GEMTUZUMAB OZOGAMICIN
Manufacturer: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Score: 141.0
Mylotarg is a CD33-directed antibody-drug conjugate used for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older, and for the treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients 2 years and older. The drug has a boxed warning for hepatotoxicity, including severe or fatal hepatic veno-occlusive disease. Important safety information includes infusion-related reactions, hemorrhage, and increased risk of VOD. The recommended dose varies by patient population and treatment regimen, with initial dosing and titration details provided for different conditions. Special population considerations include use during pregnancy, pediatric use, and geriatric use.
Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease
Dose modifications may be necessary for patients with hematologic or non-hematologic toxicities
3 mg/m2 on Days 1, 4, and 7 in combination with daunorubicin and cytarabine
3 mg/m2 for patients with body surface area (BSA) greater than or equal to 0.6 m2, or 0.1 mg/kg for patients with BSA less than 0.6 m2
3 mg/m2 on Days 1, 4, and 7
3 mg/m2 on Days 1, 4, and 7 for patients 2 years and older