First Once-Daily JAK Inhibitor Approved for Rheumatoid Arthritis

The FDA today approved Pfizer's tofacitinib citrate (Xeljanz) extended-release tablets, the first and only once-daily oral Janus kinanse inhibitor for treating rheumatoid arthritis.

The 11-mg tablets are designed for patients who have not had an adequate response to or who are intolerant of methotrexate.

“The availability of Xeljanz XR provides physicians with a new treatment option for people with rheumatoid arthritis who may prefer an oral once-daily treatment,” said Roy Fleischmann, clinical professor in the Department of Internal Medicine at the University of Texas Southwestern Medical Center, in a press release.

Both Xeljanz and Xeljanz XR can be taken with or without methotrexate or other nonbiologic disease-modifying antirheumatic drugs.

It is currently unknown whether the products are safe for children or patients with hepatitis B or C. Patients with severe liver problems should not take Xeljanz or Xeljanz XR.

Patients should be informed that the products may lower the body’s ability to fight infections, and they may be at higher risk of developing shingles.

Health care providers should test patients for tuberculosis before starting the treatment.

Adverse effects may include upper respiratory tract infections, headache, diarrhea, nasal congestion, sore throat, and runny nose.