DARZALEX (daratumumab): New identified risk of Hepatitis B Virus reactivation


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DARZALEXTM (daratumumab) is indicated for the treatment of patients with multiple myeloma, and may be used in combination with other chemotherapy drugs, or as monotherapy in patients who had already been on three prior lines of therapy for multiple myeloma (for specific prescribing information, please refer to the DARZALEXTM product package insert).


A new important risk of Hepatitis B Virus (HBV) reactivation has been identified following the use of DARZALEXTM, including fatalities reported in clinical trials and post-marketing setting.


It is advised that:


NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter issued by Johnson & Johnson Sdn. Bhd. to highlight this safety issue. For further information, please contact your local sales person for a copy of the DHPC.