FDA Approves Extended-Release Xeljanz for Adults with Ulcerative Colitis

FDA Approves Extended-Release Xeljanz for Adults with Ulcerative Colitis

Xeljanz XR approval

The U.S. Food and Drug Administration (FDA) has approved Pfizer‘s extended-release tablets of Xeljanz XR (tofacitinib) to treat adults with moderately to severely active ulcerative colitis.

This approval of 11 mg and 22 mg doses offers these patients the option of taking the medication once, rather than twice, per day.

“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, PhD, chief development officer of inflammation and immunology at Pfizer Global Product Development, said in a press release.

“We are pleased to now offer patients with moderately to severely active ulcerative colitis and their healthcare providers a convenient once-daily dosing option with XELJANZ,” Corbo added.

Xeljanz was first approved by the FDA for the same indication in 2018 as a 10 mg, twice-daily oral therapy taken for at least eight weeks, after which patients could continue on either 5 mg or 10 mg twice a day.

With the newly approved extended-release version, patients can take 22 mg of Xeljanz XR once a day for eight weeks or up to a maximum of 16 weeks as induction therapy.

After the induction period, patients may take 11 mg of Xeljanz XR once a day as maintenance treatment.

For patients who have an inadequate response during the maintenance treatment period, physicians can prescribe either 10 mg Xeljanz twice a day or 22 mg Xeljanz XR once a day.

However, this higher dose in the maintenance period should be taken for the shortest time possible and only after carefully considering the risk and benefit to individual patients. Physicians should also use the lowest dose that can still effectively maintain a response.

Dose adjustments may be needed for patients who have moderate and severe kidney impairment or moderate liver impairment.

Xeljanz is an inhibitor of Janus kinases (JAK), which are enzymes that promote pro-inflammatory proteins involved in the development of autoimmune diseases such as ulcerative colitis. The therapy is indicated for patients who have had an inadequate response or are intolerant to TNF blockers, such as Humira (adalimumab).

It is not recommended that either Xeljanz or Xeljanz XR be used in combination with biological therapies for ulcerative colitis or with immunosuppressant medications, such as azathioprine and cyclosporine.

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