(BPT) – Rheumatoid Arthritis (RA) can be painful and disabling, placing a considerable physical and emotional burden on patients. It is a serious autoimmune disease that affects approximately 1.6 million Americans, and for some patients with RA there is an additional treatment option available in the U.S.

In November 2012, the U.S. Food and Drug Administration (FDA) approved XELJANZ® (tofacitinib citrate) 5 mg tablets for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to methotrexate. XELJANZ may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs). XELJANZ should not be used in combination with biologic DMARDs or with potent immunosuppressives, such as azathioprine and cyclosporine.

Although multiple treatments are available for RA, there is a need for additional options. Up to one-third of patients do not adequately respond to treatment, and about half stop responding to any particular DMARD within five years.

“XELJANZ, the first oral DMARD approved for RA in more than 10 years, offers an additional treatment option for people with RA and for the doctors who treat it,” said Dr. Mark Genovese, MD, Professor of Medicine, Stanford University Immunology & Rheumatology Division. “In some clinical trials for RA, XELJANZ was effective in relieving signs and symptoms and in improving physical function. I am glad to have an additional option to offer my patients with moderately to severely active RA.”

XELJANZ is the first approved RA medicine in a new class of drugs known as Janus kinase (JAK) inhibitors. JAKs are proteins inside cells that influence the immune system by sending signals through a pathway. XELJANZ inhibits the JAK pathways. It has a novel mechanism of action and is in the form of a pill.

The approval of XELJANZ is based on clinical trial data from approximately 5,000 patients with 7,000 patient-years of exposure.

Safety findings observed in the overall XELJANZ RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; decreased hemoglobin; liver enzyme elevations; and lipid elevations.

The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, diarrhea and nasopharyngitis.

With the approval of XELJANZ, Pfizer has also developed XELSOURCE, a patient assistance resource, which provides information about access and coverage for XELJANZ. To learn more about XELSOURCE, visit XELJANZ.com or call 1-855-4-XELJANZ (1-855-493-5526).

For full prescribing information, including boxed warning and Medication Guide, please visit www.XELJANZ.com.

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.

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 tiredare being treated for an infectionget a lot of infections or have infections that keep coming backhave 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 TBlive 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.

For full prescribing information, including boxed warning and Medication Guide, please visit www.XELJANZ.com.