Pfizer Announces FDA Approval of XELJANZ® XR (tofacitinib citrate) Extended-Release Tablets, the First and Only

62(4): 460- 464. 2010. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Common side effects include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, and nasal congestion, sore throat, and runny nose (nasopharyngitis). For more information, please visit us at www.pfizer.com.

Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. Healthcare providers may do blood tests before and during treatment with XELJANZ/XELJANZ XR. Mean LDL cholesterol increased by 15% in the XELJANZ 5 mg twice daily arm and 19% in the XELJANZ 10 mg twice daily arm. They should not do both. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. XELJANZ/XELJANZ XR may increase the risk of certain cancers by changing the way the immune system works.


The ORAL Scan study was conducted in patients with moderately to severely active RA who had an inadequate response to MTX. It is not known if XELJANZ/XELJANZ XR is safe and effective in people with hepatitis B or C. The risks and benefits of treatment should be considered prior to initiating XELJANZ in patients with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection. Avoid initiation of XELJANZ treatment in patients with a low lymphocyte count (i.e., less than 500 cells/mm3). Some people have died from these infections. • Some people taking XELJANZ get tears in their stomach or intestines.

There were 26 cases of active tuberculosis in the phase III and long-term extension studies, developing at a median time of 64 weeks after treatment initiation. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs). Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. Mucosal healing is defined by Mayo endoscopic subscore of 0 or 1. Thus, Hep B could become reactivated. It is specifically designed to inhibit the Janus kinase (JAK) pathways, which are signalling pathways inside the cell that play a role in the inflammation involved in RA.

The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. In general, for adults, take 1 tablet (5mg of Tofacitinib) twice a day. A supplemental new drug application for XELJANZ 10 mg and 5 mg tablets twice daily is currently under review with the FDA for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. In addition, a significantly greater number of patients receiving tofacitinib 10 mg BID achieved mucosal healing at Week 8 as compared to placebo, the key secondary endpoint in both studies. XELJANZ is specifically designed to inhibit the JAK pathways, which are signaling pathways inside the cell that play an important role in the inflammation involved in RA. Tofacitinib inhibits JAKs which in turn blocks the signaling of several cytokines and interleukins involved in lymphocyte function.

The recommended dose is 5 mg twice-daily (BID). This study evaluated the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active psoriatic arthritis (PsA) who had an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and who were tumor necrosis factor inhibitor (TNFi)-naïve. This study evaluated the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily (BID) in adult patients with active psoriatic arthritis (PsA) who had an inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and who were tumor necrosis factor inhibitor (TNFi)-naïve.