Drugs in the Pipeline, News
Tofacitinib Ext-Rel Monotherapy Effective for Moderate to Severe RA After Methotrexate Withdrawal
The ORAL Shift study enrolled 694 RA patients who were inadequate responders to methotrexate alone.
Your search for tofacitinib returned 5 results
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…
Safety Alerts and Recalls
Increased Risk of Pulmonary Embolism, Death in RA Patients Reported in Tofacitinib Postmarketing Study
According to data from on an ongoing postmarketing safety trial conducted by Pfizer, tofacitinib dosed at 10mg twice daily was associated with an increased risk of pulmonary embolism and overall mortality in patients with rheumatoid arthritis (RA).
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.
Drugs in the Pipeline
Upadacitinib Gets FDA’s Priority Review for Treatment of Moderate to Severe RA
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for upadacitinib (AbbVie), an investigational oral JAK1-selective inhibitor, for the treatment of moderate to severe rheumatoid arthritis (RA).
