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

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Description

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:

  • All patients should undergo HBV screening before treatment initiation with DARZALEXTM.
  • For patients with positive HBV serology, monitor clinical and laboratory signs of HBV reactivation during treatment with DARZALEXTM. Continue monitoring for at least six (6) months after treatment completion. Patients should be managed according to clinical guidelines.
  • In patients who developed HBV reactivation during DARZALEXTM treatment, it is recommended that treatment with DARZALEXTM, any concomitant steroids and chemotherapy be suspended, followed by instituting appropriate treatment. In patients whose HBV reactivation are adequately controlled, treatment of DARZALEXTM may be resumed following a thorough discussion with physicians experienced in HBV management.

 

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.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Friday 18 October 2019, 10:30:39.
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