54): 22
Placebo + RDV (n=57): 21
**Median time to recovery, days (95% CI)**
Olumiant + RDV (n=54): NE (25-NE)
Placebo + RDV (n=57): NE (26-NE)
**HR (95% CI)**
1.08 (0.59-1.97)
| | **4a**
**Not requiring supplemental oxygen** | **5**
**Low-flow oxygen** | **6**
**High-flow oxygen/NIMV** | **7**
**Mechanical ventilation/ECMO** |
| | Olumiant + RDV (n=70) | Placebo + RDV (n=72) | Olumiant + RDV (n=288) | Placebo + RDV (n=276) | Olumiant + RDV (n=103) | Placebo + RDV (n=113) | Olumiant + RDV (n=54) | Placebo + RDV (n=57) |
| Recoveries, n | 67 | 69 | 262 | 243 | 82 | 73 | 22 | 21 |
| Median time to recovery, days (95% CI) | 5 (4-6) | 4 (4-6) | 5 (5-6) | 6 (5-6) | 10 (9-13) | 18 (13-21) | NE (25-NE) | NE (26-NE) |
| HR (95% CI) | 0.88 (0.63-1.23) | 1.17 (0.98-1.39) | 1.51 (1.10-2.08) | 1.08 (0.59-1.97) |
aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1
Analyses by baseline ordinal scale score, while prespecified, were not adjusted for multiplicity and therefore cannot be used to conclude treatment effects within or between subgroups.
[View the ACTT-2 Study Design](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=actt-2)
[View the Ordinal Scale used in ACTT-2](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=clinical-data)
ACTT-2=Adaptive COVID-19 Treatment Trial 2; ECMO=extracorporeal membrane oxygenation; HR=hazard ratio; ITT=intent-to-treat; NE=not possible to estimate; NIMV=non-invasive mechanical ventilation; RDV=remdesivir.
### ACTT-2 Secondary Endpoint and Subgroup Analyses - OS Score at Day 15
In the overall population, patients assigned to Olumiant and remdesivir were more likely to have a better clinical status (according to an 8-point ordinal scale) at Day 15 compared to patients assigned to placebo and remdesivir \[odds ratio: 1.26 (95% CI 1.01, 1.57); p=0.044\].1
**Ordinal Scale Score at Day 15 According to Baseline Score2:**
### 4a Not requiring supplemental oxygen
**Ordinal scale score at Day 15: 1**
Olumiant + RDV (n=70) n (%): 33 (47.1)
Placebo + RDV (n=72) n (%): 44 (61.1)
**Ordinal scale score at Day 15: 2**
Olumiant + RDV (n=70) n (%): 25 (35.7)
Placebo + RDV (n=72) n (%): 20 (27.8)
**Ordinal scale score at Day 15: 3**
Olumiant + RDV (n=70) n (%): 5 (7.1)
Placebo + RDV (n=72) n (%): 2 (2.8)
**Ordinal scale score at Day 15: 4**
Olumiant + RDV (n=70) n (%): 7 (10.0)
Placebo + RDV (n=72) n (%): 6 (8.3)
**Ordinal scale score at Day 15: 5**
Olumiant + RDV (n=70) n (%): 0 (0)
Placebo + RDV (n=72) n (%): 0 (0)
**Ordinal scale score at Day 15: 6**
Olumiant + RDV (n=70) n (%): 0 (0)
Placebo + RDV (n=72) n (%): 0 (0)
**Ordinal scale score at Day 15: 7**
Olumiant + RDV (n=70) n (%): 0 (0)
Placebo + RDV (n=72) n (%): 0 (0)
**Ordinal scale score at Day 15: 8**
Olumiant + RDV (n=70) n (%): 0 (0)
Placebo + RDV (n=72) n (%): 0 (0)
**OR (95% CI)**
0.6 (0.3-1.1)
aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1
* * *
### 5 Low-flow oxygen
**Ordinal scale score at Day 15: 1**
Olumiant + RDV (n=288) n (%): 114 (39.6)
Placebo + RDV (n=276) n (%): 101 (36.6)
**Ordinal scale score at Day 15: 2**
Olumiant + RDV (n=288) n (%): 120 (41.7)
Placebo + RDV (n=276) n (%): 115 (41.7)
**Ordinal scale score at Day 15: 3**
Olumiant + RDV (n=288) n (%): 2 (0.7)
Placebo + RDV (n=276) n (%): 1 (0.4)
**Ordinal scale score at Day 15: 4**
Olumiant + RDV (n=288) n (%): 14 (4.9)
Placebo + RDV (n=276) n (%): 7 (2.5)
**Ordinal scale score at Day 15: 5**
Olumiant + RDV (n=288) n (%): 18 (6.2)
Placebo + RDV (n=276) n (%): 27 (9.8)
**Ordinal scale score at Day 15: 6**
Olumiant + RDV (n=288) n (%): 9 (3.1)
Placebo + RDV (n=276) n (%): 1 (0.4)
**Ordinal scale score at Day 15: 7**
Olumiant + RDV (n=288) n (%): 8 (2.8)
Placebo + RDV (n=276) n (%): 19 (6.9)
**Ordinal scale score at Day 15: 8**
Olumiant + RDV (n=288) n (%): 3 (1.0)
Placebo + RDV (n=276) n (%): 5 (1.8)
**OR (95% CI)**
1.2 (0.9-1.6)
* * *
### 6 High-flow oxygen/NIMV
**Ordinal scale score at Day 15: 1**
Olumiant + RDV (n=103) n (%): 27 (26.2)
Placebo + RDV (n=113) n (%): 17 (15.0)
**Ordinal scale score at Day 15: 2**
Olumiant + RDV (n=103) n (%): 30 (29.1)
Placebo + RDV (n=113) n (%): 24 (21.2)
**Ordinal scale score at Day 15: 3**
Olumiant + RDV (n=103) n (%): 0 (0)
Placebo + RDV (n=113) n (%): 0 (0)
**Ordinal scale score at Day 15: 4**
Olumiant + RDV (n=103) n (%): 7 (6.8)
Placebo + RDV (n=113) n (%): 3 (2.7)
**Ordinal scale score at Day 15: 5**
Olumiant + RDV (n=103) n (%): 15 (14.6)
Placebo + RDV (n=113) n (%): 20 (17.7)
**Ordinal scale score at Day 15: 6**
Olumiant + RDV (n=103) n (%): 7 (6.8)
Placebo + RDV (n=113) n (%): 16 (14.2)
**Ordinal scale score at Day 15: 7**
Olumiant + RDV (n=103) n (%): 15 (14.6)
Placebo + RDV (n=113) n (%): 28 (24.8)
**Ordinal scale score at Day 15: 8**
Olumiant + RDV (n=103) n (%): 2 (1.9)
Placebo + RDV (n=113) n (%): 5 (4.4)
**OR (95% CI)**
2.2 (1.4-3.6)
* * *
### 7 Mechanical ventilation/ECMO
**Ordinal scale score at Day 15: 1**
Olumiant + RDV (n=54) n (%): 3 (5.6)
Placebo + RDV (n=57) n (%): 3 (5.3)
**Ordinal scale score at Day 15: 2**
Olumiant + RDV (n=54) n (%): 2 (3.7)
Placebo + RDV (n=57) n (%): 4 (7.0)
**Ordinal scale score at Day 15: 3**
Olumiant + RDV (n=54) n (%): 1 (1.9)
Placebo + RDV (n=57) n (%): 0 (0)
**Ordinal scale score at Day 15: 4**
Olumiant + RDV (n=54) n (%): 3 (5.6)
Placebo + RDV (n=57) n (%): 2 (3.5)
**Ordinal scale score at Day 15: 5**
Olumiant + RDV (n=54) n (%): 10 (18.5)
Placebo + RDV (n=57) n (%): 3 (5.3)
**Ordinal scale score at Day 15: 6**
Olumiant + RDV (n=54) n (%): 4 (7.4)
Placebo + RDV (n=57) n (%): 2 (3.5)
**Ordinal scale score at Day 15: 7**
Olumiant + RDV (n=54) n (%): 25 (46.3)
Placebo + RDV (n=57) n (%): 36 (63.2)
**Ordinal scale score at Day 15: 8**
Olumiant + RDV (n=54) n (%): 6 (11.1)
Placebo + RDV (n=57) n (%): 7 (12.3)
**OR (95% CI)**
1.7 (0.8-3.4)
| | **4a**
**Not requiring supplemental oxygen** | **5**
**Low-flow oxygen** | **6**
**High-flow oxygen/NIMV** | **7**
**Mechanical ventilation/ECMO** |
| **Ordinal scale score at Day 15** | **Olumiant + RDV (n=70)**
**n (%)** | **Placebo + RDV (n=72)**
**n (%)** | **Olumiant + RDV (n=288)**
**n (%)** | **Placebo + RDV (n=276)**
**n (%)** | **Olumiant + RDV (n=103)**
**n (%)** | **Placebo + RDV (n=113)**
**n (%)** | **Olumiant + RDV (n=54)**
**n (%)** | **Placebo + RDV (n=57)**
**n (%)** |
| 1 | 33 (47.1) | 44 (61.1) | 114 (39.6) | 101 (36.6) | 27 (26.2) | 17 (15.0) | 3 (5.6) | 3 (5.3) |
| 2 | 25 (35.7) | 20 (27.8) | 120 (41.7) | 115 (41.7) | 30 (29.1) | 24 (21.2) | 2 (3.7) | 4 (7.0) |
| 3 | 5 (7.1) | 2 (2.8) | 2 (0.7) | 1 (0.4) | 0 (0) | 0 (0) | 1 (1.9) | 0 (0) |
| 4 | 7 (10.0) | 6 (8.3) | 14 (4.9) | 7 (2.5) | 7 (6.8) | 3 (2.7) | 3 (5.6) | 2 (3.5) |
| 5 | 0 (0) | 0 (0) | 18 (6.2) | 27 (9.8) | 15 (14.6) | 20 (17.7) | 10 (18.5) | 3 (5.3) |
| 6 | 0 (0) | 0 (0) | 9 (3.1) | 1 (0.4) | 7 (6.8) | 16 (14.2) | 4 (7.4) | 2 (3.5) |
| 7 | 0 (0) | 0 (0) | 8 (2.8) | 19 (6.9) | 15 (14.6) | 28 (24.8) | 25 (46.3) | 36 (63.2) |
| 8 | 0 (0) | 0 (0) | 3 (1.0) | 5 (1.8) | 2 (1.9) | 5 (4.4) | 6 (11.1) | 7 (12.3) |
| OR (95% CI) | 0.6 (0.3-1.1) | 1.2 (0.9-1.6) | 2.2 (1.4-3.6) | 1.7 (0.8-3.4) |
aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1
Analyses by baseline ordinal scale score, while prespecified, were not adjusted for multiplicity and therefore cannot be used to conclude treatment effects within or between subgroups.
The ordinal score at Day 15 (±2 days visit window) is the patient's worst score on the ordinal scale during the previous day.2
[View the ACTT-2 Study Design](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=actt-2)
[View the Ordinal Scale used in ACTT-2](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=clinical-data)
ACTT-2=Adaptive COVID-19 Treatment Trial 2; ECMO=extracorporeal membrane oxygenation; NIMV=non-invasive mechanical ventilation; RDV=remdesivir.
### ACTT-2 Secondary Endpoint - Progression by Day 29
The proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 29 was lower in Olumiant and remdesivir (23%) compared to placebo and remdesivir (28%) \[odds ratio: 0.74 (95% CI 0.56, 0.99); p=0.039\]. Patients who required non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation (including ECMO) at baseline needed to worsen by at least 1 point on an 8-point ordinal scale to progress.1
[View the ACTT-2 Study Design](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=actt-2)
[View the Ordinal Scale used in ACTT-2](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=clinical-data)
ACTT-2=Adaptive COVID-19 Treatment Trial 2; ECMO=extracorporeal membrane oxygenation.
### ACTT-2 Secondary Endpoint & Subgroup Analyses - Mortality
In the overall population, the proportion of patients who died by Day 29 was 4.7% (24/515) for Olumiant and remdesivir compared to 7.1% (37/518) for placebo and remdesivir \[Kaplan-Meier estimated difference in Day 29 probability of mortality: -2.6% (95% CI -5.8%, 0.5%); hazard ratio=0.65 (95% CI: 0.39, 1.09)\].1
**Mortality According to Baseline Ordinal Scale Score2:**
### 4a Not requiring supplemental oxygen
#### **Mortality over first 14 daysb**
**HR (95% CI)**
NE
**No. of deaths**
Olumiant + RDV (n=70): 0
Placebo + RDV (n=72): 0
**Kaplan-Meier estimate of mortality, % (95% CI)**
Olumiant + RDV (n=70): 0 (NE-NE)
Placebo + RDV (n=72): 0 (NE-NE)
#### **Mortality over first 28 daysb**
**HR (95% CI)**
NE
**No. of deaths**
Olumiant + RDV (n=70): 0
Placebo + RDV (n=72): 0
**Kaplan-Meier estimate of mortality, % (95% CI)**
Olumiant + RDV (n=70): 0 (NE-NE)
Placebo + RDV (n=72): 0 (NE-NE)
aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1
* * *
### 5 Low-flow oxygen
#### **Mortality over first 14 daysb**
**HR (95% CI)**
0.73 (0.16-3.26)
**No. of deaths**
Olumiant + RDV (n=288): 3
Placebo + RDV (n=276): 4
**Kaplan-Meier estimate of mortality, % (95% CI)**
Olumiant + RDV (n=288): 1.1 (0.4-3.4)
Placebo + RDV (n=276): 1.5 (0.6-3.9)
#### **Mortality over first 28 daysb**
**HR (95% CI)**
0.40 (0.14-1.14)
**No. of deaths**
Olumiant + RDV (n=288): 5
Placebo + RDV (n=276): 12
**Kaplan-Meier estimate of mortality, % (95% CI)**
Olumiant + RDV (n=288): 1.9 (0.8-4.4)
Placebo + RDV (n=276): 4.7 (2.7-8.1)
* * *
### 6 High-flow oxygen/NIMV
#### **Mortality over first 14 daysb**
**HR (95% CI)**
0.21 (0.02-1.80)
**No. of deaths**
Olumiant + RDV (n=103): 1
Placebo + RDV (n=113): 5
**Kaplan-Meier estimate of mortality, % (95% CI)**
Olumiant + RDV (n=103): 1.0 (0.1-6.7)
Placebo + RDV (n=113): 4.6 (2.0-10.8)
#### **Mortality over first 28 daysb**
**HR (95% CI)**
0.55 (0.22-1.38)
**No. of deaths**
Olumiant + RDV (n=103): 7
Placebo + RDV (n=113): 13
**Kaplan-Meier estimate of mortality, % (95% CI)**
Olumiant + RDV (n=103): 7.5 (3.6-15.2)
Placebo + RDV (n=113): 12.9 (7.7-21.3)
* * *
### 7 Mechanical ventilation/ECMO
#### **Mortality over first 14 daysb**
**HR (95% CI)**
0.69 (0.19-2.44)
**No. of deaths**
Olumiant + RDV (n=54): 4
Placebo + RDV (n=57): 6
**Kaplan-Meier estimate of mortality, % (95% CI)**
Olumiant + RDV (n=54): 7.6 (2.9-19.1)
Placebo + RDV (n=57): 11.3 (5.3-23.5)
#### **Mortality over first 28 daysb**
**HR (95% CI)**
1.00 (0.45-2.22)
**No. of deaths**
Olumiant + RDV (n=54): 12
Placebo + RDV (n=57): 12
**Kaplan-Meier estimate of mortality, % (95% CI)**
Olumiant + RDV (n=54): 23.1 (13.8-37.1)
Placebo + RDV (n=57): 22.6 (13.5-36.4)
| | **4a**
**Not requiring supplemental oxygen** | **5**
**Low-flow oxygen** | **6**
**High-flow oxygen/NIMV** | **7**
**Mechanical ventilation/ECMO** |
| **Ordinal scale score at Day 15** | **Olumiant + RDV (n=70)** | **Placebo + RDV (n=72)** | **Olumiant + RDV (n=288)** | **Placebo + RDV (n=276)** | **Olumiant + RDV (n=103)** | **Placebo + RDV (n=113)** | **Olumiant + RDV (n=54)** | **Placebo + RDV (n=57)** |
| **Mortality over first 14 daysb** |
| HR (95% CI) | NE | 0.73 (0.16-3.26) | 0.21 (0.02-1.80) | 0.69 (0.19-2.44) |
| No. of deaths | 0 | 0 | 3 | 4 | 1 | 5 | 4 | 6 |
| Kaplan-Meier estimate of mortality, % (95% CI) | 0 (NE-NE) | 0 (NE-NE) | 1.1 (0.4-3.4) | 1.5 (0.6-3.9) | 1.0 (0.1-6.7) | 4.6 (2.0-10.8) | 7.6 (2.9-19.1) | 11.3 (5.3-23.5) |
| **Mortality over first 28 daysb** |
| HR (95% CI) | NE | 0.40 (0.14-1.14) | 0.55 (0.22-1.38) | 1.00 (0.45-2.22) |
| No. of deaths | 0 | 0 | 5 | 12 | 7 | 13 | 12 | 12 |
| Kaplan-Meier estimate of mortality, % (95% CI) | 0 (NE-NE) | 0 (NE-NE) | 1.9 (0.8-4.4) | 4.7 (2.7-8.1) | 7.5 (3.6-15.2) | 12.9 (7.7-21.3) | 23.1 (13.8-37.1) | 22.6 (13.5-36.4) |
aOlumiant is not indicated for patients who do not require supplemental oxygen and is indicated for use in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.1
bDays post-randomization noted as "over first 14 days/over 28 days" correspond to study Days 15 and 29, respectively.
