The FDA has approved new warnings for the 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR), which is used in patients with ulcerative colitis, the agency announced on July 26.
A new boxed warning will alert clinicians about an increased risk of blood clots and of death with the 10-mg twice-daily dose of the drug. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe side effects with certain other medicines.
The changes follow the FDA's review of interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis that examined both this higher dose and a lower dose. The 10-mg twice-daily dose is not approved to treat rheumatoid arthritis or psoriatic arthritis. Clinicians should discontinue the drug and promptly evaluate patients if they have symptoms of thrombosis and, when treating ulcerative colitis, use tofacitinib at the lowest effective dose while limiting use of the 10-mg twice-daily dosage to the shortest duration needed.