Xeljanz XR Receives New Indication for Ulcerative Colitis

December 12, 2019 – The U.S. FDA has approved a new indication for Xeljanz® XR (tofacitinib) 11mg and 22mg extended-release tablets, manufactured by Pfizer. Xeljanz XR is now approved to treat moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response or are intolerant to TNF blockers.

Ulcerative colitis is a chronic form of inflammatory bowel disease characterized by ulcers in the digestive tract. The condition generally develops over time and can become life-threatening if not well managed. Symptoms include diarrhea, abdominal and rectal pain, blood with bowel movements, fatigue, fever, and weight loss. Approximately one million people in the United States have UC.

In 2018, the FDA approved Xeljanz, a shorter-acting version of tofacitinib, to treat adults who have UC and have not had an adequate response to or been able to tolerate treatment with TNF blockers. The approval of Xeljanz XR now offers patients a once-daily treatment option, as opposed to the twice-daily dosing recommended with Xeljanz.

Both Xeljanz and Xeljanz XR require an induction phase. For Xeljanz XR, recommended dosing during this phase is 22mg taken once daily for eight weeks. If necessary, the induction phase can be extended to 16 weeks. Patients who do not have an adequate response by the end of 16 weeks of induction should discontinue Xeljanz XR.

Once patients transition to maintenance therapy, the recommended dose of Xeljanx XR is 11mg once daily. However, if there is a loss of response during maintenance treatment, the dose can be increased to 22mg once per day. Treatment at this dosage should be limited to the shortest duration possible. A black box warning cautions that Xeljanz and Xeljanz XR are associated with a risk of serious infection, malignancies, thrombosis (blood clots), and death.

Xeljanz first received FDA approval in 2012. Both Xeljanz and Xeljanz XR are also indicated to treat rheumatoid arthritis and psoriatic arthritis.