The administration of MYLOTARG necessitates vigilant monitoring for severe hepatotoxicity, including VOD/SOS, careful management of infusion-related reactions, awareness of potential hemorrhage, and consideration for embryo-fetal toxicity.

Critical Safety Considerations and Risk Mitigation for MYLOTARG

MYLOTARG carries a boxed warning for hepatotoxicity, including potentially fatal veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS); liver function must be frequently monitored. To mitigate infusion-related reactions (including anaphylaxis), premedication with a corticosteroid, acetaminophen, and diphenhydramine is required, and patients should be monitored during and after infusion. Hemorrhage, including severe and fatal events, can occur; platelet counts should be monitored frequently. MYLOTARG can cause embryo-fetal harm, and patients of reproductive potential must be advised of this risk and to use effective contraception. It is contraindicated in patients with a history of hypersensitivity to MYLOTARG.