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Safety Alerts and Recalls

Boxed Warning Added to Tofacitinib Prescribing Information

The Food and Drug Administration (FDA) has approved changes to the prescribing information for tofacitinib to include new warnings, including a Boxed Warning, regarding an increased risk of blood clots and death associated with the 10mg twice daily regimen.  The update comes after a review of data from an ongoing safety clinical trial of tofacitinib…
AIBD 2019

Tofacitinib vs Vedolizumab: Short-Term Efficacy Compared in Ulcerative Colitis

In patients with ulcerative colitis (UC), tofacitinib, a Janus kinase inhibitor, was associated with improved short-term efficacy, when compared with vedolizumab, an integrin receptor antagonist. Findings were presented at the Advances in Inflammatory Bowel Disease (AIBD) 2019 meeting in Orlando, Florida.
AIBD 2019

Impact of Tofacitinib on Extraintestinal Symptoms in UC Patients Examined

Treatment with tofacitinib appears to have little impact on extraintestinal manifestations (EIMs) in patients with moderate to severe ulcerative colitis (UC) and might even improve them, according to an analysis of the OCTAVE program. Findings were presented at the 2019 AIBD Annual Meeting in Orlando, Florida.
News

Xeljanz XR Approved for Ulcerative Colitis

The FDA has approved Xeljanz XR (tofacitinib extended-release; Pfizer) for the treatment of adult patients with moderately to severely active ulcerative colitis.