Important Safety Information

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

XELJANZ may cause serious side effects including:

Serious infections. XELJANZ can lower the ability of your immune system to fight infections. Some people 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 XELJANZ, 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.

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; muscle aches; cough; shortness of breath; blood in phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinating more often than normal; or 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 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 can happen in patients taking XELJANZ. 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. Some people taking XELJANZ 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.

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.

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

What should I tell my healthcare provider before taking XELJANZ?

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

• have an infection
• have liver problems
• have kidney problems
• have any stomach area (abdominal) pain or been diagnosed with diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines
• have had a reaction to tofacitinib or any of the ingredients in XELJANZ
• have recently received or are scheduled to receive a vaccine. People taking XELJANZ should not receive live vaccines but can receive non-live vaccines.
• have any other medical conditions
• plan to become pregnant or are 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.

• plan to breastfeed or are breastfeeding.

Tell your healthcare provider about all the medicines you take, especially 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. Taking XELJANZ with these medicines may increase your risk of infection.

• Tell your healthcare provider if you are taking 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.

What are other possible side effects of XELJANZ?

XELJANZ may cause serious side effects including 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. Tell your healthcare provider if you have the following symptoms of a possible hepatitis B or C infection: feeling very tired, skin or eyes look yellow, little or no appetite, vomiting, clay-colored bowel movements, fevers, chills, stomach discomfort, muscle aches, dark urine, or skin rash.

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

What is XELJANZ?

XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ 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 is safe and effective in people with Hepatitis B or C.
• XELJANZ is not for people with severe liver problems.
• It is not known if XELJANZ is safe and effective in children.