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Mylotarg is a prescription antibody-drug conjugate containing gemtuzumab ozogamicin. It is indicated for newly diagnosed CD33-positive acute myeloid leukemia in adults and children age 1 month and older. It also treats relapsed or refractory CD33-positive acute myeloid leukemia in adults and children age 2 and older. Each single-dose vial contains 4.5 mg for intravenous infusion after preparation.
read more about mylotarg ...Gemtuzumab is a monoclonal antibody that binds to the CD33 protein on susceptible leukemia cells. Following internalization, the linked cytotoxic compound, calicheamicin, is released inside the cell. Calicheamicin damages DNA, causing cell death. CD33 expression helps determine eligibility for treatment.
Mylotarg is used in adults and eligible pediatric patients with CD33-positive acute myeloid leukemia. Newly diagnosed patients can receive it in combination with other chemotherapy, while selected adults receive single-agent treatment. Relapsed or refractory disease has a separate single-agent regimen. Treatment requires specialist assessment of liver function, blood counts, disease status, and the risks of severe toxicity.
Dosing depends on age and treatment regimen. Adults with newly diagnosed disease receiving combination chemotherapy are given 3 mg per square meter intravenously on days 1, 4, and 7 of induction, with separate consolidation dosing. Newly diagnosed pediatric patients receive 3 mg per square meter or 0.1 mg per kg, depending on body surface area, on designated chemotherapy days. Relapsed or refractory disease in patients age 2 and older uses 3 mg per square meter on days 1, 4, and 7. Premedication is required before infusion.
Mylotarg carries a boxed warning for severe or fatal liver toxicity, including hepatic veno-occlusive disease, also called sinusoidal obstruction syndrome. Other serious concerns include infusion-related reactions, anaphylaxis, severe bleeding, low blood-cell counts, infections, tumor lysis syndrome, and fetal harm. Liver tests and blood counts are monitored closely, including when stem cell transplantation is planned.
Mylotarg treats CD33-positive acute myeloid leukemia under newly diagnosed and relapsed or refractory indications.
Yes. Newly diagnosed CD33-positive acute myeloid leukemia is an approved indication from age 1 month, while relapsed or refractory disease is approved from age 2.
Mylotarg is administered as an intravenous infusion under oncology supervision, with doses scheduled according to the treatment regimen.
Yes. Its boxed warning concerns severe or fatal liver injury, including veno-occlusive disease or sinusoidal obstruction syndrome.
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