XELJANZ- tofacitinib citrate tablet, film coated 
Pfizer Laboratories Div Pfizer Inc

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MEDICATION GUIDE
XELJANZ (ZEL' JANS')
(tofacitinib)

Read this Medication Guide before you start taking XELJANZ and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

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

XELJANZ may cause serious side effects including:

1. Serious infections.

XELJANZ is a medicine that affects your immune system. 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.

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:

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.

2. Cancer and immune system problems.

XELJANZ 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 and while you take XELJANZ to check for the following side effects:

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.

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

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

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.

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:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. XELJANZ 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?

What are possible side effects of XELJANZ?

XELJANZ may cause serious side effects, including:

Common side effects of XELJANZ 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. 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?

Store XELJANZ at 68°F to 77°F (room temperature).

Safely throw away medicine that is out of date or no longer needed.

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

General information about the safe and effective use of XELJANZ.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XELJANZ for a condition for which it was not prescribed. Do not give XELJANZ 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. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about XELJANZ 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.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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LAB-0535-2.0
March 2014

Revised: 04/2014
 
Pfizer Laboratories Div Pfizer Inc