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# Mylotarg (gemtuzumab ozogamicin) ## Overview Mylotarg is a targeted therapy, specifically an antibody-drug conjugate, that targets CD33-expressing cells. It is used in the treatment of acute myeloid leukemia (AML). ## Primary Indications * Treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adult patients. * Treatment of relapsed or refractory CD33-positive acute myeloid leukemia (AML) in adult patients. ## Adult Dosing **Newly Diagnosed CD33-positive AML:** * **First course:** 3 mg/m² on days 1, 4, and 7. If tolerated, a second course may be given. * **Second course:** 3 mg/m² on days 1, 4, and 7. * **Maximum cumulative dose:** 33 mg/m². **Relapsed or Refractory CD33-positive AML:** * **First course:** 6 mg/m² on day 1. If tolerated, a second course may be given. * **Second course:** 3 mg/m² on day 1. * **Maximum cumulative dose:** 33 mg/m². Note: Dosing can be adjusted based on patient tolerance and specific protocols. ## Pediatric Dosing The safety and efficacy of Mylotarg in pediatric patients have not been established. ## Dose Adjustments * **Hepatotoxicity:** Dose interruption or reduction may be necessary. If bilirubin > 2 mg/dL or AST/ALT > 2 times the upper limit of normal, delay treatment. Resume at a reduced dose if liver function improves. * **Thrombocytopenia:** Monitor platelet counts closely. Dose modification may be required based on nadir and recovery. ## Contraindications * None listed. ## Adverse Effects * **Hepatotoxicity:** Including veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS). This is a serious and potentially fatal adverse effect. * **Myelosuppression:** Including neutropenia, thrombocytopenia, and anemia. * Nausea, vomiting, diarrhea, mucositis, fever, fatigue, rash. * Infusion-related reactions. ## Key Drug Interactions * No specific drug interactions are listed. However, concomitant use with other myelosuppressive agents may increase the risk of myelosuppression. ## Monitoring * **Liver function tests:** Including bilirubin, AST, and ALT, especially before and during treatment. * **Complete blood counts:** Including platelet counts, white blood cell counts, and hemoglobin, frequently throughout treatment. * Signs and symptoms of VOD/SOS (e.g., jaundice, right upper quadrant pain, ascites, hepatomegaly). ## Clinical Pearls * Mylotarg carries a Black Box Warning for hepatotoxicity, including VOD/SOS. * Close monitoring for signs of VOD/SOS is critical, as early recognition and intervention can improve outcomes. * Ensure adequate hydration and supportive care for nausea, vomiting, and mucositis. * Dosing decisions should be made in conjunction with hematology/oncology and based on patient-specific factors and clinical trial data. *** *Disclaimer: This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always consult the most current prescribing information, guidelines, and consult with a qualified healthcare provider for any medical condition or treatment. Dosing and management may vary based on individual patient factors and institutional protocols.*