New boxed warning cites increased risk of blood clots, death with higher dose

Generic Name: 
Trade Name: 
Xeljanz, Xeljanz XR

FDA has approved new warnings about an increased risk of blood clots and of death with the 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR) for treatment of ulcerative colitis. 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 adverse effects with certain other medicatuibs.

FDA approved these changes, including adding its most prominent boxed warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medication.

The 10-mg twice-daily dose of tofacitinib is not approved for RA or psoriatic arthritis (PsA). This dose is only approved for ulcerative colitis for initial treatment and for long-term use in limited situations. While the increased risks of blood clots and of death were seen in patients taking this dose for RA, these risks may also apply to those taking tofacitinib for ulcerative colitis.

Tofacitinib was first approved in 2012 to treat adult patients with RA who did not respond well to methotrexate. In 2017, FDA approved the drug to treat patients with PsA who did not respond well to methotrexate or other similar medications. In 2018, FDA approved tofacitinib to treat ulcerative colitis.

Health professionals should discontinue tofacitinib and promptly evaluate patients who have symptoms of thrombosis. Counsel patients about the risks, and advise them to seek medical attention immediately if they experience any unusual symptoms, including sudden shortness of breath, chest pain that worsens with breathing, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm.

Tofacitinib should be reserved for treatment of ulcerative colitis in patients who experienced treatment failure with tumor necrosis factor (TNF) blockers or could not tolerate them. Patients with a higher risk of thrombosis should not use the agent. For treatment of ulcerative colitis, tofacitinib should be used at the lowest effective dose, and the 10-mg twice daily dosage limited to the shortest duration needed.

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