The Food and Drug Administration (FDA) has approved Xeljanz XR (tofacitinib extended-release; Pfizer) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or who are intolerant to tumor necrosis factor blockers. 

The approval of Xeljanz XR, which is available in 11mg and 22mg extended-release tablets, was based on data obtained from clinical trials evaluating Xeljanz (tofacitinib) in adult patients with moderately to severely active UC. The extended-release formulation now allows for once-daily dosing for induction and maintenance therapy. 

If switching from Xeljanz to Xeljanz XR, patients treated with Xeljanz 5mg twice daily may be switched to Xeljanz XR 11mg once daily the day following the last dose of Xeljanz 5mg; those treated with Xeljanz 10mg twice daily may be switched to Xeljanz XR 22mg once daily following the last dose of Xeljanz 10mg; treatment should be initiated at the lowest effective dose and for the shortest duration needed to achieve and maintain therapeutic response.

The use of Xeljanz or Xeljanz XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended; there is a risk of added immunosuppression if taken together with immunosuppressive therapies. 


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Recently, the FDA added a boxed warning to the labeling for Xeljanz/Xeljanz XR regarding an increased risk of blood clots and death associated with the 10mg twice daily regimen. While the increased risk of pulmonary embolism and death was seen in patients with rheumatoid arthritis, the FDA noted that these risks could also apply to those with UC. As such, tofacitinib for UC is indicated as a second-line therapy.

In addition to the UC indication, Xeljanz XR is also approved for the treatment of certain adults with moderate to severe rheumatoid arthritis and active psoriatic arthritis.

For more information visit pfizer.com.