FDA Updates Drug Safety Communication for Tofacitinib (Xeljanz, Xeljanz XR)

PUBLISHED: Jul 29, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (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), which is used in patients with 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 side effects with certain other medicines. FDA approved these changes, including adding the agency’s 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.

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.

Patients should be instructed to tell their health care professionals if they have a history of blood clots or heart problems and talk to them about any questions or concerns. Stop taking tofacitinib and seek emergency medical attention right away if experiencing any unusual symptoms, including those that may signal a blood clot.

Health care professionals should:

  • Discontinue tofacitinib and promptly evaluate patients with symptoms of thrombosis.
  • 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.
  • Avoid tofacitinib in patients who may have a higher risk of thrombosis.
  • When treating ulcerative colitis, use tofacitinib at the lowest effective dose and limit the use of the 10 mg twice daily dosage to the shortest duration needed

See the drug safety communication for additional information.

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