The US Food and Drug Administration (FDA) issued a safety alert today concerning the dosing of the rheumatoid arthritis (RA) drug, Xeljanz and Xeljanz XR.
A safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib, the active ingredient in Xeljanz was used in patients with rheumatoid arthritis (RA).
FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis
The FDA states:
When FDA first approved tofacitinib, we required a clinical trial among patients with RA to evaluate the risk of heart-related events, cancer, and opportunistic infections with the medicine at two doses (10 mg twice daily and 5 mg twice daily) in combination with methotrexate in comparison to another drug called a tumor necrosis factor (TNF) inhibitor. RA patients in the trial were required to be at least 50 years old and have at least one cardiovascular risk factor. During the most recent analysis of the trial, an external data safety monitoring committee found an increased occurrence of blood clots in the lungs and death in patients treated with tofacitinib 10 mg twice daily compared to patients treated with tofacitinib 5 mg twice daily or a TNF inhibitor.
Health care professionals should follow the recommendations in the tofacitinib prescribing information for the specific condition they are treating.
Patients should not stop or change your dose of tofacitinib without first talking to your health care professional, as doing so may worsen your condition.