What is XELJANZ/XELJANZ XR?

The Difference Between XELJANZ & XELJANZ XR

The difference is how many times a day you take it—XELJANZ XR is the once-daily formulation of XELJANZ. If you're currently taking XELJANZ but are interested in a once-daily treatment, talk with your doctor about XELJANZ XR. Learn more about the two with the chart below.

XELJANZ XELJANZ XR
HOW IT'S TAKEN
Two times a day without food Once a day with or without food*
DOSAGE
5 mg tablet 11 mg extended release tablets
HOW IT'S DELIVERED
Immediate-release tablet that releases medication into the bloodstream over the course of several hours Extended-release tablet that releases medication into the bloodstream over the course of a day
CAN BE TAKEN WITHOUT METHOTREXATE
Yes Yes

*XELJANZ XR tablets should be swallowed whole and intact. Do not crush, split, or chew.

About XELJANZ & XELJANZ XR

When it comes to the treatment of your moderate to severe rheumatoid arthritis, there are a number of options that don’t involve needles, like XELJANZ XR, an Unjection. Not the only pill for RA, XELJANZ XR is a once-daily pill for adults with moderate to severe RA for whom methotrexate did not work well.

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

For more information, see Is XELJANZ For You?

XELJANZ/XELJANZ XR 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.

Learn more about the different treatment options and where XELJANZ fits into the mix.

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.

Learn how the progression of RA causes joint damage.

The active ingredient in XELJANZ/XELJANZ XR is tofacitinib.

Your healthcare provider should do blood tests before you start receiving XELJANZ/XELJANZ XR, and while you take XELJANZ/XELJANZ XR, 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/XELJANZ XR 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/XELJANZ XR 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/XELJANZ XR, and as needed after that.

XELJANZ/XELJANZ XR can reduce RA pain, and help stop further joint damage, even without methotrexate.

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

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

XELJANZ/XELJANZ XR is taken by mouth. XELJANZ is taken twice daily while XELJANZ XR is taken once daily. XELJANZ/XELJANZ XR can be taken with or without food.

For more information, see What Is XELJANZ?

When you take XELJANZ XR, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.

XELJANZ/XELJANZ XR may cause serious side effects, including:

Serious infections. XELJANZ/XELJANZ XR can lower the ability of your immune system to fight infections. Some people can have serious infections while taking XELJANZ/XELJANZ XR, 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/XELJANZ XR treatment, and monitor you closely for signs and symptoms of TB infection during treatment.

You should not start taking XELJANZ/XELJANZ XR 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/XELJANZ XR, 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/XELJANZ XR. 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/XELJANZ XR, call your healthcare provider right away if you have any symptoms of an infection. XELJANZ/XELJANZ XR can make you more likely to get infections or make worse any infection that you have.

For more information, see Safety & Side Effects.

Contact your healthcare provider if you miss a dose or forget to take XELJANZ/XELJANZ XR 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 RA Symptom & Activity Tracker.

  • Create daily reminders—by using your mobile phone or sticky notes—to help you stay on track. When you register for the XELJANZ+You Support Program, you’ll receive sticky notes and other helpful items like an RA-friendly water bottle as a free gift.
  • Set up alerts to remind you when it’s time to take XELJANZ/XELJANZ XR.
  • Take XELJANZ with your morning and evening meals or before or after you brush your teeth. Take once-daily XELJANZ XR only in the morning or only in the evening.

About Safety

XELJANZ/XELJANZ XR 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/XELJANZ XR. To read more, see Safety & Side Effects.

Patients should always ask their doctors for medical advice about adverse events.

Common side effects of XELJANZ/XELJANZ XR in rheumatoid arthritis and psoriatic arthritis patients include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, nasal congestion, sore throat, and runny nose (nasopharyngitis), and high blood pressure (hypertension).

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

Patients should always ask their doctors for medical advice about side effects or adverse events. You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.

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

Pregnancy Registry: Pfizer has a registry for pregnant women who take XELJANZ/XELJANZ XR. 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/XELJANZ XR, 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/XELJANZ XR, you and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR or breastfeed. You should not do both. After you stop your treatment with XELJANZ/XELJANZ XR do not start breastfeeding again until: 18 hours after your last dose of XELJANZ or 36 hours after your last dose of XELJANZ XR.

LEARN ABOUT REAL
PATIENT EXPERIENCES
WITH XELJANZ.