Analyses by baseline ordinal scale score, while prespecified, were not adjusted for multiplicity and therefore cannot be used to conclude treatment effects within or between subgroups.
[View the ACTT-2 Study Design](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=actt-2)
[View the Ordinal Scale used in ACTT-2](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=clinical-data)
ACTT-2=Adaptive COVID-19 Treatment Trial 2; ECMO=extracorporeal membrane oxygenation; HR=hazard ratio; NE=not possible to estimate; NIMV=non-invasive mechanical ventilation; RDV=remdesivir.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO VIRAL REACTIVATION**
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before starting therapy with Olumiant.
## COV-BARRIER Data Overview
### COV-BARRIER (COVID II) Study Design
COV-BARRIER was a randomized, double-blind, placebo-controlled clinical trial of hospitalized adults with confirmed SARS-CoV-2 infection that compared treatment with Olumiant 4 mg once daily (n=764) with placebo (n=761). Olumiant was administered for 14 days or until hospital discharge, whichever came first. Patients could remain on background standard of care, as defined per local guidelines, including antimalarials, antivirals, corticosteroids, and/or azithromycin. In this study prophylaxis for venous thromboembolic event (VTE) was required for all patients unless contraindicated. The most frequently used therapies at baseline were1:
- corticosteroids (79% of patients, mostly dexamethasone)
- remdesivir (19% of patients)
Patients had to have laboratory-confirmed SARS-CoV-2 infection, at least one instance of elevation in at least one inflammatory marker (CRP, D-dimer, LDH, ferritin), and at least one of the following to be enrolled in the trial: radiographic infiltrates by imaging, SpO2 <94% on room air, evidence of active COVID infection (with clinical symptoms including any of the following: fever, vomiting, diarrhea, dry cough, tachypnea defined as respiratory rate >24 breaths/min) or requirement for supplemental oxygen. Patients requiring invasive mechanical ventilation or ECMO at baseline were enrolled in an exploratory addendum study of COV-BARRIER. These patients were not included in the main COV-BARRIER study population and were analyzed separately.1
The primary endpoint was the proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation within the first 28 days of the study. Patients who required non-invasive ventilation/high-flow oxygen at baseline needed to worsen by at least 1 point on an 8-point ordinal scale to progress.1
A key secondary endpoint was all-cause mortality by Day 28.1
CRP=C-reactive protein; ECMO=extracorporeal membrane oxygenation; LDH=lactate dehydrogenase; SpO2=oxygen saturation as measured by pulse oximetry.
[View the Ordinal Scale used in COV-BARRIER](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=cov-barrier)
### Patient Characteristics for COV-BARRIER
| | All subjects (N=1525) | Olumiant + SOC (N=764) | Placebo + SOC (N=761) |
| --- | --- | --- | --- |
| **Age1,4** |
| Years, mean (SD) | All subjects (N=1525):
57.6 (14.1) | Olumiant + SOC (N=764):
57.8 (14.3) | Placebo + SOC (N=761):
57.5 (13.8) |
| **Distribution, n (%)** |
| <65 years | All subjects (N=1033):
1026 (67.3) | Olumiant + RDV (N=515):
508 (66.5) | Placebo + RDV (N=518):
518 (68.1) |
| ≥65 years | All subjects (N=1033):
499 (32.7) | Olumiant + RDV (N=515):
256 (33.5) | Placebo + RDV (N=518):
243 (31.9) |
| | All subjects (N=1525) | Olumiant + SOC (N=764) | Placebo + SOC (N=761) |
| --- | --- | --- | --- |
| **Sex, n (%)1,4** |
| Male | All subjects (N=1525):
963 (63.1) | Olumiant + SOC (N=764):
490 (64.1) | Placebo + SOC (N=761):
473 (62.2) |
| Female | All subjects (N=1525):
562 (36.9) | Olumiant + SOC (N=764):
274 (35.9) | Placebo + SOC (N=761):
288 (37.8) |
| | All subjects (N=1525) | Olumiant + SOC (N=764) | Placebo + SOC (N=761) |
| --- | --- | --- | --- |
| **Race, n (%)1,4** |
| American Indian or Alaska Nativea | All subjects (N=1525):
316 (20.7) | Olumiant + SOC (N=764):
148 (19.4) | Placebo + SOC (N=761):
168 (22.1) |
| Asian | All subjects (N=1525):
174 (11.4) | Olumiant + SOC (N=764):
80 (10.5) | Placebo + SOC (N=761):
94 (12.4) |
| Black or African American | All subjects (N=1525):
75 (4.9) | Olumiant + SOC (N=764):
39 (5.1) | Placebo + SOC (N=761):
36 (4.7) |
| Native Hawaiian or other Pacific Islander | All subjects (N=1525):
5 (0.3) | Olumiant + SOC (N=764):
3 (0.4) | Placebo + SOC (N=761):
2 (0.3) |
| White | All subjects (N=1525):
920 (60.3) | Olumiant + SOC (N=764):
480 (62.8) | Placebo + SOC (N=761):
440 (57.8) |
| Multiple | All subjects (N=1525):
3 (0.2) | Olumiant + SOC (N=764):
2 (0.3) | Placebo + SOC (N=761):
1 (0.1) |
| Missing | All subjects (N=1525):
32 (2.1) | Olumiant + SOC (N=764):
12 (1.6) | Placebo + SOC (N=761):
20 (2.6) |
aIncludes participants from Mexico and Latin America.
| | All subjects (N=1525) | Olumiant + SOC (N=764) | Placebo + SOC (N=761) |
| --- | --- | --- | --- |
| **Geographic region, n (%)1,4** |
| Europeb | All subjects (N=1525):
143 (9.4) | Olumiant + SOC (N=764):
73 (9.6) | Placebo + SOC (N=761):
70 (9.2) |
| United States including Puerto Rico | All subjects (N=1525):
320 (21.0) | Olumiant + SOC (N=764):
162 (21.2) | Placebo + SOC (N=761):
158 (20.8) |
| Rest of Worldc | All subjects (N=1525):
1062 (69.6) | Olumiant + SOC (N=764):
529 (69.2) | Placebo + SOC (N=761):
533 (70.0) |
bIncludes Germany, Italy, Spain, and the United Kingdom.
cIncludes Argentina, Brazil, India, Japan, Korea (Republic of), Mexico, and Russian Federation.
| | All subjects (N=1525) | Olumiant + SOC (N=764) | Placebo + SOC (N=761) |
| --- | --- | --- | --- |
| **BMI kg/m2, mean (SD)4** | All subjects (N=1525):
30.5 (6.5) | Olumiant + SOC (N=764):
30.4 (6.4) | Placebo + SOC (N=761):
30.6 (6.6) |
| | All subjects (N=1518) | Olumiant + SOC (N=762) | Placebo + SOC (N=756) |
| --- | --- | --- | --- |
| **Disease duration of symptoms prior to enrollment, n (%)4** |
| <7 days | All subjects (N=1518):
253 (16.7) | Olumiant + SOC (N=762):
137 (18.0) | Placebo + SOC (N=756):
116 (15.3) |
| ≥7 days | All subjects (N=1518):
1265 (83.3) | Olumiant + SOC (N=762):
625 (82.0) | Placebo + SOC (N=756):
640 (84.7) |
| | All subjects (N=1518) | Olumiant + SOC (N=762) | Placebo + SOC (N=756) |
| --- | --- | --- | --- |
| **Ordinal Scale Score, n (%)1,4** |
| 4 | All subjects (N=1518):
186 (12.3) | Olumiant + SOC (N=762):
89 (11.7) | Placebo + SOC (N=756):
97 (12.8) |
| 5 | All subjects (N=1518):
962 (63.4) | Olumiant + SOC (N=762):
490 (64.3) | Placebo + SOC (N=756):
472 (62.4) |
| 6 | All subjects (N=1518):
370 (24.4) | Olumiant + SOC (N=762):
183 (24.0) | Placebo + SOC (N=756):
187 (24.7) |
| | All subjects (N=1518) | Olumiant + SOC (N=762) | Placebo + SOC (N=756) |
| --- | --- | --- | --- |
| **Concomitant medications of interest, n (%)1,4** |
| Remdesivir | All subjects (N=1518):
287 (18.9) | Olumiant + SOC (N=762):
140 (18.4) | Placebo + SOC (N=756):
147 (19.4) |
| Systemic corticosteroids | All subjects (N=1518):
1204 (79.3) | Olumiant + SOC (N=762):
612 (80.3) | Placebo + SOC (N=756):
592 (78.3) |
| Dexamethasone | All subjects (N=1518):
1099/1204 (91.3) | Olumiant + SOC (N=762):
566/612 (92.5) | Placebo + SOC (N=756):
533/592 (90.0) |
| | All subjects (N=1525) | Olumiant + SOC (N=764) | Placebo + SOC (N=761) |
| --- | --- | --- | --- |
| **Comorbidities at baseline, n (%)1,4** |
| Obesity | All subjects (N=1525):
503 (33.0) | Olumiant + SOC (N=764):
250 (32.7) | Placebo + SOC (N=761):
253 (33.2) |
| Diabetes (Type I & Type II) | All subjects (N=1525):
457 (30.0) | Olumiant + SOC (N=764):
224 (29.3) | Placebo + SOC (N=761):
233 (30.6) |
| Hypertension | All subjects (N=1525):
731 (47.9) | Olumiant + SOC (N=764):
365 (47.8) | Placebo + SOC (N=761):
366 (48.1) |
BMI=body mass index; OS=ordinal scale; SD=standard deviation; SOC=standard of care.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO MORTALITY**
In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor compared with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
COV-BARRIER Primary Endpoint
Down
COV-BARRIER Primary Endpoint
COV-BARRIER All-Cause Mortality
COV-BARRIER Mortality by Baseline OS Score
### COV-BARRIER Primary Endpoint
The primary endpoint was the proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation within the first 28 days of the study. Patients who required non-invasive ventilation/high-flow oxygen at baseline needed to worsen by at least 1 point on an 8-point ordinal scale to progress.1
| | Olumiant + SOC (n=764) | Placebo + SOC (n=761) |
| --- | --- | --- |
| Estimated proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 28 | Olumiant + SOC (n=764):
27.8% | Placebo + SOC (n=761):
30.5% |
| Comparison with placebo
OR (95% CI) | 0.85 (0.67, 1.08) |
| p-value | 0.180 |
The difference between the treatment groups was not statistically significant.
[View the COV-BARRIER Study Design](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=cov-barrier)
OR=odds ratio; SOC=standard of care.
### COV-BARRIER All-Cause Mortality
#### **Mortality by Day 28**
In the overall population, the proportion of patients who died by Day 28 was 8.1% (62/764) for Olumiant plus standard of care vs 13.3% (101/761) for placebo plus standard of care (estimated difference in Day 28 probability of mortality = -4.9% \[95% CI: -8.0%, -1.9%\]; HR = 0.56 \[95% CI: 0.41, 0.77\]). This corresponds to a 39.1% relative reduction in mortality and a number needed to treat of 20. This data includes one death in the placebo arm that is not reflected in the figure shown below.1
This was a prespecified analysis that was not type-I error controlled. Therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.
**Kaplan-Meier Estimates of 28-Day All-Cause Mortality in the Overall Population5**
Up
Image Description
A Kaplan-Meier graph of 28-day all-cause mortality for patients in the overall population of the COV-BARRIER study is shown.
In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 764. At Day 7, the number at risk was 725. At Day 14, the number at risk was 684. At Day 21, the number at risk was 664. At Day 27, the number at risk was 648.
In the placebo plus SOC arm, the number at risk at Day 0 was 761. At Day 7, the number at risk was 717. At Day 14, the number at risk was 679. At Day 21, the number at risk was 639. At Day 27, the number at risk was 617.
The hazard ratio was 0.57 with a 95% confidence interval of 0.41 to 0.78.
The number at risk at Day 27 represents the number of participants with available data at Day 28.
HR=hazard ratio; SOC=standard of care.
#### **All-Cause Mortality by Day 60**
**Kaplan-Meier Estimates of 60-Day All-Cause Mortality in the Overall Population5**
Up
Image Description
A Kaplan-Meier graph of 60-day all-cause mortality for patients in the overall population of the COV-BARRIER study is shown.
In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 764. At Day 7, the number at risk was 728. At Day 14, the number at risk was 687. At Day 21, the number at risk was 668. At Day 28, the number at risk was 647. At Day 59, the number at risk was 241.
In the placebo plus SOC arm, the number at risk at Day 0 was 761. At Day 7, the number at risk was 718. At Day 14, the number at risk was 681. At Day 21, the number at risk was 642. At Day 28, the number at risk was 613. At Day 59, the number at risk was 234.
The hazard ratio was 0.62 with a 95% confidence interval of 0.47 to 0.83.
This was a prespecified analysis that was not type-I error controlled. Therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.
The visit at Day 60 was added as a protocol amendment. Results should be interpreted with caution due to the limited patient information available for this analysis.
The number at risk at Day 59 represents the number of participants with available data at Day 60.
[View the COV-BARRIER Study Design](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=cov-barrier)
HR=hazard ratio; SOC=standard of care.
### 28-day all-cause mortality by baseline OS score
In COV-BARRIER, 63% of the overall population required supplemental oxygen (OS 5) at randomization.
**Kaplan-Meier Estimates of 28-Day All-Cause Mortality for Baseline Severity OS 55**
Up
Image Description
A Kaplan-Meier graph of 28-day all-cause mortality for patients with a baseline ordinal scale score of 5 in the COV-BARRIER study is shown.
In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 490. At Day 7, the number at risk was 468. At Day 14, the number at risk was 448. At Day 21, the number at risk was 439. At Day 27, the number at risk was 429.
In the placebo plus SOC arm, the number at risk at Day 0 was 472. At Day 7, the number at risk was 452. At Day 14, the number at risk was 435. At Day 21, the number at risk was 418. At Day 27, the number at risk was 411.
The hazard ratio was 0.72 with a 95% confidence interval of 0.45 to 1.16.
HR=hazard ratio; OS=ordinal scale; SOC=standard of care
In COV-BARRIER, 24% of the overall population required non-invasive ventilation or high-flow oxygen (OS 6) at randomization.1
**Kaplan-Meier Estimates of 28-Day All-Cause Mortality for Baseline Severity OS 65**
Up
Image Description
A Kaplan-Meier graph of 28-day all-cause mortality for patients with a baseline OS score of 6 in the COV-BARRIER study is shown. The figure shows a hazard ratio of 0.52 with a 95% CI of 0.33 to 0.80.
These were prespecified subgroup analyses that were not type-I error-controlled; therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.
The number at risk at Day 27 represents the number of participants with available data at Day 28.
[View the COV-BARRIER All-Cause Mortality Data](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=cov-barrier-cont&tab=cov-barrier-all-cause-mortality)
[View the COV-BARRIER Study Design](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=cov-barrier)
HR=hazard ratio; OS=ordinal scale; SOC=standard of care.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS**
Malignancies were observed in clinical studies with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) and a higher rate of lymphomas were observed in patients treated with the JAK inhibitor compared with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy in patients with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
## COV-BARRIER OS 7 Addendum Data Overview
### COV-BARRIER OS 7 Addendum Study Design
The COV-BARRIER OS 7 addendum study was an exploratory, randomized, double-blind, placebo-controlled substudy of COV-BARRIER of hospitalized adults with confirmed SARS-CoV-2 infection requiring invasive mechanical ventilation or ECMO at baseline. All eligibility criteria were the same as the main COV-BARRIER study, with the exception that patients required invasive mechanical ventilation or ECMO to be enrolled. This substudy compared treatment with Olumiant 4 mg once daily plus standard of care (n=51) with placebo plus standard of care (n=50). All patients received standard of care in keeping with local clinical practice for COVID-19 management, which could include concomitant medications such as corticosteroids, antivirals, and other treatments. In this study prophylaxis for venous thromboembolic event (VTE) was required for all patients unless contraindicated. Olumiant was administered for 14 days or until hospital discharge, whichever occurred first.6
All endpoints in this substudy are considered exploratory. Select prespecified endpoints included all-cause mortality by Day 28 and Day 60.6
COVID-19=coronavirus disease 2019; ECMO=extracorporeal membrane oxygenation; OS=ordinal scale; SARS-CoV-2=severe acute respiratory syndrome coronavirus 2.
