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Direct Healthcare Professional Communication (DHPC) on Imbruvica® (ibrutinib): New risk minimisation measures, including dose modification recommendations, due to the increased risk for serious cardiac events

Active substance: ibrutinib

Janssen-Cilag International NV in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that Ibrutinib increases the risk of fatal and serious cardiac arrhythmias and cardiac failure. Prior to initiating ibrutinib, clinical evaluation of cardiac history and function should be performed.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 167KB, File does not meet accessibility standards