PURPOSE AND SAFETY SUMMARY WITH WARNINGS
Important Facts About Olumiant® (O-loo-mē·ant). It is also known as baricitinib.
Olumiant 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.
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
- 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
- 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.
- 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. This may be life-threatening and cause death. Blood clots in the veins 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. While taking Olumiant, tell your doctor 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.
- 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 to check your white and red blood cells before and while you are taking Olumiant. Your doctor should also check certain liver tests. You should not take Olumiant if your blood cell counts are too low or your liver tests are too high. If your results change, your doctor may pause your treatment with Olumiant. Your doctor should also check your cholesterol approximately 12 weeks after you start this medicine and as needed after that.
- Allergic reactions. If you have symptoms, such as rash, swelling of your lips, tongue, or throat, or hives (raised, red patches of skin that are often very itchy) while taking Olumiant, stop taking Olumiant and call your doctor right away. Some of these reactions seen in patients taking Olumiant were serious.
Common side effects
The most common side effects of Olumiant include:
- upper respiratory tract infections, such as a cold or sinus infections
- cold sores
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.
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 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 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, or are breastfeeding or plan to breastfeed. You should not take Olumiant and breastfeed.
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 or take other medicines to treat rheumatoid arthritis. For example, you should not take any of the following medicines while taking Olumiant since this may increase your risk of infection:
- tocilizumab (Actemra®)
- etanercept (Enbrel®)
- adalimumab (Humira®)
- infliximab (Remicade®)
- rituximab (Rituxan®)
- abatacept (Orencia®)
- anakinra (Kineret®)
- certolizumab pegol (Cimzia®)
- golimumab (Simponi®)
- tofacitinib (Xeljanz®/Xeljanz XR®)
- sarilumab (Kevzara®)
- azathioprine or cyclosporine
- 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 with or without food.
For more information, call 1-800-545-5979 or go to www.olumiant.com.
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 06DEC2021