Direct Healthcare Professional Communication (DHPC) on ▼Xeljanz (tofacitinib): increased risk of major adverse cardiovascular events and malignancies with use of tofacitinib relative to TNF-alpha inhibitors
2021.07.06
Active substance: tofacitinib
Pfizer Europe MA EEIG in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that in the completed clinical trial (A3921133) in patients with rheumatoid arthritis (RA) who were 50 years of age or older with at least one additional cardiovascular risk factor, an increased incidence of myocardial infarction was observed with tofacitinib compared to TNF-alpha inhibitors as well as an increased incidence of malignancies excluding NMSC. Prescribers should discuss with the patients the risks associated with the use of ▼Xeljanz, including myocardial infarction, lung cancer and lymphoma.
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