Pfizer Updates XELJANZ Prescribing Information in U.S. with Safety Warnings
Pfizer has updated the U.S. prescribing information for XELJANZ® (tofacitinib) to include boxed warnings for mortality and thrombosis. Ulcerative colitis indication and dosing were also modified.
New York, USA – Pfizer Inc. announced an update to the U.S. prescribing information for XELJANZ® (tofacitinib), incorporating two new boxed warnings regarding mortality and thrombosis. The changes, mandated by the U.S. Food and Drug Administration (FDA), also include modifications to the indication and dosing for ulcerative colitis (UC).
The updates stem from FDA's review of data from the post-marketing requirement rheumatoid arthritis study, A3921133. The study revealed that patients aged 50 and older with rheumatoid arthritis and at least one cardiovascular risk factor treated with XELJANZ 10 mg twice daily experienced higher rates of all-cause mortality, including sudden cardiovascular death, compared to those on XELJANZ 5 mg twice daily or TNF blockers. Increased incidence of thrombosis, including pulmonary embolism, deep vein thrombosis, and arterial thrombosis, was also observed.
The boxed warnings advise avoiding XELJANZ/XELJANZ XR in patients at risk for thrombosis, to discontinue the drug and evaluate patients presenting with symptoms of thrombosis. For ulcerative colitis patients, the recommendation is to use XELJANZ at the lowest effective dose for the shortest duration needed to achieve and maintain therapeutic response.
For UC patients, the indication is now for moderately to severely active disease in those with inadequate response or intolerance to TNF blockers. The dosing section for UC specifies a maintenance dose of XELJANZ 5 mg twice daily, limiting the 10 mg twice daily dose beyond induction to patients experiencing loss of response.
Pfizer stated that XELJANZ remains an important treatment option for appropriate patients with rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The company expressed confidence in the drug's benefit/risk profile, citing over 50 clinical trials and more than 208,000 adult patients prescribed the medication worldwide.