Baricitinib is currently being studied for the treatment of coronavirus disease 2019 (COVID-19). The FDA has approved an Emergency Use Authorization (EUA) to allow distribution of baricitinib to treat certain adults and children 2 years of age and older who are hospitalized with a COVID-19 infection.
FDA Safety Alert [Posted 9/1/21]:
FDA is requiring new and updated warnings about an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with the medicines Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib), and Rinvoq (upadacitinib) used to treat certain serious inflammatory conditions including rheumatoid arthritis (RA) and ulcerative colitis.
We are also limiting the use of these medicines to certain patients who are not treated effectively or who experience severe side effects with another type of medicine used to treat serious inflammatory conditions called tumor necrosis factor (TNF) blockers.
If you are taking Xeljanz/Xeljanz XR, Olumiant, or Rinvoq, tell your health care professional if you are a current or past smoker, or have had a heart attack, other heart problems, stroke, or blood clots in the past as these may put you at higher risk for serious problems with the medicines. Before starting these medicines, also tell your health care professional about these risk factors.
Seek emergency help right away if you have any symptoms that may signal a heart attack, stroke, or blood clot, 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
- Drooping on one side of your mouth
- Swelling of a leg or arm
- Leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm
Also inform your health care professionals if you experience signs and symptoms such as:
- Swelling of lymph nodes in your neck, armpits or groin
- Constantly feeling tired
- Night sweats
- Persistent or worsening cough
- Difficulty breathing
- Hoarseness or wheezing
- Unexplained weight loss
Read the patient Medication Guide every time you receive a prescription for Xeljanz/Xeljanz XR, Olumiant, or Rinvoq. The Medication Guide will be updated with this new or other important information about your medicine. It explains the important things that you need to know. These include the side effects, what the medicine is used for, how to take and store it properly, and other things to watch out for when you are taking the medicine. Talk to your health care professional if you have any questions or concerns.
Taking baricitinib may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe fungal, bacterial, or viral infections that spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores), and chronic infections that do not go away. Tell your doctor if you are taking medications that decrease the activity of the immune system such as the following: abatacept (Orencia); adalimumab (Humira); azathioprine (Azasan, Imuran); certolizumab pegol (Cimzia); cyclosporine (Gengraf, Neoral, Sandimmune); etanercept (Enbrel); golimumab (Simponi); infliximab (Remicade); leflunomide (Arava); methotrexate (Otrexup; Rasuvo, Trexall); rituximab (Rituxan); sarilumab (Kevzara); steroids including dexamethasone, methylprednisolone (Medrol), prednisolone (Prelone), and prednisone (Rayos); tocilizumab (Actemra); and tofacitinib (Xeljanz).
Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: fever; sweating; chills; muscle aches; cough; shortness of breath; weight loss; warm, red, or painful skin; sores on the skin; frequent, painful, or burning feeling during urination; diarrhea, or excessive tiredness.
You may already be infected with tuberculosis (TB; a serious lung infection) but not have any symptoms of the disease. In this case, taking baricitinib may make your infection more serious and cause you to develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection before and during your treatment with baricitinib. If necessary, your doctor will give you medication to treat this infection before you start taking baricitinib. Tell your doctor if you have or have ever had TB, if you have lived in or visited a country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up bloody mucus, weight loss, loss of muscle tone, or fever.
Taking baricitinib may increase the risk that you will develop a lymphoma (cancer that begins in the cells that fight infection) or other types of cancers. Tell your doctor if you have or have ever had any type of cancer.
Baricitinib may increase the risk of serious and possibly life-threatening blood clot in the lungs or legs. If you experience any of the following side effects, call your doctor or get emergency medical treatment immediately: crushing chest pain or chest heaviness; shortness of breath; cough; pain, warmth, redness, swelling, or leg tenderness; or cold sensation in the arms, hands, or legs; or muscle pain.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to baricitinib.
Talk to your doctor about the risk(s) of taking baricitinib.
Why is this medication prescribed?
Baricitinib is used alone or with other medications to treat rheumatoid arthritis (condition in which the body attacks its own joints causing pain, swelling, and loss of function) in adults who have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s). Baricitinib is in a class of medications called Janus kinase (JAK) inhibitors. It works by decreasing the activity of the immune system.
How should this medicine be used?
Baricitinib comes as a tablet to take by mouth. It is usually taken with or without food once daily. Take baricitinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take baricitinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may need to temporarily or permanently stop treatment if you experience certain severe side effects. Be sure to tell your doctor how you are feeling during your treatment.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking baricitinib,
- tell your doctor and pharmacist if you are allergic to baricitinib, any other medications, or any of the ingredients in baricitinib tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section or the following: probenecid (Probalan, in Col-Probenecid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have stomach pain that has not been diagnosed or if you have or have ever had diverticulitis (swelling of the lining of the large intestine), anemia, herpes zoster (shingles; a rash that can occur in people who have had chickenpox in the past), or liver or kidney disease.
- tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking baricitinib, call your doctor.
- tell your doctor if you are breastfeeding. Do not breastfeed while taking baricitinib.
- tell your doctor if you have recently received or are scheduled to receive any vaccinations. Do not have any vaccinations during your treatment without talking to your doctor.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Baricitinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- abdominal pain
- bowel habit changes
Baricitinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What other information should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking baricitinib.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.