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# Mylotarg (gemtuzumab ozogamicin) ## Overview Mylotarg is an antibody-drug conjugate targeting CD33, a protein found on the surface of leukemic cells in acute myeloid leukemia (AML). It delivers a cytotoxic agent, calicheamicin, directly to CD33-positive cells. ## Primary Indications * Treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are able to undergo induction chemotherapy. * Treatment of relapsed or refractory AML in adults. ## Adult Dosing **Newly Diagnosed AML (in combination with chemotherapy):** * First cycle: 3 mg/m² on days 1, 4, and 7. * Second cycle (if needed): 3 mg/m² on days 1 and 7. * *Note: Dosing and schedule may vary based on the specific chemotherapy regimen and local protocols.* **Relapsed or Refractory AML:** * 3 mg/m² on day 1. * If patient achieves at least partial remission, a second dose of 3 mg/m² may be given on day 15. * A third dose of 3 mg/m² may be given on day 29 if the patient maintains remission. * Maximum cumulative dose is 13.3 mg/m² over the course of therapy. ## Pediatric Dosing Mylotarg is not approved for use in pediatric patients. ## Dose Adjustments * **Hepatic Impairment:** Use with caution. Monitor liver function tests closely. Dose reduction may be necessary. * **Veno-occlusive Disease (VOD) / Sinusoidal Obstruction Syndrome (SOS):** Discontinue Mylotarg if severe VOD/SOS occurs. ## Contraindications * Hypersensitivity to gemtuzumab ozogamicin or any component of the formulation. ## Adverse Effects * **Hematologic:** Myelosuppression (neutropenia, thrombocytopenia, anemia, leukopenia). * **Hepatobiliary:** Hyperbilirubinemia, elevated AST/ALT, veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) – potentially fatal, especially with prior stem cell transplant or hepatic impairment. * **Gastrointestinal:** Nausea, vomiting, diarrhea, stomatitis. * **Infections:** Sepsis, febrile neutropenia. * **Other:** Fatigue, fever, headache, rash. ## Key Drug Interactions * **Hepatotoxic Agents:** Concomitant use with other medications known to cause liver injury may increase the risk of hepatotoxicity. * **Myelosuppressive Agents:** Concurrent use with chemotherapy increases the risk of severe myelosuppression. ## Monitoring * Complete blood counts (CBC) with differential and platelet count prior to each dose and as clinically indicated. * Liver function tests (bilirubin, AST, ALT) prior to each dose and as clinically indicated. * Monitor for signs and symptoms of VOD/SOS (e.g., hyperbilirubinemia, jaundice, hepatomegaly, ascites, weight gain). ## Clinical Pearls * Mylotarg carries a boxed warning for hepatotoxicity, including VOD/SOS. This risk is increased in patients who have received prior stem cell transplantation or have pre-existing hepatic impairment. * Due to the risk of severe myelosuppression, careful monitoring of blood counts is essential. * The decision to administer subsequent doses in relapsed/refractory AML should be based on patient response and tolerability. --- *This information is intended for healthcare professionals and does not replace the need to consult the official prescribing information and relevant clinical guidelines. Dosing and management may vary based on individual patient factors and institutional protocols. Always verify current prescribing information before making treatment decisions.*