Treatment with MYLOTARG is commonly associated with a range of adverse reactions, including hematological and gastrointestinal toxicities, with hepatotoxicity being a particularly severe and potentially fatal risk.

Adverse Reaction Profile of MYLOTARG

The most common adverse reactions (occurring in >15% of patients) reported with MYLOTARG include hemorrhage, infection, fever, nausea, vomiting, constipation, headache, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), rash, mucositis, febrile neutropenia, and decreased appetite. A critical adverse reaction is hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS), which is highlighted in a boxed warning. Infusion-related reactions and hemorrhage (which can be severe or fatal) are also significant warnings. Other serious but less common adverse events are not specified in this summary section of the prescribing information.