Tofacitinib 5mg, 10mg; tabs.
Tofacitinib 11mg, 22mg; ext-rel tabs.
Tofacitinib 1mg/mL; grape flavor; contains sucralose, xylitol.
The approval was based on data from a phase 3 study which evaluated tofacitinib in adults with active AS who had an inadequate response to at least 2 NSAIDs.
Results of the ORAL Surveillance study showed a higher risk for major adverse CV events and venous thromboembolism with tofacitinib vs TNFis.
Researchers compared the effectiveness of tofacitinib and vedolizumab among patients with UC who had experienced anti-TNF failure.
Safety Alerts and Recalls
The revisions are based on a completed review of a large randomized safety clinical trial, which included 4362 patients with rheumatoid arthritis.