### Patient Characteristics for COV-BARRIER OS 7 Addendum Study
| | All subjects (N=101) | Olumiant + SOC (N=51) | Placebo + SOC (N=50) |
| --- | --- | --- | --- |
| **Age, mean (SD)7** |
| Years | All subjects (N=101):
58.6 (13.8) | Olumiant + SOC (N=51):
58.4 (12.4) | Placebo + SOC (N=50):
58.8 (15.2) |
| | All subjects (N=101) | Olumiant + SOC (N=51) | Placebo + SOC (N=50) |
| --- | --- | --- | --- |
| **Sex, n (%)7** |
| Male | All subjects (N=101):
55 (54.5) | Olumiant + SOC (N=51):
25 (49.0) | Placebo + SOC (N=50):
30 (60.0) |
| Female | All subjects (N=101):
46 (45.5) | Olumiant + SOC (N=51):
26 (51.0) | Placebo + SOC (N=50):
20 (40.0) |
aIncludes participants from Mexico and Latin America.
| | All subjects (N=101) | Olumiant + SOC (N=51) | Placebo + SOC (N=50) |
| --- | --- | --- | --- |
| **Race, n (%)7** |
| American Indian or Alaska Nativea | All subjects (N=101):
32 (31.7) | Olumiant + SOC (N=51):
15 (29.4) | Placebo + SOC (N=50):
17 (34.0) |
| Asian | All subjects (N=101):
1 (1.0) | Olumiant + SOC (N=51):
0 (0.0) | Placebo + SOC (N=50):
1 (2.0) |
| Black or African American | All subjects (N=101):
2 (2.0) | Olumiant + SOC (N=51):
1 (2.0) | Placebo + SOC (N=50):
1 (2.0) |
| Multiple | All subjects (N=101):
2 (2.0) | Olumiant + SOC (N=51):
2 (3.9) | Placebo + SOC (N=50):
0 (0.0) |
| White | All subjects (N=101):
62 (61.4) | Olumiant + SOC (N=51):
32 (62.7) | Placebo + SOC (N=50):
30 (60.0) |
| Missing | All subjects (N=101):
2 (2.0) | Olumiant + SOC (N=51):
1 (2.0) | Placebo + SOC (N=50):
1 (2.0) |
| | All subjects (N=101) | Olumiant + SOC (N=51) | Placebo + SOC (N=50) |
| --- | --- | --- | --- |
| **Country, n (%)7** |
| Argentina | All subjects (N=101):
21 (20.8) | Olumiant + SOC (N=51):
12 (23.5) | Placebo + SOC (N=50):
9 (18.0) |
| Brazil | All subjects (N=101):
29 (28.7) | Olumiant + SOC (N=51):
15 (29.4) | Placebo + SOC (N=50):
14 (28.0) |
| Mexico | All subjects (N=101):
31 (30.7) | Olumiant + SOC (N=51):
14 (27.5) | Placebo + SOC (N=50):
17 (34.0) |
| United States | All subjects (N=101):
20 (19.8) | Olumiant + SOC (N=51):
10 (19.6) | Placebo + SOC (N=50):
10 (20.0) |
| | All subjects (N=101) | Olumiant + SOC (N=51) | Placebo + SOC (N=50) |
| --- | --- | --- | --- |
| **BMI kg/m2, mean (SD)7** | All subjects (N=101):
33.2 (7.1) | Olumiant + SOC (N=51):
34.3 (7.8) | Placebo + SOC (N=50):
32.1 (6.3) |
| | All subjects (N=99) | Olumiant + SOC (N=51) | Placebo + SOC (N=48) |
| --- | --- | --- | --- |
| **Disease duration of symptoms prior to enrollment, n (%)7** |
| <7 days | All subjects (N=99):
6 (6.1) | Olumiant + SOC (N=51):
2 (3.9) | Placebo + SOC (N=48):
4 (8.3) |
| ≥7 days | All subjects (N=99):
93 (93.9) | Olumiant + SOC (N=51):
49 (96.1) | Placebo + SOC (N=48):
44 (91.7) |
| | All subjects (N=101) | Olumiant + SOC (N=51) | Placebo + SOC (N=50) |
| --- | --- | --- | --- |
| **Concomitant medications of interest, n (%)7** |
| Remdesivir use | All subjects (N=101):
2 (2.0) | Olumiant + SOC (N=51):
0 (0.0) | Placebo + SOC (N=50):
2 (4.0) |
| Corticosteroid use | All subjects (N=101):
87 (86.1) | Olumiant + SOC (N=51):
43 (84.3) | Placebo + SOC (N=50):
44 (88.0) |
| | All subjects (N=101) | Olumiant + SOC (N=51) | Placebo + SOC (N=50) |
| --- | --- | --- | --- |
| **Comorbidities at baseline, n (%)7** |
| Obesity | All subjects (N=101):
57 (56.4) | Olumiant + SOC (N=51):
28 (54.9) | Placebo + SOC (N=50):
29 (58.0) |
| Diabetes (Type I & Type II) | All subjects (N=101):
36 (35.6) | Olumiant + SOC (N=51):
20 (39.2) | Placebo + SOC (N=50):
16 (32.0) |
| Hypertension | All subjects (N=101):
55 (54.5) | Olumiant + SOC (N=51):
31 (60.8) | Placebo + SOC (N=50):
24 (48.0) |
BMI=body mass index; OS=ordinal scale; SD=standard deviation; SOC=standard of care.
**SELECT IMPORTANT SAFETY INFORMATION RELATED TO MAJOR ADVERSE CARDIOVASCULAR EVENTS**
In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of MACE (defined as cardiovascular death, non-fatal MI, and non-fatal stroke) was observed with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.
### COV-BARRIER OS 7 Addendum Study All-Cause Mortality
#### **COV-BARRIER OS 7 Addendum Study Mortality by Day 28**
The proportion of patients who died by Day 28 was 39.2% (20/51) for Olumiant compared to 58.0% (29/50) for placebo \[estimated difference in Day 28 risk of mortality = -18.8% (95% CI: -36.3%, 0.6%); hazard ratio = 0.54 (95% CI: 0.31, 0.96)\].1
This corresponds to a 32.4% relative reduction in mortality and a number needed to treat of 6.
This was a prespecified exploratory analysis that was not type-I error controlled; therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.
Kaplan-Meier Estimates of 28-Day All-Cause Mortality for Patients in OS 7 at Baseline6
Up
Image Description
A Kaplan-Meier graph of 28-day all-cause mortality for patients in ordinal scale 7 at baseline for the COV-BARRIER OS 7 addendum study is shown.
In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 51. At Day 7, the number at risk was 47. At Day 14, the number at risk was 38. At Day 21, the number at risk was 32. At Day 27, the number at risk was 29.
In the placebo plus SOC arm, the number at risk at Day 0 was 50. At Day 7, the number at risk was 39. At Day 14, the number at risk was 28. At Day 21, the number at risk was 20. At Day 27, the number at risk was 19.
The hazard ratio was 0.54 with a 95% confidence interval of 0.31 to 0.96.
The number at risk at Day 27 represents the number of participants with available data at Day 28.
HR=hazard ratio; OS=ordinal scale; SOC=standard of care.
#### **COV-BARRIER OS 7 Addendum Study Mortality by Day 60**
Kaplan-Meier Estimates of 60-Day All-Cause Mortality for Patients in OS 7 at Baseline1
Up
Image Description
A Kaplan-Meier graph of 60-day all-cause mortality for patients in ordinal scale 7 at baseline for the COV-BARRIER OS 7 addendum study is shown.
In the Olumiant plus standard of care (SOC) arm, the number at risk at Day 0 was 51. At Day 7, the number at risk was 48. At Day 14, the number at risk was 40. At Day 21, the number at risk was 34. At Day 27, the number at risk was 31. At Day 59, the number at risk was 25.
In the placebo plus SOC arm, the number at risk at Day 0 was 50. At Day 7, the number at risk was 39. At Day 14, the number at risk was 28. At Day 21, the number at risk was 20. At Day 27, the number at risk was 19. At Day 59, the number at risk was 16.
The hazard ratio was 0.56 with a 95% confidence interval of 0.33 to 0.97.
This was a prespecified exploratory analysis that was not type-I error controlled; therefore, treatment differences between Olumiant and placebo cannot be regarded as statistically significant.
The numbers at risk at Days 27 and 59 represent the numbers of participants with available data at Days 28 and 60, respectively.
[View the COV-BARRIER OS 7 Addendum Study Design](https://olumiant.lilly.com/hcp/covid-19/efficacy?section=os7-addendum)
HR=hazard ratio; OS=ordinal scale; SOC=standard of care.
**References**
1. Olumiant. Prescribing information. Lilly USA, LLC.
2. Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus remdesivir for hospitalized adults with Covid-19. _N Engl J Med._ 2021;384(9):795-807. doi: 10.1056/NEJMoa2031994
3. Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus remdesivir for hospitalized adults with Covid-19. _N Engl J Med._ 2021;384(suppl):1-55. doi:10.1056/NEJMoa2031994
4. Data on File. Lilly USA, LLC. DOF-BA-US-0081.
5. Marconi VC, Ramanan AV, de Bono S, et al. Efficacy and safety of baricitinib for the treatment of hospitalised adults with COVID-19 (COV-BARRIER): a randomised, double-blind, parallel-group, placebo-controlled phase 3 trial. _Lancet Respir Med._ 2021;9(12):1407-1418. doi: 10.1016/S2213-2600(21)00331-3
6. Ely EW, Ramanan AV, Kartman CE, et al. Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial. _Lancet Respir Med._ Published online February 3, 2022. doi:10.1016/S2213-2600(22)00006-6
7. Data on file. Lilly USA, LLC. DOF-BA-US-0082.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant COVID-19 Safety
[Skip to main content](https://olumiant.lilly.com/hcp/covid-19/safety#maincontent)
# COVID-19 Safety
**SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**_SERIOUS INFECTIONS:_ Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.**
**_MORTALITY:_ Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.**
**_MALIGNANCIES:_ Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE):_ Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_THROMBOSIS:_ Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.**
Adverse Reactions in Patients with COVID-19
The safety of Olumiant was evaluated in two randomized, double-blind, placebo-controlled clinical trials of hospitalized adults with COVID-19 for up to 29 days, in which 1307 patients received at least one dose of Olumiant 4 mg once daily, and 1310 patients received placebo, for up to 14 days or until hospital discharge, whichever occurred first. In these studies, prophylaxis for venous thromboembolic event (VTEs) was recommended or required for all patients unless a major contraindication was noted.1
Overall, the safety profile observed in patients with COVID-19 treated with Olumiant was consistent with the safety profile in patients with rheumatoid arthritis.
Overall Infections \- During the first 29 days of the randomized clinical trials, infections were reported in 194 patients (14.8%) treated with Olumiant 4 mg and by 219 patients (16.7%) treated with placebo. The most commonly reported infection with Olumiant was pneumonia (3.1%).
Serious Infections \- During the first 29 days of the randomized clinical trials, serious infections were reported in 98 patients (7.5%) treated with Olumiant 4 mg and 120 patients (9.2%) treated with placebo. The most commonly reported serious infections with Olumiant were COVID-19 pneumonia (2.1%) and septic shock (2.1%).
Opportunistic Infections \- During the first 29 days of the randomized clinical trials, opportunistic infections were reported in 12 patients (0.9%) treated with Olumiant 4 mg and 14 patients (1.1%) treated with placebo. Tuberculosis was reported in 1 patient (0.1%) treated with Olumiant 4 mg and 0 patients treated with placebo.
Venous Thrombosis Events \- During the first 29 days of the randomized clinical trials, pulmonary embolism was reported in 20 patients (1.5%) treated with Olumiant 4 mg and 11 patients (0.8%) treated with placebo. Deep vein thrombosis was reported in 20 patients (1.5%) treated with Olumiant 4 mg and 18 patients (1.4%) treated with placebo.
**Adverse Reactions That Occurred in ≥1% of Patients Treated with Olumiant 4 mg During the First 29 Days in Placebo-Controlled Trials for COVID-191**
| | **Olumiant 4 mg**
**(N=1307)**
**n (%)** | **Placebo**
**(N=1310)**
**n (%)** |
| --- | --- | --- |
| ALT ≥3 x ULNa | Olumiant 4 mg (N=1307) n (%):
230 (18.1) | Placebo (N=1310) n (%):
201 (16.0) |
| AST ≥3 x ULNa | Olumiant 4 mg (N=1307) n (%):
149 (11.8) | Placebo (N=1310) n (%):
117 (9.4) |
| Thrombocytosis >600,000 cells/mm3a | Olumiant 4 mg (N=1307) n (%):
59 (7.9) | Placebo (N=1310) n (%):
34 (4.6) |
| Creatine Phosphokinase (CPK) >5 x ULNa,b | Olumiant 4 mg (N=1307) n (%):
36 (4.5) | Placebo (N=1310) n (%):
38 (4.7) |
| Neutropenia <1000 cells/mm3a | Olumiant 4 mg (N=1307) n (%):
26 (2.2) | Placebo (N=1310) n (%):
22 (1.8) |
| Deep Vein Thrombosis | Olumiant 4 mg (N=1307) n (%):
20 (1.5) | Placebo (N=1310) n (%):
18 (1.4) |
| Pulmonary embolism | Olumiant 4 mg (N=1307) n (%):
20 (1.5) | Placebo (N=1310) n (%):
11 (0.8) |
| Urinary tract infection | Olumiant 4 mg (N=1307) n (%):
19 (1.5) | Placebo (N=1310) n (%):
13 (1.0) |
aAs assessed by measured values within the clinical trial database. Frequencies are based on shifts from pre-treatment to post-treatment (with number at risk as the denominator), except for ALT and AST for which frequencies are based on observed elevation during treatment.
bCreatine phosphokinase frequencies presented in the table were available for a single trial (COV-BARRIER) in patients with COVID-19 and do not represent integrated data.
[**See ACTT-2 Study Design Here**](https://olumiant.lilly.com/hcp/covid-19/efficacy#actt-2) [**See COV-BARRIER Study Design Here**](https://olumiant.lilly.com/hcp/covid-19/efficacy#cov-barrier) [**See COV-BARRIER OS 7 Addendum Study Design Here**](https://olumiant.lilly.com/hcp/covid-19/efficacy#os7-addendum)
ALT=alanine transaminase; AST=aspartate transaminase; ULN=upper limit of normal.
**References**
1. Olumiant. Prescribing information. Lilly USA, LLC.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNING:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
#### **MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
#### **MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
#### **MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
#### **THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
#### **HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
#### **GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
#### **LABORATORY ABNORMALITIES**
**_Neutropenia -_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia -_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia -_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations -_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations -_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
#### **VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
#### **ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
#### **PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
#### **HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant Dosing Guidelines
[Skip to main content](https://olumiant.lilly.com/hcp/rheumatoid-arthritis/dosing#maincontent)
# Olumiant Dosing
## Dosage and Administration
Recommended Evaluations and Immunization Prior to Treatment Initiation1
Prior to Olumiant treatment initiation, consider performing the following evaluations:
- Active and latent tuberculosis (TB) infection evaluation – Olumiant should not be given to patients with active tuberculosis (TB). If latent infection is positive in patients with RA, consider treatment for TB prior to Olumiant use.
- Viral hepatitis screening in accordance with clinical guidelines.
- Complete blood count – Assess baseline values and verify whether treatment can be initiated: - In patients with RA, Olumiant initiation is not recommended in patients with an ALC <500 cells/µl, ANC <1000 cells/µl, or hemoglobin level <8 g/dL.
- Monitor complete blood counts during treatment and modify dosage as recommended.
- Baseline hepatic and renal function – Assess baseline values and monitor patients for laboratory changes. Modify dosage based on hepatic and renal impairment, and laboratory abnormalities.
In patients with RA, update immunizations in agreement with current immunization guidelines.
Dosage Recommendations in RA1
The recommended dosage of Olumiant is 2 mg once daily orally, with or without food. An alternative administration for patients unable to swallow tablets may be used. See “Alternative Administration” section. Olumiant may be used as monotherapy or in combination with methotrexate or other non-biologic DMARDs.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
Dosage Modifications Due to Infections, Cytopenias and Anemia1
- Avoid use in patients with active, serious or opportunistic infection, including localized infections. If a patient develops a serious infection hold treatment with Olumiant until the infection is controlled.
- Dosage modifications for patients with RA and cytopenias or anemia are described in Table 1.
**Table 1: Dosage Modifications for Cytopenias and Anemia in Patients with RA1**
| Laboratory Analyte | Laboratory Analyte Value | Recommendation |
| --- | --- | --- |
| Absolute Lymphocyte Count (ALC) | Laboratory Analyte Value:
≥500 cells/µL | Recommendation:
Maintain dosage |
| Laboratory Analyte Value:
<500 cells/µL | Recommendation:
Interrupt Olumiant until ALC ≥500 cells/µL |
| Absolute Neutrophil Count (ANC) | Laboratory Analyte Value:
≥1000 cells/µL | Recommendation:
Maintain dosage |
| Laboratory Analyte Value:
<1000 cells/µL | Recommendation:
Interrupt Olumiant until ANC ≥1000 cells/µL |
| Hemoglobin | Laboratory Analyte Value:
≥8 g/dL | Recommendation:
Maintain dosage |
| Laboratory Analyte Value:
<8 g/dL | Recommendation:
Interrupt Olumiant until hemoglobin ≥8 g/dL |
Dosage Modifications for Patients with Renal Impairment or Hepatic Impairment1
_Renal Impairment_
- Dosage modifications for patients with RA and renal impairment are described in Table 2.
