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 in patients with rheumatoid arthritis (RA). Results of the study showed that as of January 2019, there were 19 cases of pulmonary embolism (PE) and 45 deaths out of 3884 patient-years of follow-up in patients who received tofacitinib 10mg twice daily vs 3 cases of PE and 25 deaths out of 3982 patient-years in those who received tumor necrosis factor (TNF) blockers.  

Although not recommended for RA, the 10mg twice daily dose of tofacitinib is approved for use in the treatment of ulcerative colitis; while the increased risk of PE and death was seen in patients with RA, the FDA notes in their safety announcement that these risks may also apply to those with ulcerative colitis. As such, the FDA now states that the use of tofacitinib for ulcerative colitis should be reserved as second-line therapy for use in patients who have failed or cannot tolerate TNF blockers.

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For treatment of ulcerative colitis, healthcare professionals are urged to use the lowest effective dose for the shortest duration that will achieve and maintain therapeutic response. In addition, tofacitinib should be discontinued if a patient presents with symptoms of thrombosis; in those at increased risk of thrombosis, tofacitinib should be avoided.

According to the FDA, the safety study is ongoing and additional findings will be reported to the public once they are available. Clinicians can report adverse events associated with tofacitinib to the FDA’s MedWatch program

Tofacitinib, a Janus kinase (JAK) inhibitor, is marketed under the brand names Xeljanz and Xeljanz XR. Xeljanz and Xeljanz XR are both approved for the treatment of certain adults with moderate to severe rheumatoid arthritis and active psoriatic arthritis, while Xeljanz is also indicated for moderate to severe ulcerative colitis.

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