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Xeljanz

"Nov. 6, 2012 -- The FDA has approved Pfizer's Xeljanz (tofacitinib), a first-of-its-kind treatment for rheumatoid arthritis.

Xeljanz is approved for use by patients not helped by methotrexate, the usual first treatment for RA. It's a "...

Xeljanz

Xeljanz Patient Information Including Side Effects

Brand Names: Xeljanz

Generic Name: tofacitinib (Pronunciation: TOE fa SYE ti nib)

What is tofacitinib (Xeljanz)?

Tofacitinib works by blocking certain enzymes in the body that affect immune system function.

Tofacitinib is used to treat moderate to severe rheumatoid arthritis in adults who have tried methotrexate without successful treatment of symptoms. Tofacitinib is sometimes given in combination with methotrexate or other arthritis medications.

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

What are the possible side effects of tofacitinib (Xeljanz)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with tofacitinib. Stop using this medicine and call your doctor right away if you have signs of infection such as:

  • fever, chills, tired feeling, night sweats;
  • stomach pain, loss of appetite, diarrhea, weight loss, or a change in your bowel habits;
  • pain or burning when you urinate;
  • body aches, sore throat, flu symptoms, sores in your mouth and throat;
  • stabbing chest pain, wheezing, feeling short of breath, cough with mucus or blood; or
  • skin redness and swelling.

Tofacitinib may also cause severe liver symptoms. Call your doctor at once if you have any of these liver symptoms:

  • low fever, itching;
  • upper stomach pain, loss of appetite;
  • dark urine, clay-colored stools; or
  • jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache; or
  • mild cold symptoms such as runny or stuffy nose.

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.

Read the Xeljanz (tofacitinib tablets) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about tofacitinib (Xeljanz)?

Tofacitinib is used to treat moderate to severe rheumatoid arthritis in adults who have tried methotrexate without successful treatment of symptoms.

You should not use tofacitinib if you have severe liver disease.

Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, sores or white patches in your mouth or throat, night sweats, stomach pain, diarrhea, weight loss, skin redness and swelling, or cough and chest pain.

If you have hepatitis B or C you may develop liver symptoms while taking this medication. Your doctor may want to check your liver function before and during your treatment with tofacitinib.

Do not receive a "live" vaccine while using tofacitinib, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

Side Effects Centers
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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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