FDA approves Xeljanz extended release tablets for ulcerative colitis
The FDA on Thursday approved Xeljanz extended release 11 mg and 22 mg tablets for the once daily treatment of adults with moderately to severely active ulcerative colitis, following an inadequate response or intolerance to previous TNF blocker therapy, according to a press release from the manufacturer.
“Ulcerative colitis is a chronic inflammatory disease of the colon that can significantly affect a patient’s quality of life and be emotionally burdensome due to symptoms, flares and complications,” Michael Corbo, chief development officer of Inflammation & Immunology at Pfizer Global Product Development, said in the release. “We are pleased to now offer patients with moderately to severely active ulcerative colitis and their health care providers a convenient once daily dosing option with Xeljanz.”
The manufacturer does not recommend the use of Xeljanz/Xeljanz XR (tofacitinib, Pfizer) in combination with other biologic therapies for UC or with other immunosuppressants such as azathioprine and cyclosporine.
From the first 8 to 16 weeks of induction therapy, tofacitinib 10 mg twice daily or tofacitinib extended release 22 mg once daily may be prescribed.
Following induction therapy, tofacitinib 5 mg twice daily or tofacitinib extended release 11 mg once daily may be prescribed as a maintenance therapy. Additionally, tofacitinib 10 mg twice daily or tofacitinib extended release 22 mg once daily may be considered for treatment but should be limited to the shortest duration with careful consideration of benefits and risks to each patient, according to the release.