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FDA Approves Tofacitinib for Rheumatoid Arthritis

Kate Traynor

BETHESDA, MD 07 Nov 2012— FDA External Link on November 6 announced the approval of tofacitinib oral tablets as a second-line treatment for moderate to severe rheumatoid arthritis in adults.

According to Pfizer, tofacitinib is the first FDA-approved inhibitor of Janus kinase (JAK), a tyrosine-specific protein kinase that contributes to inflammation in patients with rheumatoid arthritis.

Pfizer will market tofacitinib as Xeljanz. The company expects the product to be available from pharmacies within the next three weeks.

Tofacitinib can be taken as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs) but should not be used in combination with biologic DMARDs or potent immunosuppressive drugs.

The 33-page FDA-approved labelingExternal Link for tofacitinib includes a boxed warning about the risk for serious infections and lymphomas and other cancers in patients treated with tofacitinib. These risks are also the focus of a medication guide that is included in the labeling.

According to the boxed warning, patients should be tested for latent tuberculosis (TB) before starting tofacitinib therapy. Patients who test positive for latent TB should be treated for the infection before initiating therapy with tofacitinib.

All patients, including those who initially tested negative for latent TB, should be monitored for active TB during treatment with tofacitinib.

Serious infections other than TB that have been reported during treatment with tofacitinib include pneumonia, cellulitis, herpes zoster, and urinary tract infections. Esophageal candidiasis, pneumocystosis, cytomegalovirus infection, and other opportunistic infections have also been reported.

The most common adverse events reported in clinical trials of tofacitinib included upper respiratory tract infections, headache, diarrhea, and nasopharyngeal inflammation.

The recommended dosage of tofacitinib is 5 mg taken twice daily with or without food. Therapy interruptions may be necessary in response to hematologic abnormalities.

The labeling recommends a dosage of 5 mg once daily in patients with moderate liver impairment or moderate or severe kidney impairment. This dosage is also recommended for patients using potent inhibitors of cytochrome P-450 (CYP) isoenzyme 3A4 or taking one or more medications that moderately inhibit CYP3A4 and strongly inhibit CYP2C19.

Other situations that may require dosage modifications or interruptions are described in the labeling for tofacitinib.

Tofacitinib will be available as 5-mg tablets packaged in bottles of 60 or 180 each. The bottles should be stored at controlled room temperature, and the tablets should not be repackaged for use.

 

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