baricitinib

Pronunciation: BAR i SYE ti nib

Brand: Olumiant

What is the most important information I should know about baricitinib?

This medicine affects your immune system. You may get infections more easily, even serious or fatal infections.

Before or during treatment with baricitinib, tell your doctor if you have signs of infection such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

What is baricitinib?

Baricitinib is used to reduce pain, stiffness, and swelling in adults with rheumatoid arthritis after other treatments have failed. Baricitinib also helps slow the progression of bone and joint damage.

Baricitinib is also being studied for use in treating coronavirus. The US Food and Drug Administration (FDA) has authorized emergency use of baricitinib in combination with remdesivir to treat people who are hospitalized with COVID-19. This drug combination is for use in adults and children at least 2 years old who are using supplemental oxygen or a ventilator.

Baricitinib has not been approved to treat coronavirus or COVID-19, but this medicine may help certain people with COVID-19 who are treated with remdesivir.

Baricitinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking baricitinib?

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have ever had:

  • a chronic infection or weak immune system;
  • active tuberculosis;
  • liver disease (especially hepatitis B or C);
  • kidney disease (or if you are on dialysis);
  • lung disease;
  • diabetes;
  • HIV or AIDS;
  • a stomach or intestinal problem such as diverticulitis or an ulcer;
  • a perforation (a hole or tear) in your stomach or intestines;
  • a blood clot;
  • cancer;
  • low white or red blood cell counts; or
  • if you have recently received or are scheduled to receive any vaccine.

Using baricitinib may increase your risk of developing certain cancers, such as lymphoma or skin cancer. Ask your doctor about this risk.

Tell your doctor if you are pregnant or breastfeeding.

How should I take baricitinib?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using baricitinib.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take baricitinib with or without food.

Baricitinib affects your immune system. You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.

You must remain under the care of a doctor while you are using baricitinib for COVID-19. Use this medicine for the full prescribed length of time (usually for 14 days or until you leave the hospital, whichever comes first).

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking baricitinib?

Do not receive a "live" vaccine while using baricitinib. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What are the possible side effects of baricitinib?

Stop taking baricitinib and get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

  • fever, chills, sweating;
  • skin sores;
  • tiredness, muscle pain;
  • increased urination, pain or burning when you urinate;
  • stomach pain, diarrhea, weight loss; or
  • cough, shortness of breath, coughing up pink or red mucus.

Further doses may be delayed until your infection clears up.

Also call your doctor at once if you have:

  • symptoms of herpes virus --flu-like symptoms, cold sores around your mouth, numbness, tingling, itching, burning pain, painful skin rash or blisters;
  • signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • signs of a blood clot in your leg --swelling, pain, warmth, or redness in an arm or leg;
  • signs of perforation (a hole or tear) in your stomach or intestines --fever, ongoing stomach pain, change in bowel habits; or
  • signs of tuberculosis: fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common side effects may include:

  • herpes symptoms;
  • nausea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect baricitinib?

Tell your doctor about all your other medicines, especially:

  • methotrexate;
  • probenecid;
  • steroid medicine such as prednisone or dexamethasone;
  • NSAIDs (nonsteroidal anti-inflammatory drugs) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or
  • other drugs to treat rheumatoid arthritis --abatacept, adalimumab, anakinra, azathioprine, certolizumab, cyclosporine, etanercept, golimumab, infliximab, rituximab, sarilumab, tocilizumab, tofacitinib.

This list is not complete. Other drugs may affect baricitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about baricitinib.

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