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Direct Healthcare Professional Communication (DHPC) on Venclyxto® (venetoclax) film coated tablets: updated recommendations on tumour lysis syndrome (TLS) in CLL patients

Active substance: venetoclax

AbbVie in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you of fatal cases of TLS, which have been observed even in patients receiving the lowest venetoclax dose used in dose-titration schedule. Strict adherence to dose titration and TLS risk minimisation measures as outlined in the SmPC is required for all patients. A patient card will be provided to prescribing haematologists to be given to each patient.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 110KB, File is accessible