**Table 2: Dosage Modification for Patients with RA and Renal Impairment1**
| Renal Impairment Stage | Estimated Glomerular Filtration Rate (eGFR) | Recommendation |
| --- | --- | --- |
| Renal Impairment Stage:
Mild | Estimated Glomerular Filtration Rate (eGFR):
60 - <90 mL/min/1.73 m2 | Recommendation:
2 mg once daily |
| Renal Impairment Stage:
Moderate | Estimated Glomerular Filtration Rate (eGFR):
30 - <60 mL/min/1.73 m2 | Recommendation:
1 mg once daily |
| Renal Impairment Stage:
Severe | Estimated Glomerular Filtration Rate (eGFR):
<30 mL/min/1.73 m2 | Recommendation:
Not recommended |
_Hepatic Impairment_
- Olumiant is not recommended for use in patients with severe hepatic impairment.
- Interrupt Olumiant, if increases in ALT or AST are observed and DILI is suspected, until the diagnosis of DILI is excluded.
Dosage Modifications Due to Drug Interactions1
The recommended dosages of Olumiant in patients with RA taking strong OAT3 inhibitors, such as probenecid, are shown in Table 3:
**Table 3: Dosage Modifications when Coadministered with Strong OAT3 Inhibitors in Patients With RA1**
| Concomitant Medication | Recommendation |
| --- | --- |
| Concomitant Medication:
Strong OAT3 inhibitors (e.g., probenecid) | Recommendation:
If the recommended dosage is 2 mg once daily, reduce dosage to 1 mg once daily. |
| Recommendation:
If the recommended dosage is 1 mg once daily, consider discontinuing probenecid. |
**Alternative Administration**
**Alternative Administration of Patients Unable to Swallow Tablets1**
For patients who are unable to swallow whole tablets, an alternative mode of administration may be considered:
- Oral dispersion
- Gastrostomy tube (G tube)
- Nasogastric tube (NG tube) or orogastric tube (OG tube)
Intact tablets are not hazardous. Tablets may be crushed to facilitate dispersion. It is not known if powder from the crushed tablets may constitute a reproductive hazard to the preparer. If tablets are crushed, use proper control measures (e.g., ventilated enclosure) or personal protective equipment (i.e., N95 respirator). Dispersed tablets are stable in water for up to 4 hours.
For information related to preparation for alternative administration, including dispersion and container rinsing volume, please see the Olumiant Prescribing Information.
**References**
1. Olumiant. Prescribing Information. Lilly USA, LLC. Eli Lilly and Company; 2022.
2. Data on file. Lilly USA, LLC. DOF-BA-US-0001.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNINGS:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
**MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
**MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
**MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
**THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
**HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
**GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
**LABORATORY ABNORMALITIES**
**_Neutropenia –_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia –_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia –_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations –_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations –_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
**VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
**ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
**PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
**HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant for Rheumatoid Arthritis
[Skip to main content](https://olumiant.lilly.com/hcp/rheumatoid-arthritis/moa#maincontent)
# Patient Profile & Mechanism of Action (MOA)
## Are your patients telling you it's time for something else?1-4
Up to 40% of patients receiving a TNFi + cDMARD therapy do not achieve ACR20 response in clinical trials. After a TNFi option fails, does finding the next step feel like a guessing game?
Consider the story of Anna, an established patient who takes a TNFi + cDMARD therapy for her moderately to severely active RA.
**Anna: In her own words**
**Hypothetical patient**
"I'm so stiff, I can barely get out of bed in the morning. I don't think I can take another week like this."
"I can't even make lunches for my kids before school. It puts a huge strain on my family when they have to pick up the slack for me."
"It's been a while since I've had a good day. What if I have to take too many sick days?"
"I'm still hopeful there's a simple-to-take solution that can work quickly to help me feel better."
Given Anna's experience with her current TNFi + cDMARD therapy, is it time to reach for Olumiant?
RA=rheumatoid arthritis; ACR20=American College of Rheumatology 20% improvement criteria; TNFi=tumor necrosis factor inhibitor.
## Olumiant is a JAK inhibitor for the treatment of moderately to severely active RA1
### How does Olumiant work?
- Within the intracellular signaling pathway, JAKs phosphorylate and activate STATs, which modulate gene expression within the cell
- Olumiant modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs
- Within in vitro assays, Olumiant has greater inhibitory potency at JAK1, JAK2, and TYK2, relative to JAK3
The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.
JAK=Janus kinase; STAT=signal transducer and activator of transcription protein; ATP=adenosine 5’-triphosphate; TYK=tyrosine kinase.
**References**
1. Olumiant \[package insert\]. Indianapolis, IN: Eli Lilly and Company; 2021.
2. Strand V, Wright GC, Bergman MJ, _et al._ Patient expectations and perceptions of goal-setting strategies for disease management in rheumatoid arthritis. _J Rheumatol._ 2015;42:2046-2054.
3. Lipsky PE, Van der Heijde D, St. Clair EW, _et al;_ for the anti-tumor necrosis factor trial in rheumatoid arthritis with concomitant therapy study group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. _N Engl J Med._ 2000;343:1594-1602.
4. Keystone EC, Kavanaugh AF, Sharp JT, _et al._ Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy. _Arthritis Rheum._ 2004;50:1400-1411.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNINGS:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
**MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
**MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
**MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
**THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
**HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
**GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
**LABORATORY ABNORMALITIES**
**_Neutropenia –_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia –_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia –_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations –_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations –_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
**VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
**ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
**PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
**HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
The information contained in this section of
[olumiant.lilly.com](https://olumiant.lilly.com/) is intended for US healthcare providers. Please confirm below.
No
[Yes](https://olumiant.lilly.com/)
## Olumiant Safety Information
[Skip to main content](https://olumiant.lilly.com/hcp/rheumatoid-arthritis/safety#maincontent)
# Rheumatoid Arthritis Safety
**SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**_SERIOUS INFECTIONS:_ Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.**
**_MORTALITY:_ Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.**
**_MALIGNANCIES:_ Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE):_ Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.**
**_THROMBOSIS:_ Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.**
## Olumiant Safety
This Olumiant RA safety data set includes over 2500 patients enrolled in 6 randomized, double-blind, placebo-controlled studies (three phase 2, three phase 3) and a long-term extension study. Patients were randomized to placebo (n=1070), Olumiant 2 mg (n=479), or higher dose which is not approved for RA (n-997).
## Common Adverse Reactions for RA1
Adverse reactions occurring in greater than or equal to 1% of patients with RA in placebo-controlled trials for RA
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Image Description
The following adverse reactions occurred in greater than or equal to 1% of patients with RA in placebo-controlled trials from weeks 0 to 16.
The adverse reactions reported for patients taking Olumiant 2 milligrams/day (n=479) were upper respiratory infections (16.3%), nausea (2.7%), herpes zoster (1.0%), and herpes simplex (0.8%).
The adverse reactions reported for patients taking placebo (n=1070) were upper respiratory infections (11.7%), nausea (1.6%), herpes zoster (0.4%), and herpes simplex (0.7%).
In both treatment groups, upper respiratory infections included acute sinusitis, acute tonsillitis, chronic tonsillitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinobronchitis, sinusitis, tonsillitis, tracheitis, and upper respiratory tract infection.
In both treatment groups, herpes simplex included eczema herpeticum, genital herpes, herpes simplex, ophthalmic herpes simplex, and oral herpes.
\*Includes acute sinusitis, acute tonsillitis, chronic tonsillitis, epiglottitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinobronchitis, sinusitis, tonsillitis, tracheitis, and upper respiratory tract infection.
†Includes eczema herpeticum, genital herpes, herpes simplex, ophthalmic herpes simplex, and oral herpes.
Additional adverse drug reaction occurring in fewer than 1% of patients: acne.
Patients in this data set were receiving background cDMARDs.
## Discontinuation rates1
Overall treatment discontinuations due to adverse events
PY=patient years
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The following safety results are for overall treatment discontinuations due to adverse events (AEs) in patients with moderately to severely active rheumatoid arthritis. Data are presented as the number of patients with an event followed by the rate per 100 patient years in parentheses. Patients in this data set were receiving background conventional disease-modifying antirheumatic drugs.
In weeks 0 to 16, the number of patients discontinuing due to AEs was 17 (12.1 per 100 patient-years) in the Olumiant 2 milligrams (mg)/day arm and 35 patients (11.4 per 100 patient-years) in the placebo arm.
In weeks 0 to 52, the number of patients discontinuing due to AEs in the Olumiant 2 mg/day arm was 31 (9.2 per 100 patient-years).
## Adverse Events of Special Interest1
Infections, malignancy, and thrombosis
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Image Description
The following safety results are adverse events of special interest observed in patients with moderately to severely active rheumatoid arthritis (RA). Data are presented as the number of patients with an event followed by the rate per 100 patient years in parentheses. Patients in this data set were receiving background conventional disease-modifying antirheumatic drugs.
From weeks 0-16, serious infections were reported in 13 patients (4.2 per 100 patient-years) assigned to placebo and 5 patients (3.6 per 100 patient-years) treated with Olumiant 2 milligrams (mg)/day. From weeks 0-52, serious infections were reported in 14 patients (4.2 per 100 patient-years) treated with Olumiant 2 mg/day. In the 0 to 52 week exposure population, the most commonly reported serious infections were pneumonia, herpes zoster, and urinary tract infection. Although there were no tuberculosis (TB) events reported for placebo or Olumiant 2 mg in this time period, TB events were reported in patients receiving a higher dose, which is not approved for RA.
From weeks 0-16, opportunistic infections were reported in 2 patients (0.6 per 100 patient-years) assigned to placebo and 0 patients treated with Olumiant 2 mg/day. From weeks 0-52, opportunistic infections were reported in 1 patient (0.3 per 100 patient-years) treated with Olumiant 2 mg/day. Opportunistic infections excluded TB.
From weeks 0-16, malignancy was reported in 0 patients assigned to placebo and 1 patient (0.7 per 100 patient-years) treated with Olumiant 2 mg/day. From weeks 0-52, malignancy was reported in 2 patients (0.6 per 100 patient-years) treated with Olumiant 2 mg/day. Malignancy excluded non-melanoma skin cancer (NMSC).
From weeks 0-16, arterial thrombosis was reported in 1 patient (0.3 per 100 patient-years) assigned to placebo and 2 patients (1.4 per 100 patient-years) treated with Olumiant 2 mg/day. From weeks 0-52, arterial thrombosis was reported in 3 patients (0.9 per 100 patient-years) treated with Olumiant 2 mg/day.
From weeks 0-16, venous thrombosis was reported in 0 patients assigned to placebo and 0 patients treated with Olumiant 2 mg/day. From weeks 0-52, venous thrombosis was reported in 2 patients (0.6 per 100 patient-years) treated with Olumiant 2 mg/day.
Lilly is conducting long-term safety studies, including post-marketing studies, to continue to evaluate the safety of Olumiant. Certain adverse events, such as malignancy, require longer observation periods and larger patient exposure to ascertain risk.
PY=patient years
## Laboratory abnormalities
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Image Description
The following safety results are for laboratory abnormalities during a 16-week treatment period in patients with moderately to severely active rheumatoid arthritis (RA) in the Olumiant 2 mg/day arm (n=479) and the placebo arm (n=1070). Patients in this data set were receiving background conventional disease-modifying antirheumatic drugs.
Neutropenia, defined as neutrophil counts <1000 cells/mm3, occurred in 0.6% of patients in the Olumiant 2 mg/day arm and in 0.0% of patients in the placebo arm.
Platelet elevations, defined as an increase in platelet counts above 600,000 cells/mm3, occurred in 1.1% of patients in the Olumiant 2 mg/day arm and in 1.1% of patients in the placebo arm.
Liver enzyme elevations were observed in patients treated with Olumiant. Alanine aminotransferase (ALT) elevations ≥3 times the upper limit of normal (ULN) occurred in 1.7% of patients in the Olumiant 2 mg/day arm and in 1.0% of patients in the placebo arm. Aspartate aminotransferase (AST) elevations ≥3 times ULN occurred in 1.3% of patients in the Olumiant 2 mg/day arm and in 0.8% of patients in the placebo arm. In a phase 3 study of disease-modifying antirheumatic drug (DMARD) naive patients, during the 24-week treatment period, ALT and AST elevations ≥3 times ULN occurred in 1.9% and 0% of patients treated with methotrexate (MTX) monotherapy, 1.9% and 1.3% of patients treated with baricitinib higher dose monotherapy, and 4.7% and 1.9% of patients treated with baricitinib higher dose plus MTX. Baricitinib is not approved at higher doses for RA.
Lipid elevations were observed in patients treated with Olumiant at week 12. The mean change from baseline in low-density lipoprotein (LDL) cholesterol increased by 8 mg/dL in the Olumiant 2 mg/day arm and decreased by 1 mg/dL in the placebo arm. The mean change from baseline in high-density lipoprotein (HDL) cholesterol increased by 7 mg/dL in the Olumiant 2 mg/day arm and 0 mg/dL in the placebo arm. The mean change from baseline in triglycerides increased by 7 mg/dL in the Olumiant 2 mg/day arm and decreased by 2 mg/dL in the placebo arm. The mean LDL/HDL ratio remained stable.
Creatine phosphokinase (CPK) elevations were observed within one week of starting Olumiant and plateaued after 8 to 12 weeks. At week 16, the mean change from baseline in CPK was 37 IU/L in the Olumiant 2 mg/day arm and 2 IU/L in the placebo arm.
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal; LDL=low-density lipoprotein; HDL=high-density lipoprotein; MTX=methotrexate; CPK=creatinine phosphokinase.
**References**
1. Olumiant \[package insert\]. Indianapolis, IN: Eli Lilly and Company; 2021.
2. Data on file. Lilly USA, LLC. DOF-BA-US-0004.
Important Safety Information and Indication or Indications. Select to Expand.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Important Safety Information. Select to Expand.
IMPORTANT SAFETY INFORMATION
## IMPORTANT SAFETY INFORMATION
### WARNINGS:
**SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS**
**SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:**
- **Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.**
- **Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.**
- **Bacterial, viral, and other infections due to opportunistic pathogens.**
**Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.**
**Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.**
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
**MORTALITY**
**In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
**MALIGNANCIES**
**Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.** A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
**MAJOR ADVERSE CARDIOVASCULAR EVENTS**
**In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.**
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
**THROMBOSIS**
**Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.**
**HYPERSENSITIVITY**
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
**GASTROINTESTINAL PERFORATIONS**
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
**LABORATORY ABNORMALITIES**
**_Neutropenia –_** Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells/mm3) compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ANC <500 cells/mm3.
**_Lymphopenia –_** Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
**_Anemia –_** Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than 8 g/dL.
**_Liver Enzyme Elevations –_** Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) ≥5x upper limit of normal (ULN) and increases of aspartate transaminase (AST) ≥10x ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
**_Lipid Elevations –_** Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
**VACCINATIONS**
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
**ADVERSE REACTIONS**
In RA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In COVID-19 trials, the most common adverse reactions (≥1%) reported with Olumiant were: ALT ≥3x ULN, AST ≥3x ULN, thrombocytosis (platelets >600,000 cells/mm3), creatine phosphokinase >5x ULN, neutropenia (ANC <1000 cells/mm3), DVT, PE, and urinary tract infection.
In AA trials, the most common adverse reactions (≥1%) reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infections, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
**PREGNANCY AND LACTATION**
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
**HEPATIC AND RENAL IMPAIRMENT**
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
**BA HCP ISI ALL 14SEP2022**
**Please click to access full**
**[Prescribing Information](https://uspl.lilly.com/olumiant/olumiant.html?s=pi), including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and**
**[Medication Guide](https://uspl.lilly.com/olumiant/olumiant.html?s=mg).**
Indication or Indications. Select to Expand.
INDICATIONS
## INDICATIONS
**Alopecia Areata**
Olumiant is indicated for the treatment of adult patients with severe alopecia areata.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
**Rheumatoid Arthritis**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers.
**Limitations of Use:** Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants, such as azathioprine and cyclosporine.
**COVID-19**
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
## Are you a US healthcare provider?
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## Olumiant Enrollment Form
# Olumiant® (baricitinib) Rheumatology ENROLLMENT FORM
PUBLISHED 06/2025
To prevent delays in getting your Patient started, please complete in full. Items with † are required to complete enrollment. Upon completion, submit pages 1-4 via fax at 1-844-658-4268 or upload online at patientsupportnow.org and code 844658426
# THIS PAGE MUST BE SUBMITTED
# SECTION 1: PATIENT INFORMATION
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By checking the box, I agree to be contacted to: provide feedback on my experience with the related products, services, and programs; to share my story; and, to participate in market and medical research studies about products and services.
