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XELJANZ is a medication called a Janus kinase (JAK) inhibitor. It is used to treat adults with moderately to severely active rheumatoid arthritis (RA) in which methotrexate did not work well. Your healthcare provider can help determine if XELJANZ is right for you.

For more information, see Is XELJANZ for You?

XELJANZ is the first in a new class of treatments for moderate to severe RA called Janus kinase (JAK) inhibitors. JAK inhibitors work deep inside the cell to disrupt cellular activities that occur in signaling pathways, known as the JAK pathways.

In some patients, XELJANZ can begin to work in as early as 2 weeks to help relieve joint pain and swelling. And, in clinical trials, more than half of XELJANZ patients felt an improvement in RA symptoms at 3 months. Everybody is different though, so your results may differ.

Learn more about how XELJANZ performed in Clinical Trial Results.

XELJANZ has been shown to be effective in slowing the progression of joint damage. In a clinical trial at 6 months, XELJANZ reduced joint damage progression better than methotrexate.

In the ORAL Start Study, XELJANZ patients hadn't taken methotrexate prior to the study. However, XELJANZ is only approved for use in patients for whom methotrexate did not work well. At 6 months, XELJANZ patients got worse by 0.2 units of change on the modified Total Sharp Score (mTSS) scale, while patients taking methotrexate worsened by 0.8. mTSS measures joint damage progression in selected joints of the hands and feet. The higher the amount of change in the mTSS, the more joint damage has progressed.

In the ORAL Scan Study, patients who took XELJANZ and methotrexate had less progression of joint damage after 6 months (0.1) than those who took a placebo and methotrexate (0.5). However, the possibility was high enough that the difference between treatments may have been due to chance alone and not due to XELJANZ, so the results were not considered significant.

The active ingredient in XELJANZ is tofacitinib citrate.

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.

Your healthcare provider should do blood tests to check your cholesterol levels 4-8 weeks after you start XELJANZ, and as needed after that.

No. XELJANZ cannot be taken with a biologic treatment. Be sure to tell your healthcare provider about all the medicines you take.

For more information, see Rheumatoid Arthritis (RA) Treatment Options.

XELJANZ is taken by mouth. It can be taken with or without food.

For more information, see What is XELJANZ?

  • Take XELJANZ as prescribed by your healthcare provider.
  • Take XELJANZ twice a day with or without food.
  • If you take too much XELJANZ, call your healthcare provider or go to the nearest hospital emergency room right away.

You should also take into account the following safety advice:

  • Keep XELJANZ and all medicines out of the reach of children.
  • Do not use XELJANZ for a condition for which it was not prescribed.
  • Do not give XELJANZ to other people, even if they have the same symptoms you have. It may harm them.

For more information, see Safety & Side Effects.

Contact your healthcare provider if you miss a dose or forget to take XELJANZ for an extended period of time.

Keep in mind that everybody is different. If you are not getting the results you expected, talk with your healthcare provider. Together you can determine if changing your course of treatment might be an appropriate step.

To help you determine how XELJANZ is working, see Tracking Your Progress.

  • Create daily reminders—by using a pillbox or sticky notes—to help you stay on track. When you register for the XELJANZ+You Support Program, you’ll receive both as a free gift.
  • Set up alerts to remind you when it’s time to take XELJANZ.
  • Take XELJANZ with your morning and evening meals or before or after you brush your teeth.

About Safety

XELJANZ may cause serious side effects, including serious infections, cancer and immune system problems, tears (perforation) in the stomach or intestines, and changes in certain laboratory test results.

These are not all the possible side effects of XELJANZ. To read more, see Safety & Side Effects.

The common side effects of XELJANZ include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis).

These are not all the possible side effects of XELJANZ. To read more, see Safety & Side Effects.

Tell your healthcare provider about any side effects you are experiencing.

You may report side effects to the FDA at 1-800-FDA-1088.

You may also report side effects to Pfizer at 1-800-438-1985.

Before starting XELJANZ, be sure to talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known if XELJANZ will harm an unborn baby.

Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking XELJANZ, talk to your healthcare provider about how you can join this pregnancy registry or you may contact the registry at 1-877-311-8972 to enroll.

For more information, see Safety & Side Effects.

Before starting XELJANZ, you and your healthcare provider should decide if you will take XELJANZ or breastfeed. You should not do both.