y the time the patient sees the inert tablet shell.
SPL UNCLASSIFIED SECTION
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
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LAB-0445-12.0
MEDICATION GUIDE
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: December 2017
Medication Guide
XELJANZ (ZEL' JANS')
XELJANZ XR (ZEL' JANS' EKS-AHR)
(tofacitinib)
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 and during treatment.
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 (herpes zoster).
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, 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, 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 stoma |
