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What is XELJANZ?

XELJANZ (tofacitinib) is a prescription medicine called a Janus kinase (JAK) inhibitor used to treat:

  • Adults with moderately to severely active ulcerative colitis

It is not known if XELJANZ is safe and effective in children or in people with Hepatitis B or C.

XELJANZ is not recommended for people with severe liver problems.

XELJANZ may cause serious side effects, including:

Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections.

  • Your healthcare provider should test you for TB before starting and during XELJANZ treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster). People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of serious infections and shingles.

Before starting XELJANZ, tell your healthcare provider if you:

  • think you have an infection or have symptoms of an infection, such as fever, sweating, or chills; cough; blood in phlegm; warm, red, or painful skin or sores on your body; burning when you urinate or urinating more often than normal; muscle aches; shortness of breath; weight loss; diarrhea or stomach pain; or feeling very tired
  • are being treated for an infection
  • get a lot of infections or have infections that keep coming back
  • have diabetes, chronic lung disease, HIV, or a weak immune system. People with these conditions have a higher chance for infections
  • have TB, or have been in close contact with someone with TB
  • live or have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use XELJANZ. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common
  • have or have had Hepatitis B or C

After starting XELJANZ, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ can make you more likely to get infections or make worse any infection that you have.

Cancer and immune system problems. XELJANZ may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers, including skin cancers, can happen in patients taking XELJANZ. People taking the higher dose (10 mg twice daily) of XELJANZ have a higher risk of skin cancers. Tell your healthcare provider if you have ever had any type of cancer.

Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr Virus–associated post-transplant lymphoproliferative disorder).

Tears (perforation) in the stomach or intestines. Tell your healthcare provider if you have had diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines. Some people taking XELJANZ can get tears in their stomach or intestine. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Tell your healthcare provider right away if you have fever and stomach-area pain that does not go away and a change in your bowel habits.

Serious allergic reactions have happened in patients taking XELJANZ. If you have swelling of your lips, tongue, throat, or get hives, stop XELJANZ and call your healthcare provider right away.

Changes in certain lab test results. Your healthcare provider should do blood tests before you start receiving XELJANZ, and while you take XELJANZ, to check for the following side effects:

  • Changes in lymphocyte counts. Lymphocytes are white blood cells that help the body fight off infections.
  • Low neutrophil counts. Neutrophils are white blood cells that help the body fight off infections.
  • Low red blood cell count. This may mean that you have anemia, which may make you feel weak and tired.

Your healthcare provider should routinely check certain liver tests.

You should not receive XELJANZ if your lymphocyte count, neutrophil count, or red blood cell count is too low or your liver tests are too high. Your healthcare provider may stop your XELJANZ treatment for a period of time if needed because of changes in these blood test results.

You may also have changes in other laboratory tests, such as your blood cholesterol levels. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start XELJANZ, and as needed after that.

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