The Medicines and Healthcare Products Regulatory Agency (MHRA) London has announced that the product information for daratumumab will be updated to include the risk of reactivation of hepatitis B virus (HBV).
Daratumumab is indicated for the treatment of adult with newly diagnosed multiple myeloma and relapsed and refractory multiple myeloma.
A recent EU review of worldwide data has identified reports of HBV reactivation in patients treated with daratumumab. There were six cases observed in clinical trials in patients with multiple myeloma.
Previous autologous stem cell transplant and concurrent and/or prior lines of immunosuppressive therapy are risk factors of HBV reactivation.
WHO recommends that Health-care professionals should screen all patients for HBV before initiation of daratumumab and monitor patients. Also, they should stop treatment with daratumumab in patients with HBV reactivation and institute appropriate treatment in consultation with experts.
The Health Products Regulatory Authority (HPRA) Ireland has also announced that the product information for daratumumab (Darzalex®) has been updated to include a safety warning about the risk of HBV in patients treated with daratumumab.
