Ribomustin® (bendamustine): Increased Mortality Observed When Used in Non-approved Combination Treatments or Outside the Approved Indications; Monitor for Opportunistic Infections and Hepatitis B Reactivation

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Date: 25 September 2017

 

Description:

Increased mortality was observed in recent clinical studies when bendamustine was used in non-approved combination treatments (obinutuzumab and rituximab) or outside the approved indications (follicular lymphoma). Fatal toxicities were mainly due to opportunistic infections, but some fatal cardiac, neurological, and respiratory toxic effects were also reported.

Prescribers are reminded about important aspects of the safety profile arising from post-marketing data, which include serious and fatal opportunistic infections (particularly among patients with lymphocytopenia and low CD4-positive T-cell counts) and hepatitis B reactivation.

Please refer to the Direct Healthcare Professional Communication (DHPC) letter issued by Johnson & Johnson Sdn. Bhd. in agreement with NPRA for further information.

National Pharmaceutical Regulatory Agency (NPRA)
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