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Pfizer's Xeljanz (Tofacitinib) Approved to Treat Rheumatoid Arthritis

By November 8, 2012

Pfizer's Xeljanz (tofacitinib) prevents RA joint swelling in a novel way.Patients with moderate or severe rheumatoid arthritis who cannot tolerate or have not responded adequately to methotrexate (MTX) have a new option for symptom relief with Pfizer's Xeljanz (tofacitinib).

The U.S. Food and Drug Administration approved Xeljanz tablets on Nov. 2, after reviewing evidence showing that the medication effectively blocked the action of an enzyme that triggers swelling. Uniquely among other kinds of prescription RA treatments classified as disease-modifying antirheumatic drugs, Xeljanz targets substances called Janus kinases.

Patients should take one 5 mg Xeljanz tablet twice per day, and they can use the new drug in conjunction with MTX if side effects from the older medication have not been problems. Regardless, the potential for serious, even fatal, adverse events with Xeljanz needs to be a concern for all patients and their health care providers.

Prescribing information for Xeljanz includes a black box warning highlighting reports of opportunistic infections like tuberculosis, cancers like lymphoma and internal bleeding due to stomach or intestinal perforation. Though not common, these problems can occur because DMARDs fight an autoimmune disease, in which the body's own immune system attacks itself, by weakening the immune response.

A Medication Guide included as part of every Xeljanz label must be distributed to each patient every time he or she picks up a prescription. Pharmacists should seize these opportunities to counsel patients about spotting signs and symptoms of life-threatening complications, experiences with the drug more generally and overall health.

It is particularly important for pharmacists to know if any patients using Xeljanz have severe liver damage or are currently on other DMARDs other than MTX, and if women prescribed the new drug are pregnant or breastfeeding. Such patients should not take Xeljanz.

More common side effects reported by patients taking Xeljanz include colds, coughs, sore throats, nasal irritation, headaches and diarrhea.

Image courtesy of Pfizer

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