FDA is adding a new Boxed Warning about an increased risk of blood clots and death with the 10 mg twice-daily dose of tofacitinib (Xeljanz and Xeljanz XR, Pfizer) for patients with ulcerative colitis.
In addition, the 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. “We approved these changes, including adding our 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 medicine,” FDA said in safety notice.
The 10 mg twice-daily dose of tofacitinib is not approved for RA or psoriatic arthritis (PsA). That dose is approved for ulcerative colitis for initial treatment and for long-term use in limited situations, according to FDA. “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,” FDA sai
Earlier this year, FDA warned about an increased risk of death and blood clots in the lungs in patients with rheumatoid arthritis taking a 10 mg twice-daily dose tofacitinib.
Healthcare professionals should discontinue tofacitinib and promptly evaluate patients with symptoms of thrombosis, FDA said. “Counsel patients about the risks and advise them to seek medical attention immediately if they experience any unusual symptoms, including those of thrombosis…Reserve tofacitinib to treat ulcerative colitis for patients who have failed or do not tolerate tumor necrosis factor (TNF) blockers,” FDA said.
When treating ulcerative colitis, healthcare professionals should use tofacitinib at the lowest effective dose and limit the use of the 10 mg twice-daily dosage to the shortest duration needed.