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Health Canada Health products

DARZALEX (daratumumab) and Hepatitis B Virus Reactivation

Issued March 25, 2019
Issue
Cases of HBV reactivation, some with a fatal outcome, have been reported in patients treated with DARZALEX. As of December 14, 2018, there were 15 cases of HBV reactivation in patients treated with DARZALEX. No Canadian cases of HBV reactivation related to DARZALEX treatment have been reported.
Hazard description
Product safety