XELJANZ- tofacitinib tablet, film coated 
XELJANZ  XR- tofacitinib tablet, film coated, extended release 
Pfizer Laboratories Div Pfizer Inc

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Medication Guide
XELJANZ (ZEL' JANS')
XELJANZ XR (ZEL' JANS' EKS-AHR)
(tofacitinib)
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: February 2016

What is the most important information I should know about XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR may cause serious side effects including:

1. Serious infections.

XELJANZ/XELJANZ XR is a medicine that affects your immune system. 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 XELJANZ/XELJANZ XR.
  • Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with XELJANZ/XELJANZ XR.

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.

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
  • feeling very tired
  • are being treated for an infection.
  • get a lot of infections or have infections that keep coming back.
  • have diabetes, 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, 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.

2. Cancer and immune system problems. XELJANZ/XELJANZ XR 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/XELJANZ XR. 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).

3. 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/XELJANZ XR can get tears in their stomach or intestines. 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.

4. Changes in certain laboratory test results. 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.

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 receiving XELJANZ/XELJANZ XR, and as needed after that. Normal cholesterol levels are important to good heart health.

See "What are the possible side effects of XELJANZ/XELJANZ XR?" for more information about side effects.

What is XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well.

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

XELJANZ/XELJANZ XR is not for people with severe liver problems.

It is not known if XELJANZ/XELJANZ XR is safe and effective in children.

What should I tell my healthcare provider before taking XELJANZ/XELJANZ XR?

XELJANZ/XELJANZ XR may not be right for you. Before taking XELJANZ/XELJANZ XR, tell your healthcare provider if you:

  • have an infection. See "What is the most important information I should know about XELJANZ/XELJANZ XR?"
  • have liver problems
  • have kidney problems
  • have any stomach area (abdominal) pain or been diagnosed with diverticulitis or ulcers in your stomach or intestines
  • have had a reaction to tofacitinib or any of the ingredients in XELJANZ/XELJANZ XR
  • have recently received or are scheduled to receive a vaccine. People who take XELJANZ/XELJANZ XR should not receive live vaccines. People taking XELJANZ/XELJANZ XR can receive non-live vaccines.
  • have any other medical conditions.
  • plan to become pregnant or are 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.
  • plan to breastfeed or are breastfeeding. You and your healthcare provider should decide if you will take XELJANZ/XELJANZ XR or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. XELJANZ/XELJANZ XR and other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

  • any other medicines to treat your rheumatoid arthritis. You should not take tocilizumab (Actemra®), etanercept (Enbrel®), adalimumab (Humira®), infliximab (Remicade®), rituximab (Rituxan®), abatacept (Orencia®), anakinra (Kineret®), certolizumab (Cimzia®), golimumab (Simponi®), azathioprine, cyclosporine, or other immunosuppressive drugs while you are taking XELJANZ or XELJANZ XR. Taking XELJANZ or XELJANZ XR with these medicines may increase your risk of infection.
  • medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take XELJANZ/XELJANZ XR?

  • Take XELJANZ/XELJANZ XR exactly as your healthcare provider tells you to take it.
  • Take XELJANZ 2 times a day with or without food.
  • Take XELJANZ XR 1 time a day with or without food.
  • Swallow XELJANZ XR tablets whole and intact. Do not crush, split, or chew.
  • 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.
  • If you take too much XELJANZ/XELJANZ XR, call your healthcare provider or go to the nearest hospital emergency room right away.

What are possible side effects of XELJANZ/XELJANZ XR?

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

  • See "What is the most important information I should know about XELJANZ/XELJANZ XR?"
  • Hepatitis B or C activation infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while you use XELJANZ/XELJANZ XR. Your healthcare provider may do blood tests before you start treatment with XELJANZ and while you are using XELJANZ/XELJANZ XR. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B or C infection:
  • feel very tired
  • little or no appetite
  • clay-colored bowel movements
  • chills
  • muscle aches
  • skin rash
  • skin or eyes look yellow
  • vomiting
  • fevers
  • stomach discomfort
  • dark urine

Common side effects of XELJANZ/XELJANZ XR include:

  • upper respiratory tract infections (common cold, sinus infections)
  • headache
  • diarrhea
  • nasal congestion, sore throat, and runny nose (nasopharyngitis)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of XELJANZ/XELJANZ XR. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

How should I store XELJANZ/XELJANZ XR?

  • Store XELJANZ/XELJANZ XR at room temperature between 68°F to 77°F (20°C to 25°C).
  • Safely throw away medicine that is out of date or no longer needed.

Keep XELJANZ/XELJANZ XR and all medicines out of the reach of children.

General information about the safe and effective use of XELJANZ/XELJANZ XR.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XELJANZ/XELJANZ XR for a condition for which it was not prescribed. Do not give XELJANZ/XELJANZ XR to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about XELJANZ/XELJANZ XR. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about XELJANZ/XELJANZ XR that is written for health professionals.

What are the ingredients in XELJANZ?

Active ingredient: tofacitinib citrate

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6cP, titanium dioxide, macrogol/PEG3350, and triacetin.

What are the ingredients in XELJANZ XR?

Active ingredient: tofacitinib citrate

Inactive ingredients: sorbitol, hydroxyethyl cellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropyl cellulose, HPMC 2910/Hypromellose, titanium dioxide, triacetin, and red iron oxide. Printing ink contains shellac glaze, ammonium hydroxide, propylene glycol, and ferrosoferric oxide/black iron.

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LAB-0535-4.0

Revised: 3/2016
Pfizer Laboratories Div Pfizer Inc