HIPAA AUTHORIZATION NEEDED: PATIENT SIGNATURE REQUIRED AT BOTTOM OF PAGE 4 FOR ENROLLMENT
# SECTION 2: INSURANCE INFORMATION
# SECTION 3: SERVICE SELECTION
Please select if you would like to enroll by checking the corresponding checkbox below. By enrolling in the service below, you are agreeing to the Terms of Participation and consenting to the collection of your information, inclusive of health information as described under the Privacy Notice on page 6.
1. Savings Card: Provides eligible, commercially-insured Patients with options to save on treatment costs SAVINGS CARD ELIGIBILITY (must confirm the below statements in order to be eligible)
I confirm that I am a resident of the United States or Puerto Rico who is 18 years of age I confirm that I am NOT enrolled in a government-funded healthcare program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state prescription drug assistance program
# TERMS OF PARTICIPATION AND PROGRAM DISCLOSURES:
Your healthcare provider has talked with you about using Olumiant®, an Eli Lilly and Company medicine. Lilly Support Services™ for Olumiant® offers personalized support to Patients at no charg e and was created to hel get started with and use this medicine. By checking the corresponding optional boxes above, you consent t ®, you understand and authorize Lilly USA, nts, representatives, and service (tog d treatment to administe and information and materials direct llments and use of thes other activities related to y ur health, is needed to f information about Lilly's privacy practices, please see our Privacy Statement at [https://privacynotice.l](https://privacynotice.l/) e Con ps://w llyhub.com/legal/ lillyusa/CHPN.html.
# Olumiant® (baricitinib) Rheumatology ENROLLMENT FORM
PUBLISHED 06/2025
# THIS PAGE MUST BE SUBMITTED
# SECTION 4: PRESCRIBER INFORMATION
Prescriber Name (First, Last)† NPI #† Practice Name† Office Phone† (000-000-0000) Office Fax† (000-000-0000) Office Address† Office City† Office State† Office Zip† Group Tax ID Office Contact Name Office Contact Phone (000-000-0000) Office Contact Email Collaborating Physician NPI
# SECTION 5: DIAGNOSIS
Name of Patient† (First, MI, Last) DOB† (MM/DD/YYYY) Patient Address† Patient City† Patient State† Patient Zip† Diagnosis (select one)†: M05.9 Rheumatoid Arthritis with Rheumatoid Factor, unspecified Other ICD-10-CM Code
# SECTION 6: HCP SERVICE SELECTION & PRESCRIPTION
# Benefits Investigation Support (SELECT ONE)†
Lilly Conducted Benefits Investigation–IF CHECKED, MUST FILL OUT PRESCRIPTION SECTION BELOW.
Lilly Support Services™ for Olumiant® will research the Patient’s insurance and in-network Specialty Pharmacy options to help identify the lowest out-of-pocket cost available for Olumiant® and will forward the prescription to the Specialty Pharmacy that the Patient selects. A Lilly Support Services™ for Olumiant® representative will help triage and troubleshoot access issues on the Patient’s behalf.
# OR
Specialty Pharmacy Conducted Benefits Investigation– IF CHECKED, MUST COMPLETE FIELDS BELOW.
Specialty Pharmacy where prescription was sent
Specialty Pharmacy Phone Number (000-000-0000)
# Olumiant® Rheumatology Prescription — Fill out corresponding prescription below and sign at the bottom of the page
# You must select the Inadequate Response and Dosing
By signing below, I certify: 1) The therapy is medically necessary and that this information is accurate to the best of my knowledge; 2) I am disclosing this information to Eli Lilly and Company, Lilly USA, LLC, their affiliates, agents, representatives, business partners, and service providers (together “Lilly”) to help enable treatment for this Patient; 3) The Patient is aware of, has consented to, and has directed my disclosure of their information to Lilly so that Lilly may contact the Patient to further enable services for those purposes and that such consent and direction applies to disclosures made through the duration of the Patient’s therapy; 4) I will not seek reimbursement from any third party for the support Lilly provides; and 5) I am licensed to prescribe the prescription medication identified in this form, the prescription complies with my state specific prescribing requirements and I appoint Lilly as my agent for the limited purposes of conveying this prescription by facsimile only to the dispensing pharmacy. I understand that by signing this form, I am requesting support from Eli Lilly and Company for Patients receiving Olumiant® pursuant to an FDA approved indication. PRESCRIBER SIGNATURE: PRESCRIBER MUST MANUALLY SIGN AND DATE. Rubber stamps, signature by other office personnel for the Prescriber, and computer-generated signatures will not be accepted.
# Olumiant® (baricitinib) Rheumatology ENROLLMENT FORM
PUBLISHED 06/2025
# HIPAA AUTHORIZATION
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You have selected Eli Lilly and Company (“Lilly”) to coordinate certain services related to your health and to provide information related to your health (Lilly’s “Programs and Services”). In order for Lilly to offer the Programs and Services, Lilly may need to obtain or exchange your protected health information (“PHI”) as defined under the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”) from your Health Care Entities (as defined below). PHI can be inclusive of “sensitive data” as defined by applicable U.S. privacy laws. After your PHI has been released to Lilly, it is no longer covered by HIPAA. By signing this form, you understand and authorize your Health Care Entities to share your PHI with Lilly and use as explained below.
# PHI includes the following individually identifiable information:
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# If you agree, your PHI may be collected from and shared by these entities (together “Health Care Entities”):
• Your doctors and other healthcare providers
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• Others who might have your PHI on behalf of your healthcare providers, pharmacies and healthcare plans
# How Your PHI Will Be Used
Your PHI will be used to enroll you in, provide you with, and operate and administer the Programs and Services, consistent with Lilly’s Privacy Statement and Consumer Health Privacy Notice, including to:
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# Olumiant® (baricitinib) Rheumatology ENROLLMENT FORM
PUBLISHED 06/2025
# HIPAA AUTHORIZATION
# THIS PAGE MUST BE SUBMITTED
# Other things you should know about how we may use and share your PHI:
We do not ask for any PHI that we do not need, but we may receive some in the health records sent to us. Your PHI will be released to Lilly and its wholly owned subsidiaries (“Lilly” or “we”) and/or entities or persons that work on behalf of, or in partnership with, Lilly but are not Lilly employees (“Third Parties”).
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AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION: I authorize my Health Care Entities to disclose my PHI and sensitive data for the purposes as described in this HIPAA Authorization. This HIPAA Authorization replaces any prior HIPAA Authorizations that I may have provided at a specific program level.
By signing this form, I attest that I have read and agree to the Patient HIPAA Authorization.
I understand I am entitled to a copy of this signed Authorization.
# SIGN and DATE
Signature of Patient†
Not signing this form will result in an incomplete submission and a delay in requested services
Printed Name of Patient
Signature Date† (MM/DD/YYYY)
Patient Date of Birth (MM/DD/YYYY)
# Olumiant® (baricitinib) Rheumatology ENROLLMENT FORM
# SAVINGS CARD TERMS AND CONDITIONS
By enrolling in the Olumiant Savings Card Program (“Program”) and using the Olumiant Savings Card (“Card”), you attest that you meet the eligibility criteria, agree to, and will comply with the terms and conditions described below:
# Card Eligibility:
(1.) You have been prescribed Olumiant® (baricitinib) for an approved use consistent with FDA-approved product labeling;
(2.) You are enrolled in a commercial drug insurance plan;
(3.) You are not enrolled in any state, federal, or government funded healthcare program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state prescription drug assistance program;
(4.) You are a resident of the United States or Puerto Rico; and
(5.) You are 18 years of age or older.
# Card Terms and Conditions:
For patients with commercial drug insurance coverage for Olumiant: You must have commercial drug insurance that covers Olumiant and a prescription for an approved use consistent with FDA-approved product labeling to pay as little as $$ 5$ for a 1-month prescription fill of Olumiant. Month is defined as 30 days. Card must be first used by no later than 12/31/2025. Card savings are subject to a maximum monthly savings of wholesale acquisition cost plus usual and customary pharmacy charges and a separate maximum annual savings of up to $$ 9,200$ per calendar year. Card may be used for up to a maximum of 13 prescription fills per calendar year and up to a maximum of 24 prescription fills over the lifetime of the Program, subject to the previously stated maximum monthly and annual savings limit. Except where prohibited by applicable state law, Card monthly and annual savings are reduced if Lilly identifies that you are enrolled in a plan or program, sometimes called a maximizer plan, that adjusts your cost sharing amount to be equal to or include some portion of the savings provided by the Card and attempts to prevent the savings from this Card from being applied to your out-of-pocket costs, including but not limited to copayments, coinsurances, and deductibles (“Maximizer”). If the Program identifies you are enrolled in a Maximizer, Card savings are reduced to a maximum annual savings of up to $$ 6000$ per calendar year. If you have reason to believe that the Program erroneously identified enrollment in a Maximizer, please call the Olumiant Savings Card Program at 1-800-LillyRx (1-800-545-5979). Participation in the Program requires a valid patient HIPAA authorization upon enrollment into the Program. Subject to Lilly USA, LLC’s right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions which may occur at Lilly’s sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
For patients with commercial drug insurance who do not have coverage for Olumiant: You must have commercial drug insurance that does not cover Olumiant and a prescription for an approved use consistent wi pproved product labeling to pay as little as $$ 25$ for a nth supply of Olumiant. Month is defined as 30 days. Card must be first used by no later than 31/2025. Card savings are subject to a maximum monthly savin d a separate maximum annual savings. Card may be used for up to a max rescription fills per year and up to a maximum 24 presc iption fills over the lifetime of the Program, subject to the maximum monthly and annual saving limi Car st be first used by no later than 12/31/2025. Participation in the Progr m requires submission of a prior authorization (PA) prior to the first prescri is denied, a peal must be submitted prior to 5th month prescription fill. To remain eligible for the Program, a new PA, appeal, or medical t be submitted prior to the 13th prescription fill and as d by Lilly at its sole discretion. Participation in the Program requires a valid patient in the Program. Subject to Lilly USA, LLC’s right to ter minate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and co ns, which may occur at Lilly’s sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
# Additional Program Terms and Conditions
If you have an insurance plan that is participating in an alternate funding program (“AFP”) that requires you to apply to the Olumiant Savings Card Program or otherwise pursue specialty drug prescription coverage through an alternate funding vendor as a condition of, requirement for, or prerequisite to coverage of Olumiant, you are not eligible for and are prohibited from using the Olumiant Savings Card Program. AFPs include programs where coverage, reimbursement, or patient out of pocket costs for a product in some way vary based on the availability of a manufacturer co-pay program. AFPs may modify, delay, deny, restrict, or withhold insurance benefits or coverage from patients, or exclude Lilly products from coverage contingent upon a member’s use of Olumiant Savings Card Program. You agree to inform Olumiant Savings Card Program if you are or become a member of such an alternative funding program. You are responsible for any applicable taxes, fees, and any amount that exceeds the applicable monthly or annual maximum Card savings. Monthly and annual maximum savings are set at Lilly’s sole and absolute discretion and may be changed with or without notice at any time for any reason. At its sole discretion and with or without notice, Lilly may reduce, eliminate, or otherwise modify the Card savings for any reason, including but not limited to if your commercial drug insurance plan imposes additional requirements which limits or prevents you from receiving coverage for Olumiant, only allows partial coverage for Olumiant, removes coverage for Olumiant and requires you to utilize the Card, does not provide a material level of financial assistance for the cost of Olumiant, or does not apply Card payments to satisfy your co-payment, deductible, or coinsurance for Olumiant. Card savings are not valid for: Massachusetts residents if an AB-rated generic equivalent is available; California residents if an FDA-approved therapeutic equivalent is available. You must meet the Card eligibility criteria, terms and conditions every time you use the Card. If at any time you begin receiving drug coverage under any state, federal, or government funded healthcare program, you understand that you will no longer be eligible for the Olumiant Savings Card and agree to call the Olumiant Savings Card Program at 1-800-LillyRx (1-800-545-5979) to stop participation. Card activation is required. You may not seek reimbursement from your health insurance, any third party, or any health savings, flexible spending, or other healthcare reimbursement accounts, for any amount of the savings received through the Card. By utilizing the Card, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you will notify your Insurance Carrier of your redemption of the Card. Card savings cannot be combined or utilized with any other program, discount, discount card, cash discount card, coupon, incentive, or similar offer involving Olumiant. You agree that this Card savings is intended solely for the benefit of you, the patient, and that the Card benefits are nontransferable. It is prohibited for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade, or to counterfeit the Card. THIS CARD IS NOT INSURANCE. Lilly has the sole right to interpret and apply Card eligibility criteria, and terms and conditions. Card eligibility, and terms and conditions may be terminated, rescinded, revoked, or amended by Lilly at any time without notice and for any reason. Lilly’s sole discretion to terminate, rescind, revoke, or amend Card eligibility and/or Card terms and conditions includes the right to terminate any individual Card if Lilly determines, in its sole discretion, that a patient does not satisfy the Card’s eligibility criteria or is using or has attempted to use the Card inconsistently with these terms and conditions. Eligibility criteria, and terms and conditions for the Olumiant Savings Card Program may change from time to time; the most current version can be found at [https://www.olumiant.lilly.com/savings-support](https://www.olumiant.lilly.com/savings-support). You may be required to obtain a new Card, including if any Card terms and conditions have been terminated, rescinded, revoked, or amended by Lilly. Card void where prohibited by law. Subject to Lilly’s right to terminate, rescind, revoke or amend Card eligibility criteria and/or Card terms and conditions, which may occur at Lilly’s sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
# Olumiant® (baricitinib) Rheumatology ENROLLMENT FORM
PUBLISHED 06/2025
# PRIVACY NOTICE
This Privacy Notice (“Notice”) is intended to supplement the Eli Lilly and Company Privacy Statement ( [https://privacynotice.lilly.com](https://privacynotice.lilly.com/)) and the Consumer Health Privacy Notice ( [https://www.lillyhub.com/legal/lillyusa/CHPN.html](https://www.lillyhub.com/legal/lillyusa/CHPN.html)) that can be accessed in the footers of Lilly’s websites. This Notice is to provide you with information about the personal information, including health information, we may collect, use, disclose or otherwise process, and your rights and choices with respect to your information.
The categories of health information we collect will depend on how you interact with Lilly Services and the information you choose to provide We may collect:
• Health conditions, treatments, diseases, or diagnosis • Social, psychological, behavioral, and medical interventions • Health-related surgeries or procedures • Use or purchase of prescribed medication • Bodily functions, vital signs, symptoms, or measurements of other types of consumer health data • Diagnoses or diagnostic testing, treatment, or medication
• Reproductive or sexual health information
• Biometric data
• Genetic data
• Data that identifies a consumer seeking health care services • Other information that may be used to infer or derive data related to the above or other health information.
With your consent, we may use the health information we collect for the following purposes, as further described in our privacy statements:
• Providing Services and support.
• Analytics and improvement.
• Customization and personalization.
• Marketing and advertising. • Security and protection of rights.
• Legal proceedings and obligations.
• General business and operational support.
illy does not sell or share your health information with third parties without your consent or authorization. We may disclose health information o our processors for our business purposes or at your direction to provide you with products and Services that you request.
We may use and save your personal information to meet legal or regulatory obligations that are in the legitimate interest of Lilly, to fulfill legitimate and lawful business purposes in accordance with Lilly’s record retention policies and applicable laws and regulations, and to respond to lawful requests by public authorities, including to comply with national security or law enforcement requests.
Some of this personal information may be considered sensitive under applicable laws, such as information about your health or medical diagnosis and demographic information collected in some circumstances, such as race, ethnic origin, and sexual orientation. We may process your sensitive PI with you consent, or as otherwise permitted by law.
Upon verification, you have rights with respect to the collection, use and storage of your information. These rights may include access to your information and how it is being used or shared, the right to correct, delete or limit use of your information or to withdraw consent for us to collect and use your information. There may be certain exceptions and limitations that apply to your request including the right to have your information transmitted to another entity or person in a machine-readable format. To exercise your rights, you or your authorized representative may submit a request to [datarights@lilly.com](mailto:datarights@lilly.com) or 1-800-Lilly-Rx (1-800-545-5979). You will not be discriminated against for exercising any of your rights. You may be entitled, in accordance with applicable law, to appeal a refusal to take action on your request. To do so, please contact us by using one of the methods listed here or in How to Contact Us section of the online Privacy Statement.
If you wish to raise a complaint on how we have handled your personal information, you can contact the Global Privacy Office and Data Protection Officer at [privacy@lilly.com](mailto:privacy@lilly.com), who will investigate the matter. If you are not satisfied with our response or have any concerns about how your data is being processed, you can register a complaint with a relevant regulatory authority (e.g., a Data Protection Authority (DPA) or Attorney General).
## Olumiant Appeal Letter Guide
# Letter of Appeal Guide
The following information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. Providers are encouraged to contact the patient’s health plan for specific information on their coverage policies. For more information, please call Lilly Support Services™ for Olumiant® at 1-800-LillyRx (1-800-545-5979).
