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# Mylodtat (Mylotarg / Gemtuzumab ozogamicin) ## Overview Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). It delivers a potent cytotoxic agent (calicheamicin) to CD33-positive leukemic cells. ## Primary Indications Treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients aged 1 month and older. ## Adult Dosing * **Newly Diagnosed AML (Combination therapy):** 3 mg/m² (up to a maximum dose of 4.5 mg) on days 1, 4, and 7. * **Newly Diagnosed AML (Monotherapy):** 6 mg/m² on day 1, followed by 3 mg/m² on day 8 (induction). Up to 2 cycles of 3 mg/m² (day 1 only) for consolidation. ## Pediatric Dosing * **Patients ≥1 month:** 3 mg/m² (up to a maximum dose of 4.5 mg) on days 1, 4, and 7 in combination with standard induction chemotherapy. * *Note: Doses for patients with a body surface area (BSA) <0.6 m² should be calculated based on body weight (0.1 mg/kg).* ## Dose Adjustments * **Hepatic Impairment:** No specific adjustment for mild impairment, but monitor closely for hepatotoxicity. Avoid in patients with bilirubin >2x ULN or AST/ALT >2.5x ULN. * **Renal Impairment:** No dose adjustment necessary for mild-to-moderate impairment. ## Contraindications * Known hypersensitivity to gemtuzumab ozogamicin or any of its components. * History of veno-occlusive disease (VOD; also known as sinusoidal obstruction syndrome). ## Adverse Effects * **Hematologic:** Severe neutropenia, thrombocytopenia, and anemia. * **Hepatotoxicity:** Including fatal veno-occlusive disease (VOD/SOS). * **Infusion-related:** Hypotension, dyspnea, and chills. * **Other:** Infection, stomatitis, and hemorrhage. ## Key Drug Interactions * **Hepatotoxic Agents:** Risk of additive hepatotoxicity; use with extreme caution. * **Live Vaccines:** Avoid concomitant administration due to immunosuppressive effects. ## Monitoring * **Hepatic:** Perform baseline and frequent monitoring of total bilirubin, alkaline phosphatase, ALT, and AST. Persistent elevation requires treatment interruption or discontinuation. * **Hematologic:** Monitor CBC frequently during treatment. * **Infusion:** Monitor for signs of infusion-related reactions (consider premedication with acetaminophen, diphenhydramine, and corticosteroids). ## Clinical Pearls * **VOD Risk:** The risk of VOD is significantly increased in patients undergoing hematopoietic stem cell transplantation (HSCT) post-therapy. Ensure adequate recovery periods between last dose and transplant. * **Handling:** This is a cytotoxic, light-sensitive agent. Administer protected from light during infusion. Do not use standard filters; use a dedicated low-protein binding 0.2-micron filter. * **Pregnancy:** Females of reproductive potential must use effective contraception during treatment and for at least 6 months after the last dose. *** *Disclaimer: This information is for educational purposes only. Always consult your institution’s specific clinical protocols and the official FDA-approved package insert (Prescribing Information) for the most current dosing, safety warnings, and contraindications before prescribing or administering any medication.*