XELJANZ- tofacitinib citrate tablet, film coated
XELJANZ XR- tofacitinib citrate tablet, film coated
Pfizer Laboratories Div Pfizer Inc
XELJANZ (ZEL' JANS')
XELJANZ XR (ZEL' JANS' EKS-AHR)
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: February 2016|
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.
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:
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.
3. Tears (perforation) in the stomach or intestines.
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:
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:
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:
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?
XELJANZ/XELJANZ XR may cause serious side effects, including:
Common side effects of XELJANZ/XELJANZ XR include:
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?
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.