# Composing a Letter of Appeal Guide
If coverage is denied by the patient’s health plan, the plan may require an Appeal Letter. The sample letter attached to this document features information that many plans require to process a coverage authorization appeal. Many health plans require that a Letter of Medical Necessity (LMN) accompany submissions of Appeal, therefore consider including an LMN upfront with appeal submission. Please see the LMN Guide for more details. Follow the patient’s plan requirements when requesting Olumiant® (baricitinib); otherwise, treatment initiation may be delayed. An Appeal Letter originates from the patient and the prescribing HCP. It should be submitted with the following 2 additional items: the patient’s medical records and a Letter of Medical Necessity (LMN).
# Appeal considerations to support coverage
General Clinical Information
Below are 3 tips that may be helpful when appealing a coverage denial:
Provide a copy of the patient’s record with details on the patient’s condition (diagnosis/diagnoses), International Classification of Diseases, Tenth Revision
(ICD-10) code, and assessment of severity of disease for which Olumiant is being/will be used, including: ‒ Severity of Alopecia Tool (SALT) score ‒ alternative disease severity classification tool(s) ‒ recent history of infection(s), along with any allergies and existing comorbidities
Provide information about the current treatment(s) being used for the patient’s condition and how the patient is presenting clinically while taking the current treatment(s)
Document the previous therapies used, dates used, and reasons for discontinuation (if applicable)
# Appeal-specific rationale
Clinical rationale should focus only on the stated denial reason.
The following tips may help construct an appropriate appeal:
• Provide clinically relevant and patient-specific information that supports overturning denial
• If denial was due to the plan’s preferred formulary agents not being used to treat this patient, provide the clinical rationale for why these agents are not appropriate for the patient
• Provide clinically relevant and patient-specific information that makes Olumiant an appropriate therapy for this patient
Consider including disease severity classification tool in chart notes or attachments to support Appeal Letter (i.e., Alopecia Areata Scale)
# Lilly Support Services™ will work with you to help navigate patient access
For more information, please visit [https://olumiant.lilly.com/hcp/support-resources](https://olumiant.lilly.com/hcp/support-resources) or call Lilly Support Services™ at 1-800-LillyRx (1-800-545-5979).
# INDICATION
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata. Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
# SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS
SERIOUS INFECTIONS: Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
MORTALITY: Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.
MALIGNANCIES: Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.
MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE): Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.
THROMBOSIS: Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial
thrombosis was observed with another JAK inhibitor vs. TNF blockers.
# Letter of Appeal Guide
This template can be used by HCPs when appealing a coverage denial.
# Sample Letter of Appeal for Olumiant with instructions
View an example on page 5 for use on your office letterhead.
# Indication and Important Safety Information
# INDICATION
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or othe potent immunosuppressants.
# IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS
SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:
• Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use. • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. • Bacterial, viral, and other infections due to opportunistic pathogens
Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
# MORTALITY
In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
# MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
# MAJOR ADVERSE CARDIOVASCULAR EVENTS
In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
# IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets (Cont’d)
# A LillyMedicine
# THROMBOSIS
Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.
# HYPERSENSITIVITY
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
# GASTROINTESTINAL PERFORATIONS
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
# LABORATORY ABNORMALITIES
Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells $' \\mathrm { m m } ^ { 3 }$ ) compared to placebo. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3.
Lymphopenia – Absolute lymphocyte count (ALC) $< 5 0 0$ cells $\\mathsf { m m } ^ { 3 }$ were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC $< 5 0 0$ cells/mm3.
Anemia – Decreases in hemoglobin levels to $< 8 \\mathrm { g / d L }$ were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin ${ < } 8 \\mathrm { g } / \\mathrm { d } L$ .
Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) $\\ge 5 \\times$ upper limit of normal (ULN) and increases of aspartate transaminase (AST) ${ \\geq } 1 0 \\times$ ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
# VACCINATIONS
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
# ADVERSE REACTIONS
In RA trials, the most common adverse reactions $( \\ge 1 % )$ reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In AA trials, the most common adverse reactions $( \\geq 1 % )$ reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infection, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
# PREGNANCY AND LACTATION
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
# HEPATIC AND RENAL IMPAIRMENT
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
# BA HCP ISI RA-AA 14SEP2022
Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide.
# Sample Letter of Appeal for Olumiant® (baricitinib)
ATTN:
Re: Appeal of Denial for Olumiant® (baricitinib)
To Whom It May Concern:
I am writing to appeal your denial of coverage for Olumiant, which I have prescribed for . I understand yo are denying coverage for because
However, I believe the treatment with Olumiant is reasonable, appropriate, and medically necessary for my patient based on my clinical experience, the patient’s condition, and their medical history.
# Clinical Information to Support Appeal
has been diagnosed with since .
# Treatment History
# Clinical Rationale
If you have any additional questions, please contact me at or via email at .
Thank you for your time and consideration.
Sincerely,
Enclosed:
## Olumiant COVID-19 Reimbursement
# Reimbursement of Olumiant for treatment of COVID-19 in the inpatient setting
The following information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. Individual coding decisions should be based upon diagnosis and treatment of individual patients. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. Providers are encouraged to contact third-party payers for specific information on their coverage, coding, and payment policies. Please consult with your legal counsel or reimbursement specialist for any reimbursement or billing questions.
# Indication:
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
# SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS
SERIOUS INFECTIONS: Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
MORTALITY: Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.
MALIGNANCIES: Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients.
MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE): Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.
THROMBOSIS: Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.
Please see Important Safety Information, including Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis on page 6-9. Please click to access Prescribing Information and Medication Guide.
Access to coronavirus disease 2019 (COVID-19) therapies administered in the hospital setting will follow existing site-of-care policies for inpatient reimbursement, along with COVID-19–specific enhancements in some cases. For Medicare patients, hospitals will receive an additional payment when treatment includes Olumiant to treat those diagnosed with COVID-19.1
# SELECT IMPORTANT SAFETY INFORMATION RELATED TO SERIOUS INFECTIONS
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant. Closely monitor patients for development of infections during and after Olumiant treatment. In COVID-19 patients, consider the risks and benefits of treatment with OLUMIANT with other concurrent infections.
Please see Important Safety Information, including Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis on page 6-9. Please click to access Prescribing Information and Medication Guide.
# The Centers for Medicare & Medicaid Services (CMS) has enhanced payments for eligible inpatient treatment of COVID-191
olumiant (baricitinib) tablets 4 mg, 2mg,1mg
# New COVID Treatments Add-On Payment (NCTAP) program1
• CMS provides a payment enhancement under the NCTAP program for eligible hospital inpatient cases that involve the use of certain new products or treatments with current FDA approval or an EUA to treat COVID-19
# The NCTAP is equal to the lesser of:
• $6 5 %$ of the operating outlier threshold for the claim, or • $6 5 %$ of the amount by which the costs of the case exceed the standard diagnosis-related group (DRG) payment\*
Click here to learn more about NCTAP.
# Medicare DRG enhancement for COVID-19 cases2
• Section 3710 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act provides for an increase in the weighting factor for an assigned DRG by $20 %$ for an individual diagnosed with COVID-19 and discharged during the public health emergency (PHE) • In addition to the NCTAP, CMS applies this enhancement to COVID-19–eligible DRGs (U07.1 for discharges on or after April 1, 2020, continuing through the remainder of the COVID-19 PHE period)
# Medicaid is required to cover COVID-19 treatment if states accept additional federal funding for COVID-19
• States must cover, under the state plan (or waiver), testing services and treatments for COVID-19, including vaccines, specialized equipment, and therapies, for any quarter in which the temporary $6 . 2 %$ increase in the federal medical assistance percentage is claimed3
\*Including the adjustment to the relative weight under section 3710 of the CARES Act for eligible cases.1
# DID YOU KNOW?
A DRG is a clinically cohesive group of hospital services that require a similar amount of hospital resources and exhibit similar length-of-stay patterns.4
Under DRG payment, there is not typically a specific separate payment for drugs, devices, or supplies.5
# DID YOU KNOW?
Medicaid uses similar payment methods to Medicare to reimburse hospitals for inpatient care.6
Base payment: The base payment rates are reimbursed
through fee-for-service (FFS) or managed care
arrangements for services provided to Medicaid
beneficiaries. States have wide discretion in setting
these rates
• Supplemental payments: Supplemental payments are payments beyond the base rate that may or may not be tied to specific services
# ICD-10 codes and NCTAP coding information
# The ICD-10-CM diagnostic code set has a new code to distinguish COVID-19 patient discharges.2
U07.1 For discharges on or after April 1, 2020, continuing through the rest of the COVID-19 PHE period
ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification
CMS requires a positive COVID-19 test in order for these Medicare claims to be eligible for the $20 %$ increase in Medicare Severity DRG weighting factor.7
# Coding for NCTAP1
For hospital discharges for claims beginning January 1, 2021, through the duration of the COVID-19 PHE, the following Olumiant ICD-10-PCS codes can be used:
| | |
| --- | --- |
| XWODXM6 | Introduction of baricitinib into mouth and pharynx,external approach, new technology group 6 |
| XW0G7M6 | Intrhduction oguarctintoupgrGl i aturalortfialipgenig ne |
# DID YOU KNOW?
Olumiant is available as 4mg, 2mg, and 1mg tablets for the treatment of COVID-19 in inpatient facilities.8
Click here for more information.
# SELECT IMPORTANT SAFETY INFORMATION RELATED TO TUBERCULOSIS
Evaluate patients for active infection prior to initiating Olumiant. Olumiant should not be given to patients with active TB. Monitor patients for development of signs and symptoms of TB, including patients who tested negative for latent TB prior to initiating therapy.
Please see Important Safety Information, including Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis on page 6-9. Please click to access Prescribing Information and Medication Guide.
# In 2017, commercial rates for inpatient services were 89% higher than Medicare’s FFS rates on average9
# For all 3 respiratory diagnoses related to COVID-19, private insurance paid more than double when compared to Medicare10
• For patients on a ventilator for more than 96 hours, the average private insurance payment rate was about $$ 60,000$ more than the average amount paid by Medicare • Private insurance reimbursement for services related to COVID-19 were between 2.1 and 2.5 times higher than average Medicare reimbursement
# DID YOU KNOW?
The CARES ACT Provider Relief Fund provides support for COVID-19 care or treatment for uninsured individuals, including claims for reimbursement for care or treatment related to:
• Positive diagnoses of COVID-19 where COVID-19 is the primary reason for treatment
• Administering COVID-19 vaccinations provided to individuals who do not have any healthcare coverage at the time the services are provided
Healthcare providers will generally be reimbursed at Medicare rates, subject to available funding.11
# IMPORTANT SAFETY INFORMATION
# WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS
# SERIOUS INFECTIONS
Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:
• Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use. • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. • Bacterial, viral, and other infections due to opportunistic pathogens.
Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
The risks and benefits of treatment with Olumiant in COVID-19 patients with other concurrent infections should be considered.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
# IMPORTANT SAFETY INFORMATION (Continued)
# MORTALITY
# In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
# MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
# MAJOR ADVERSE CARDIOVASCULAR EVENTS
In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
# THROMBOSIS
Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.
# IMPORTANT SAFETY INFORMATION (Continued)
# HYPERSENSITIVITY
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
# GASTROINTESTINAL PERFORATIONS
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
# LABORATORY ABNORMALITIES
Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count $\\mathsf { \\Pi } \[ \\mathsf { A N C } \] < 1 0 0 0 \\mathsf { c e l } \| \\mathsf { s } / \\mathsf { m m } ^ { 3 } )$ compared to placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an $\\mathsf { A N C } < 1 0 0 0 { \\mathsf { c e l l s } } / { \\mathsf { m m } } ^ { 3 } .$ In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an $\\mathsf { A N C } < 5 0 0 { \\mathsf { c e l l s } } / { \\mathsf { m m } } ^ { 3 }$ .
Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. In patients with COVID-19, avoid initiation or interrupt Olumiant treatment in patients with an ALC <200 cells/mm3.
Anemia – Decreases in hemoglobin levels to $< 8 \\mathrm { g / d L }$ were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management.
In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin ${ < } 8 \\mathrm { g } / \\mathrm { d } L$ . In patients with COVID-19, there is limited information regarding use of Olumiant in patients with hemoglobin less than $8 \\mathrm { g } / \\mathrm { d L }$ .
Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) $2 5 \\times$ upper limit of normal (ULN) and increases of aspartate transaminase (AST) ${ \\ge } 1 0 \\times$ ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and druginduced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
# IMPORTANT SAFETY INFORMATION (Continued)
# VACCINATIONS
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
# ADVERSE REACTIONS
In COVID-19 trials, the most common adverse reactions $( \\geq 1 % )$ reported with Olumiant were: ALT $2 3 x$ ULN, AST $2 3 x$ ULN, thrombocytosis (platelets $> 6 0 0 , 0 0 0 \\mathsf { c e l l s / m m } ^ { 3 } )$ , creatine phosphokinase $> 5 \\mathsf { x }$ ULN, neutropenia (ANC <1000 cells/ $' \\mathrm { m } \\mathrm { m } ^ { 3 } .$ ), DVT, PE, and urinary tract infection.
# PREGNANCY AND LACTATION
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
# HEPATIC AND RENAL IMPAIRMENT
Olumiant should only be used in patients with COVID-19 and severe hepatic impairment if the potential benefit outweighs the potential risk. Olumiant is not recommended in patients with COVID-19 who are on dialysis, have end-stage renal disease, or with eGFR <15 mL/min/1.73m2.
# Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide.
# BA HCP ISI COV 13JUN2022
# References
1. Centers for Medicare & Medicaid Services. New COVID-19 Treatments Add-On Payment (NCTAP). [https://www.cms.gov/medicare/](https://www.cms.gov/medicare/) covid-19/new-covid-19-treatments-add-payment-nctap. Updated January 27, 2021. Accessed January 31, 2021. 2. Centers for Medicare & Medicaid Services. COVID-19 frequently asked questions (FAQs) on Medicare fee-for-service (FFS) billing. [https://www.cms.gov/](https://www.cms.gov/) files/document/03092020-covid-19-faqs-508.pdf. Updated July 2, 2021. Accessed July 22, 2021. 3. Congressional Research Service. Medicaid’s federal medical assistance percentage (FMAP). [https://fas.org/sgp/crs/misc/R43847.pdf](https://fas.org/sgp/crs/misc/R43847.pdf). Updated July 29, 2020. Accessed February 17, 2021. 4. Centers for Medicare & Medicaid Services. Design and development of the diagnosis related group (DRG). https:// [www.cms.gov/icd10m/version37-fullcode-cms/fullcode\_cms/Design\_and\_development\_of\_the\_Diagnosis\_Related\_Group\_(DRGs).pdf](http://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/Design_and_development_of_the_Diagnosis_Related_Group_(DRGs).pdf). Published October 1, 2019. Accessed February 17, 2021. 5. Lewis M. Medicare reimbursement for drugs and devices. In: Emerging Life Sciences Companies. 2nd ed. Philadelphia, PA: Morgan, Lewis & Bockius; 2008:138-148. 6. Cunningham P, Rudowitz R, Young K, Garfield R, Foutz J. Understanding Medicaid hospital payments and the impact of recent policy changes. [https://www.kff.org/report-section/understanding-medicaid-hospital-payments-and-the-impact-ofrecent-policy-changes-issue-brief/](https://www.kff.org/report-section/understanding-medicaid-hospital-payments-and-the-impact-ofrecent-policy-changes-issue-brief/). Published June 9, 2016. Accessed February 17, 2021. 7. Fletcher T. CMS to require positive COVID-19 test results for 20-percent Medicare add-on payment. [https://www.icd10monitor.com/cms-to-require-positive-covid-19-test-results-for-20-percent-medicareadd-on-payment](https://www.icd10monitor.com/cms-to-require-positive-covid-19-test-results-for-20-percent-medicareadd-on-payment). Updated September 1, 2020. Accessed February 19, 2021. 8. Eli Lilly and Company. Access. [https://www.covid19.lilly.com/baricitinib](https://www.covid19.lilly.com/baricitinib) hcp/access. Accessed February 23, 2021. 9. Congressional Budget Office. An analysis of hospital prices for commercial and Medicare Advantage plans. [https://www.cbo.gov/publication/52819](https://www.cbo.gov/publication/52819). Published June 26, 2017. Accessed February 17, 2021. 10. Lopez E, Claxton G, Schwartz K, Rae M, Ochieng N, Neuman T. Comparing private payer and Medicare payment rates for select inpatient hospital services. [https://www.kff.org/report-section/comparingprivate-payer-and-medicare-payment-rates-for-select-inpatient-hospital-services-methods/](https://www.kff.org/report-section/comparingprivate-payer-and-medicare-payment-rates-for-select-inpatient-hospital-services-methods/). Published July 7, 2020. Accessed February 17, 2021 11. Health Resources & Services Administration. COVID-19 claims reimbursement to health care providers and facilities for testing, treatment, and vaccine administration for the uninsured. [https://www.hrsa.gov/coviduninsuredclaim](https://www.hrsa.gov/coviduninsuredclaim). Updated June 2021. Accessed July 22, 2021.
# Please see Important Safety Information, including Boxed Warning for Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis on page 6-9. Please click to access Prescribing Information and Medication Guide.
## Medical Necessity Guide
# Letter of Medical Necessity Guide
The following information is presented for informational purposes only and is not intended to provide reimbursement or legal advice. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. Providers are encouraged to contact the patient’s health plan for specific information on their coverage policies. For more information, please call Lilly Support Services™ for Olumiant® at 1-800-LillyRx (1-800-545-5979).
# Composing a Letter of Medical Necessity Guide
The purpose of a Letter of Medical Necessity (LMN) is to explain the prescribing healthcare provider’s (HCP’s) rationale and clinical decision-making for choosing treatment.\* Many health plans require that an LMN accompany submissions of Appeal, Formulary Exception Request, and Tiering Exception Request Letters.
This resource, Letter of Medical Necessity Guide, provides information on the process of drafting an LMN. The sample letter attached to this document features information that plans often require. Note that some plans have specific forms that must be utilized to document an LMN. Follow the patient’s plan requirements when requesting Olumiant® (baricitinib) otherwise, treatment initiation may be delayed.
If interested in using alternative appeals resources, see available LMN examples from the National Alopecia Areata Foundation (NAAF
# Common clinical evidence required for Letters of Medical Necessity includes:
• Patient’s condition (diagnosis/diagnoses), International Classification of Diseases, Tenth Revision (ICD-10) code, and assessment of severity of disease fo which Olumiant is being/will be used, including:
‒ Severity of Alopecia Tool (SALT) score ‒ alternative disease severity classification tool(s) ‒ recent history of infection(s), along with any allergies and existing comorbidities Information about the current treatment(s) being used for the patient’s condition and how the patient is presenting clinically while taking the current treatment(s) • Previous therapies used, dates used, and reasons for discontinuation (if applicable) • Clinical rationale for why other treatments are not appropriate, if applicable • Clinically relevant and patient-specific information that makes Olumiant an appropriate therapy for the patient
# Lilly Support Services™ will work with you to help navigate patient access
For more information, please visit [https://olumiant.lilly.com/hcp/support-resources](https://olumiant.lilly.com/hcp/support-resources) or call Lilly Support Services™ at 1-800-LillyRx (1-800-545-5979).
# INDICATION
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
# SELECT IMPORTANT SAFETY INFORMATION: WARNING RELATED TO SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS
SERIOUS INFECTIONS: Olumiant-treated patients are at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment with Olumiant if a serious infection occurs until the infection is controlled. Olumiant should not be given to patients with active tuberculosis. Test for latent TB before and during therapy, except for COVID-19; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
ORTALITY: Higher rate of all-cause mortality, including sudden cardiovascular death was observed with another Janus kinase (JAK) inhibitor vs. tumor ecrosis factor (TNF) blockers in rheumatoid arthritis (RA) patients.
ALIGNANCIES: Malignancies have also occurred in patients treated with Olumiant. Higher rate of lymphomas and lung cancers was observed with anoth AK inhibitor vs. TNF blockers in RA patients.
MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE): Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.
THROMBOSIS: Thrombosis has occurred in patients treated with Olumiant. Increased incidence of pulmonary embolism, venous and arterial hrombosis was observed with another JAK inhibitor vs. TNF blockers.
lease see Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, nd Thrombosis on Pages 4-5. Please click to access Prescribing Information and Medication Guide.
# Letter of Medical Necessity Guide
This template can be used by HCPs for explaining medical necessity.
Click here to access an exportable Microsoft Word document for use on your office letterhead.
Please see Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis on Pages 4-5. Please click to access Prescribing Information and Medication Guide.
# Letter of Medical Necessity Guide
This template can be used by HCPs for explaining medical necessity.
Sample Letter of Medical Necessity for Olumiant with instructions
Based on my professional experience, treatment with Olumiant is appropriate, medically necessary, and supported by their individual medical history. Attached are medical records to support my rationale.
If you have any additional questions, please contact me at or via email at . Thank you for your time and consideration.
Sincerely,
Enclosed:
Please see Important Safety Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis on Pages 4-5. Please click to access Prescribing Information and Medication Guide.
# Indication and Important Safety Information
# INDICATION
Olumiant is a Janus kinase (JAK) inhibitor indicated for the treatment of adult patients with severe alopecia areata.
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or othe potent immunosuppressants.
# IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS
SERIOUS INFECTIONS - Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients with rheumatoid arthritis (RA) who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:
• Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Olumiant should not be given to patients with active tuberculosis. Test patients, except those with COVID-19, for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use. • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. • Bacterial, viral, and other infections due to opportunistic pathogens
Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
The most common serious infections reported with Olumiant included pneumonia, herpes zoster, and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus, and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than localized disease, and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Avoid use of Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients: with chronic or recurrent infection; who have been exposed to TB; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
Consider anti-TB therapy prior to initiation of Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection.
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves. The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.
# MORTALITY
In a large, randomized, postmarketing safety study in RA patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant.
# MALIGNANCIES
Lymphoma and other malignancies have been observed in patients treated with Olumiant. In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer \[NMSC\]) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers and an additional increased risk of overall malignancies were observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients with a known malignancy (other than successfully treated NMSC), patients who develop a malignancy, and patients who are current or past smokers.
NMSCs have been reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
# MAJOR ADVERSE CARDIOVASCULAR EVENTS
In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction \[MI\], and stroke) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue Olumiant in patients that have experienced a myocardial infarction or stroke.
Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with Olumiant, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Inform patients about the symptoms of serious cardiovascular events and the steps to take if they occur.
# IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) tablets (Cont’d)
# A LillyMedicine
# THROMBOSIS
Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid Olumiant in patients at risk. Discontinue Olumiant and promptly evaluate patients with symptoms of thrombosis.
# HYPERSENSITIVITY
Reactions such as angioedema, urticaria, and rash that may reflect drug hypersensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.
# GASTROINTESTINAL PERFORATIONS
Gastrointestinal perforations have been reported in Olumiant clinical studies. Monitor Olumiant-treated patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.
# LABORATORY ABNORMALITIES
Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count \[ANC\] <1000 cells $' \\mathrm { m m } ^ { 3 }$ ) compared to placebo. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or alopecia areata (AA), avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3.
Lymphopenia – Absolute lymphocyte count (ALC) $< 5 0 0$ cells $\\mathsf { m m } ^ { 3 }$ were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with an ALC $< 5 0 0$ cells/mm3.
Anemia – Decreases in hemoglobin levels to $< 8 \\mathrm { g / d L }$ were reported in Olumiant clinical trials. Evaluate at baseline and thereafter according to routine patient management. In patients with RA or AA, avoid initiation or interrupt Olumiant treatment in patients with hemoglobin ${ < } 8 \\mathrm { g } / \\mathrm { d } L$ .
Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of alanine transaminase (ALT) $\\ge 5 \\times$ upper limit of normal (ULN) and increases of aspartate transaminase (AST) ${ \\geq } 1 0 \\times$ ULN were observed in patients in Olumiant clinical trials.
Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.
Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation in patients with RA or AA. Manage patients according to clinical guidelines for the management of hyperlipidemia.
# VACCINATIONS
Avoid use of live vaccines with Olumiant. Update immunizations in patients with RA or AA prior to initiating Olumiant therapy in agreement with current immunization guidelines.
# ADVERSE REACTIONS
In RA trials, the most common adverse reactions $( \\ge 1 % )$ reported with Olumiant were: upper respiratory tract infections, nausea, herpes simplex, and herpes zoster.
In AA trials, the most common adverse reactions $( \\geq 1 % )$ reported with Olumiant were: upper respiratory tract infections, headache, acne, hyperlipidemia, creatine phosphokinase increase, urinary tract infection, liver enzyme elevations, folliculitis, fatigue, lower respiratory tract infections, nausea, genital Candida infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight increase.
# PREGNANCY AND LACTATION
Based on animal studies, Olumiant may cause fetal harm when administered during pregnancy. Advise pregnant women and women of reproductive potential of the potential risk to a fetus. Consider pregnancy planning and prevention for women of reproductive potential. Advise women not to breastfeed during treatment with Olumiant and for 4 days after the last dose.
# HEPATIC AND RENAL IMPAIRMENT
Olumiant is not recommended in patients with RA or AA and severe hepatic impairment or severe renal impairment (estimated glomerular filtration rate \[eGFR\] <30 mL/min/1.73m2).
# BA HCP ISI RA-AA 14SEP2022
Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events, and Thrombosis, and Medication Guide.
Sample Letter of Medical Necessity for Olumiant® (baricitinib)
ATTN:
Re: Letter of Medical Necessity for Olumiant® (baricitinib)
To Whom It May Concern:
I am writing to request coverage for Olumiant, a medically necessary treatment that I have prescribed for .
This letter includes information about my patient’s medical history along with my rationale for prescribing Olumiant.
Medical History
# Treatment History
Clinical Rationale
am requesting renewal of coverage for my patient, who has been taking Olumiant since and has shown clinical improvemen I have included documentation of positive clinical response.
Please note, the patient will not be taking Olumiant in combination with another biologic therapy or JAK (Janus kinase) inhibitor.
Based on my professional experience, treatment with Olumiant is appropriate, medically necessary, and supported by their ndividual medical history. Attached are medical records to support my rationale.
If you have any additional questions, please contact me at or via email at . Thank you for your time and consideration.
Sincerely,
nclosed:
## Olumiant Enrollment Form
# Olumiant® (baricitinib) Dermatology ENROLLMENT FORM
PUBLISHED 06/2025
To prevent delays in getting your Patient started, please complete in full. Items with † are required to complete enrollment. Upon completion, submit pages 1-4 via fax at 1-844-658-4268 or upload online at patientsupportnow.org and code 844658426
# THIS PAGE MUST BE SUBMITTED
# SECTION 1: PATIENT INFORMATION
Patient Name† (First, MI, Last) Patient DOB† (MM/DD/YYYY)
Address† City† State† Zip†
Gender† M F referred Language English Spanish Other Email
Phone†\* (000-000-0000) Preferred Contact: Phone Call Text Email
By providing Lilly with your cell phone number and email address with the consent below, you can conveniently receive updates and status changes about your enrollment.
\*By checking the box, I agree to receive automated marketing calls and texts from and on behalf of Eli Lilly and Company. I understand that I am not required to provide my number as a condition of receiving goods and services. Message and data rates may apply.
By checking the box, I agree to be contacted to: provide feedback on my experience with the related products, services, and programs; to share my story; and, to participate in market and medical research studies about products and services.
HIPAA AUTHORIZATION NEEDED: PATIENT SIGNATURE REQUIRED AT BOTTOM OF PAGE 4 FOR ENROLLMENT
# SECTION 2: INSURANCE INFORMATION
# SECTION 3: SERVICE SELECTION
Please select if you would like to enroll by checking the corresponding checkbox below. By enrolling in the service below, you are agreeing to the Terms of Participation and consenting to the collection of your information, inclusive of health information as described under the Privacy Notice on page 6.
1. Savings Card: Provides eligible, commercially-insured Patients with options to save on treatment costs SAVINGS CARD ELIGIBILITY (must confirm the below statements in order to be eligible)
I confirm that I am a resident of the United States or Puerto Rico who is 18 years of age or older I confirm that I am NOT enrolled in a government-funded healthcare program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state prescription drug assistance program
# TERMS OF PARTICIPATION AND PROGRAM DISCLOSURES:
Your healthcare provider has talked with you about using Olumiant®, an Eli Lilly and Company medicine. Lilly Support Services™ for Olumiant® offers personalized support to Patients at no charge and was created to help you have a positive experience as you get started with and use this medicine. By checking the corresponding optional boxes above, you consent to your enrollment into Lilly Support Services™ for Olumiant®. As part of your participation in Lilly Support Services™ for Olumiant®, you understand and authorize Lilly USA, LLC to retain and use your personal information for the purposes described in this form. Eli Lilly and Company, Lilly USA, LLC and its affiliates, agents, representatives, and service providers (together “Lilly”) may use, disclose, and/or transfer the personal information you supply to provide services related to your condition and treatment to administer the program. The Lilly Support Services™ for Olumiant® Support team can contact you by email, mail or telephone to provide personalized services and information and materials directly related to your condition and therapy; responding to customer service requests and/or questions about your treatment; disclosing your enrollments and use of these services to your doctors and insurers; analyzing and/or measuring program performance and program effectiveness for future enhancements; and other activities related to your condition and therapy that are part of Lilly Support Services™ for Olumiant®. Your personal information, including information that may be related to your health, is needed to fulfill your request. To cancel your participation in the program, please contact us at 1-800-LillyRx (1-800-545-5979) Monday-Friday, 8am -10pm ET. For information about Lilly's privacy practices, please see our Privacy Statement at [https://privacynotice.lilly.com](https://privacynotice.lilly.com/) and the Consumer Health Privacy Notice at [https://www.lillyhub.com/legal/lillyusa/CHPN.html](https://www.lillyhub.com/legal/lillyusa/CHPN.html).
# Olumiant® (baricitinib) Dermatology ENROLLMENT FORM
PUBLISHED 06/2025
# THIS PAGE MUST BE SUBMITTED
# SECTION 4: PRESCRIBER INFORMATION
Prescriber Name (First, Last)† NPI #† Practice Name† Office Phone† (000-000-0000) Office Fax† (000-000-0000) Office Address† Office City† Office State† Office Zip† Group Tax ID Office Contact Name Office Contact Phone (000-000-0000) Office Contact Email Collaborating Physician NPI
# SECTION 5: DIAGNOSIS
Name of Patient† (First, MI, Last) DOB† (MM/DD/YYYY) Patient Address† Patient City† Patient State† Patient Zip† Diagnosis (select one)†: L63.0 Alopecia (capitis) totalis L63.1 Alopecia universalis L63.2 Ophiasis L63.8 Other alopecia areata L63.9 Alopecia areata, unspecified Other ICD-10-CM Code
# ECTION 6: HCP SERVICE SELECTION & PRESCRIPTION
# Benefits Investigation Support (SELECT ONE)†
# Lilly Conducted Benefits Investigation–IF CHECKED, MUST FILL OUT PRESCRIPTION SECTION BELOW.
Lilly Support Services™ for Olumiant® will research the Patient’s insurance and innetwork Specialty Pharmacy options to help identify the lowest out-of-pocket cost available for Olumiant® and will forward the prescription to the Specialty Pharmacy that the Patient selects. A Lilly Support Services™ for Olumiant® representative will help triage and troubleshoot access issues on the Patient’s behalf.
# OR
# Specialty Pharmacy Conducted Benefits Investigation– IF CHECKED, MUST COMPLETE FIELDS BELOW.
Specialty Pharmacy where prescription was sent
Specialty Pharmacy Phone Number (000-000-0000)
# Olumiant® Dermatology Prescription — Fill out corresponding prescription below and sign at the bottom of page
| | | | |
| --- | --- | --- | --- |
| DOSING | QUANTITY | DAY SUPPLY | REFILLS |
| Olumiant?2 mg tablet,once daily by mouth. | 30 | 30 | (1-11) |
| Olumiant@ 4 mg tablet,once daily by mouth. | | 30 | (1-11) |
| Olumiant@ 1 mg tablet,once daily by mouth for Patients with moderate renal impairment or who are taking strong OAT3 inhibitors. | 30 30 | 30 | (1-11) |
Prior Treatment (select all that apply)
By signing below, I certify: 1) The therapy is medically necessary and that this information is accurate to the best of my knowledge; 2) I am disclosing this information to Eli Lilly and Company, Lilly USA, LLC, their affiliates, agents, representatives, business partners, and service providers (together “Lilly”) to help enable treatment for this Patient; 3) The Patient is aware of, has consented to, and has directed my disclosure of their information to Lilly so that Lilly may contact the Patient to further enable services for those purposes and that such consent and direction applies to disclosures made through the duration of the Patient’s therapy; 4) I will not seek reimbursement from any third party for the support Lilly provides; and 5) I am licensed to prescribe the prescription medication identified in this form, the prescription complies with my state specific prescribing requirements and I appoint Lilly as my agent for the limited purposes of conveying this prescription by facsimile only to the dispensing pharmacy. I understand that by signing this form, I am requesting support from Eli Lilly and Company for Patients receiving Olumiant® pursuant to an FDA approved indication. PRESCRIBER SIGNATURE: PRESCRIBER MUST MANUALLY SIGN AND DATE. Rubber stamps, signature by other office personnel for the Prescriber, and computer-generated signatures will not be accepted.
Dispense as written† May substitute/brand exchange permitted Not signing this form will result in an incomplete submission and a delay in requested services
Date Signed† (MM/DD/YYYY)
# Olumiant® (baricitinib) Dermatology ENROLLMENT FORM
PUBLISHED 06/2025
# HIPAA AUTHORIZATION
# THIS PAGE MUST BE SUBMITTED
You have selected Eli Lilly and Company (“Lilly”) to coordinate certain services related to your health and to provide information related to your health (Lilly’s “Programs and Services”). In order for Lilly to offer the Programs and Services, Lilly may need to obtain or exchange your protected health information (“PHI”) as defined under the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”) from your Health Care Entities (as defined below). PHI can be inclusive of “sensitive data” as defined by applicable U.S. privacy laws. After your PHI has been released to Lilly, it is no longer covered by HIPAA. By signing this form, you understand and authorize your Health Care Entities to share your PHI with Lilly and use as explained below.
# PHI includes the following individually identifiable information:
• Information about your health insurance or benefits, including how much coverage you have
• All relevant records about your treatment, including medication histories and prescriptions
• Information about your payment for treatment, including any insurance coverage
• Whether you’re staying on your medicine or treatment
# If you agree, your PHI may be collected from and shared by these entities (together “Health Care Entities”):
• Your doctors and other healthcare providers
• Your healthcare plan or health insurance company
• Clearinghouses or other agents
• Your pharmacy
• Others who might have your PHI on behalf of your healthcare providers, pharmacies and healthcare plans
# How Your PHI Will Be Used
Your PHI will be used to enroll you in, provide you with, and operate and administer the Programs and Services, consistent with Lilly’s Privacy Statement and Consumer Health Privacy Notice, including to:
• understand how much of your Lilly treatment is covered by your insurance
• help you find ways to afford such treatment
• track the shipment, receipt, and use of your Lilly treatment and Programs and Services
• share information with your Health Care Entities and communicate with them regarding Lilly Programs and Services
• contact you about Lilly Programs and Services related to your health needs
• measure Lilly Programs and Services’ performance in order to make improvements and drive business decisions and metrics
• de-identify your data for analytics including reports about Health Care Entities’ use of Lilly Programs and Services.
# Olumiant® (baricitinib) Dermatology ENROLLMENT FORM
PUBLISHED 06/2025
# HIPAA AUTHORIZATION
# THIS PAGE MUST BE SUBMITTED
# Other things you should know about how we may use and share your PHI:
We do not ask for any PHI that we do not need, but we may receive some in the health records sent to us. Your PHI will be released to Lilly and its wholly owned subsidiaries (“Lilly” or “we”) and/or entities or persons that work on behalf of, or in partnership with, Lilly but are not Lilly employees (“Third Parties”).
• You don’t have to give permission to share your PHI with Lilly to receive treatment from your Health Care Entities, your prescription from your pharmacy, or benefits from your healthcare plan, but Lilly Programs and Services may not be able to help you without your Authorization.
• Your Health Care Entities may receive compensation from us in exchange for sharing your PHI. They may also be paid by us to use your PHI to provide services, such as contacting you about Lilly products.
• Your signed authorization to share and use your PHI lasts for the duration of your participation in Lilly Programs and Services from the date of your signature or earlier as required by state law. In any case, you may revoke this Authorization for Lilly Programs and Services and you may request to obtain PHI from your Health Care Entities at any time by writing to PO Box 221349, Charlotte, NC 28222. Your revocation of this Authorization will not have any effect on any uses or disclosures of your PHI that occurred prior to Lilly’s receipt of your revocation.
• Your revocation of this Authorization will be effective when your Health Care Entities receive notice of your cancellation or revocation and will not apply to any information shared with Lilly prior to receipt of the notice.
AUTHORIZATION TO USE AND DISCLOSE PROTECTED HEALTH INFORMATION: I authorize my Health Care Entities to disclose my PHI and sensitive data for the purposes as described in this HIPAA Authorization. This HIPAA Authorization replaces any prior HIPAA Authorizations that I may have provided at a specific program level.
By signing this form, I attest that I have read and agree to the Patient HIPAA Authorization.
I understand I am entitled to a copy of this signed Authorization.
# SIGN and DATE
Signature of Patient†
Not signing this form will result in an incomplete submission and a delay in requested services
Printed Name of Patient
Signature Date† (MM/DD/YYYY)
Date of Birth (MM/DD/YYYY)
# Olumiant® (baricitinib) Dermatology ENROLLMENT FORM
# SAVINGS CARD TERMS AND CONDITIONS
By enrolling in the Olumiant Savings Card Program (“Program”) and using the Olumiant Savings Card (“Card”), you attest that you meet the eligibility criteria, agree to, and will comply with the terms and conditions described below:
# Card Eligibility:
(1.) You have been prescribed Olumiant® (baricitinib) for an approved use consistent with FDA-approved product labeling;
(2.) You are enrolled in a commercial drug insurance plan;
(3.) You are not enrolled in any state, federal, or government funded healthcare program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medicare Advantage, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any state prescription drug assistance program;
(4.) You are a resident of the United States or Puerto Rico; and
(5.) You are 18 years of age or older.
# Card Terms and Conditions:
For patients with commercial drug insurance coverage for Olumiant: You must have commercial drug insurance that covers Olumiant and a prescription for an approved use consistent with FDA-approved product labeling to pay as little as $$ 5$ for a 1-month prescription fill of Olumiant. Month is defined as 30 days. Card must be first used by no later than 12/31/2025. Card savings are subject to a maximum monthly savings of wholesale acquisition cost plus usual and customary pharmacy charges and a separate maximum annual savings of up to $$ 9,200$ per calendar year. Card may be used for up to a maximum of 13 prescription fills per calendar year and up to a maximum of 24 prescription fills over the lifetime of the Program, subject to the previously stated maximum monthly and annual savings limit. Except where prohibited by applicable state law, Card monthly and annual savings are reduced if Lilly identifies that you are enrolled in a plan or program, sometimes called a maximizer plan, that adjusts your cost sharing amount to be equal to or include some portion of the savings provided by the Card and attempts to prevent the savings from this Card from being applied to your out-of-pocket costs, including but not limited to copayments, coinsurances, and deductibles (“Maximizer”). If the Program identifies you are enrolled in a Maximizer, Card savings are reduced to a maximum annual savings of up to $$ 6000$ per calendar year. If you have reason to believe that the Program erroneously identified enrollment in a Maximizer, please call the Olumiant Savings Card Program at 1-800-LillyRx (1-800-545-5979). Participation in the Program requires a valid patient HIPAA authorization upon enrollment into the Program. Subject to Lilly USA, LLC’s right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card terms and conditions which may occur at Lilly’s sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
For patients with commercial drug insurance who do not have coverage for Olumiant: You must have commercial drug insurance that does not cover Olumiant and a prescription for an approved use consistent with FDA-approved product labeling to pay as little as $$ 25$ for a 1-month supply of Olumiant. Month is defined as 30 days. Card must be first used by no later than 12/31/2025. Card savings are subject to monthly savings and a separate maximum annual savings. Card may be used for up to a ma of 13 prescription fills per year and up to a maximum 24 prescription fills over the lifetime of the Program, subject to the maximum monthly and annual savings limit. rd must be first used by no later than 12/31/2025. Participation in the Program requires submission of a prior authorization (PA) prior to the rescription fill. If cover is denied, an appeal must be submitted prior to $5 ^ { \\mathrm { t h } }$ month prescription fill. To remain eligible for the Program, a new ppea dical exceptio t be submitted prior to the 13th prescription fill and as required by Lilly at its sole discretion. Participation in the Progr patient HIPAA o remain in the Program. Subject to Lilly USA, LLC’s right to terminate, rescind, revoke, or amend Card eligibility criteria and/or Card ter ms and conditions, which may occur at Lilly’s sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
# Additional Program Terms and Conditions
If you have an insurance plan that is participating in an alternate funding program (“AFP”) that requires you to apply to the Olumiant Savings Card Program or otherwise pursue specialty drug prescription coverage through an alternate funding vendor as a condition of, requirement for, or prerequisite to coverage of Olumiant, you are not eligible for and are prohibited from using the Olumiant Savings Card Program. AFPs include programs where coverage, reimbursement, or patient out of pocket costs for a product in some way vary based on the availability of a manufacturer co-pay program. AFPs may modify, delay, deny, restrict, or withhold insurance benefits or coverage from patients, or exclude Lilly products from coverage contingent upon a member’s use of Olumiant Savings Card Program. You agree to inform Olumiant Savings Card Program if you are or become a member of such an alternative funding program. You are responsible for any applicable taxes, fees, and any amount that exceeds the applicable monthly or annual maximum Card savings. Monthly and annual maximum savings are set at Lilly’s sole and absolute discretion and may be changed with or without notice at any time for any reason. At its sole discretion and with or without notice, Lilly may reduce, eliminate, or otherwise modify the Card savings for any reason, including but not limited to if your commercial drug insurance plan imposes additional requirements which limits or prevents you from receiving coverage for Olumiant, only allows partial coverage for Olumiant, removes coverage for Olumiant and requires you to utilize the Card, does not provide a material level of financial assistance for the cost of Olumiant, or does not apply Card payments to satisfy your co-payment, deductible, or coinsurance for Olumiant. Card savings are not valid for: Massachusetts residents if an AB-rated generic equivalent is available; California residents if an FDA-approved therapeutic equivalent is available. You must meet the Card eligibility criteria, terms and conditions every time you use the Card. If at any time you begin receiving drug coverage under any state, federal, or government funded healthcare program, you understand that you will no longer be eligible for the Olumiant Savings Card and agree to call the Olumiant Savings Card Program at 1-800-LillyRx (1-800-545-5979) to stop participation. Card activation is required. You may not seek reimbursement from your health insurance, any third party, or any health savings, flexible spending, or other healthcare reimbursement accounts, for any amount of the savings received through the Card. By utilizing the Card, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you will notify your Insurance Carrier of your redemption of the Card. Card savings cannot be combined or utilized with any other program, discount, discount card, cash discount card, coupon, incentive, or similar offer involving Olumiant. You agree that this Card savings is intended solely for the benefit of you, the patient, and that the Card benefits are nontransferable. It is prohibited for any person to sell, purchase, or trade; or to offer to sell, purchase, or trade, or to counterfeit the Card. THIS CARD IS NOT INSURANCE. Lilly has the sole right to interpret and apply Card eligibility criteria, and terms and conditions. Card eligibility, and terms and conditions may be terminated, rescinded, revoked, or amended by Lilly at any time without notice and for any reason. Lilly’s sole discretion to terminate, rescind, revoke, or amend Card eligibility and/or Card terms and conditions includes the right to terminate any individual Card if Lilly determines, in its sole discretion, that a patient does not satisfy the Card’s eligibility criteria or is using or has attempted to use the Card inconsistently with these terms and conditions. Eligibility criteria, and terms and conditions for the Olumiant Savings Card Program may change from time to time; the most current version can be found at [https://www.olumiant](https://www.olumiant/). lilly.com/savings-support. You may be required to obtain a new Card, including if any Card terms and conditions have been terminated, rescinded, revoked, or amended by Lilly. Card void where prohibited by law. Subject to Lilly’s right to terminate, rescind, revoke or amend Card eligibility criteria and/or Card terms and conditions, which may occur at Lilly’s sole discretion, without notice, and for any reason. Card expires and savings end on 12/31/2027 or 24 months after you first use the Card, whichever comes first.
# Olumiant® (baricitinib) Dermatology ENROLLMENT FORM
PUBLISHED 06/2025
# PRIVACY NOTICE
This Privacy Notice (“Notice”) is intended to supplement the Eli Lilly and Company Privacy Statement ( [https://privacynotice.lilly.com](https://privacynotice.lilly.com/)) and the Consumer Health Privacy Notice ( [https://www.lillyhub.com/legal/lillyusa/CHPN.html](https://www.lillyhub.com/legal/lillyusa/CHPN.html)) that can be accessed in the footers of Lilly’s websites. This Notice is to provide you with information about the personal information, including health information, we may collect, use, disclose or otherwise process, and your rights and choices with respect to your information.
The categories of health information we collect will depend on how you interact with Lilly Services and the information you choose to provide We may collect:
• Health conditions, treatments, diseases, or diagnosis • Social, psychological, behavioral, and medical interventions • Health-related surgeries or procedures • Use or purchase of prescribed medication • Bodily functions, vital signs, symptoms, or measurements of other types of consumer health data • Diagnoses or diagnostic testing, treatment, or medication
• Reproductive or sexual health information
• Biometric data
• Genetic data
• Data that identifies a consumer seeking health care services • Other information that may be used to infer or derive data related to the above or other health information.
With your consent, we may use the health information we collect for the following purposes, as further described in our privacy statements:
• Providing Services and support.
• Analytics and improvement.
• Customization and personalization.
• Marketing and advertising. • Security and protection of rights.
• Legal proceedings and obligations.
• General business and operational support.
illy does not sell or share your health information with third parties without your consent or authorization. We may disclose health information o our processors for our business purposes or at your direction to provide you with products and Services that you request.
We may use and save your personal information to meet legal or regulatory obligations that are in the legitimate interest of Lilly, to fulfill legitimate and lawful business purposes in accordance with Lilly’s record retention policies and applicable laws and regulations, and to respond to lawful requests by public authorities, including to comply with national security or law enforcement requests.
Some of this personal information may be considered sensitive under applicable laws, such as information about your health or medical diagnosis and demographic information collected in some circumstances, such as race, ethnic origin, and sexual orientation. We may process your sensitive PI with your consent, or as otherwise permitted by law.
Upon verification, you have rights with respect to the collection, use and storage of your information. These rights may include access to your information and how it is being used or shared, the right to correct, delete or limit use of your information or to withdraw consent for us to collect and use your information. There may be certain exceptions and limitations that apply to your request including the right to have your information transmitted to another entity or person in a machine-readable format. To exercise your rights, you or your authorized representative may submit a request to [datarights@lilly.com](mailto:datarights@lilly.com) or 1-800-Lilly-Rx (1-800-545-5979). You will not be discriminated against for exercising any of your rights. You may be entitled, in accordance with applicable law, to appeal a refusal to take action on your request. To do so, please contact us by using one of the methods listed here or in How to Contact Us section of the online Privacy Statement.
If you wish to raise a complaint on how we have handled your personal information, you can contact the Global Privacy Office and Data Protection Officer at [privacy@lilly.com](mailto:privacy@lilly.com), who will investigate the matter. If you are not satisfied with our response or have any concerns about how your data is being processed, you can register a complaint with a relevant regulatory authority (e.g., a Data Protection Authority (DPA) or Attorney General).
## Olumiant Distributor Network
# Olumiant Inpatient Distribution Network
You can take an active role in ensuring the security of the pharmaceutical supply chain by sourcing products only from Authorized Distributors that have entered into distribution agreements with Eli Lilly and Company (Lilly).
# Olumiant Distribution Network
| | |
| --- | --- |
| Authorized Lilly Specialty Distributors\* | Contact Information |
| AmerisourceBergen Specialty Group | ASD Healthcare p: 800-746-6273 f: 800-547-9413 https://www.asdhealthcare.com/ |
| Cardinal Health Specialty Pharmaceutical Distribution | Hospitals p: 866-476-1340 f: 888-345-4916 https://www.cardinalhealth.com/specialtyonline |
| Cardinal Health Puerto Rico | Hospitals - PR p: 787-625-4244 f: 787-625-4398 https://cardinalhealth.pr |
| McKesson Specialty Care Distribution Corporation | McKesson Plasma and Biologics p: 877-625-2566 f: 888-752-7626 https://Connect.mckesson.com |
| Drogueria Betances (Puerto Rico) | Institutional Sales p: 787-653-0998 f: 787-744-7773 https://www.drogueriabetances.com/ |
\*Table current as of 08/10/2022. Please click to access full Prescribing Information, including Boxed Warning and Medication Guide.
## Olumiant Savings Card
# ENHANCED SPECIALTY PHARMACY PARTNERS
# Olumiant Savings Card
Table current as of 02/19/2024. Please go to olumiant.lilly.com for the most updated information.
Lilly Support Services™ for Olumiant® works with an enhanced network to administer the $$ 25$ card.
For more information, please visit [www.olumiant.lilly.com](http://www.olumiant.lilly.com/) or call 1-800-LillyRx (1-800-545-5979).
## Alopecia Areata Scale
# THE ALOPECIA AREATA SCALE (AASc) A MULTIDIMENSIONAL TOOL FOR ASSESSING SEVERITY OF AA1
# Primary Criterion - Severity of Scalp Hair Loss1
Mild AA
20% or less
scalp hair loss
Moderate AA 21 - 49% scalp hair loss
Severe AA 50 -100% scalp hair loss
# Secondary Criteria
If any secondary criteria are present, increase severity rating by one level.
Noticeable involvement of eyebrows or eyelashes
Inadequate response after at least 6 months of treatment
Negative impact on psychosocial functioning resulting from AA
Diffuse (multifocal) positive hair pull test consistent with rapidly progressive AA
# About the AASc
The AASc is an assessment tool designed to characterize the clinical spectrum of severity of AA. Developed and endorsed by a consensus of disease experts, the AASc incorporates a patient’s history and observed hair loss into a descriptive severity rating relevant to clinical practice. A patient’s rating on the scale is primarily based on the amount of scalp hair loss, where the rating increases if any of the secondary criteria are present.