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## Overview Mylotarg (gemtuzumab ozogamicin) is a targeted immunoconjugate that binds to CD33 antigens, which are present on myeloid leukemia cells, and releases calicheamicin, an antitumor antibiotic, to induce cell death. ## Primary Indications Treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adult patients in combination with chemotherapy, and for relapsed or refractory CD33-positive AML in adult patients. ## Adult Dosing * **For newly diagnosed CD33-positive AML (in combination with chemotherapy):** * Day 1: 3 mg/m² IV infusion. * Day 4: 3 mg/m² IV infusion. * Day 7: 2 mg/m² IV infusion. * **For relapsed or refractory CD33-positive AML:** * First cycle: 6 mg/m² IV infusion on Day 1. If tolerated, a second cycle can be given on Day 4 (total dose 3 mg/m² IV infusion). * Second cycle (if given): 3 mg/m² IV infusion on Day 1 and Day 4. * *Maximum dose per infusion: 6 mg* ## Pediatric Dosing Dosing in pediatric patients is not established. ## Dose Adjustments * **Hepatic Impairment:** Use with caution. No specific dose adjustment recommendations, but monitor closely for toxicity. * **Renal Impairment:** Use with caution. No specific dose adjustment recommendations, but monitor closely for toxicity. ## Contraindications None listed. ## Adverse Effects The most common adverse effects include: * **Hematologic:** Febrile neutropenia, thrombocytopenia, anemia, neutropenia, leukopenia. * **Gastrointestinal:** Nausea, vomiting, diarrhea, mucositis, constipation. * **General:** Fever, headache, chills, fatigue, rash, cough, hypokalemia. * **Serious:** **Hepatotoxicity** (including sinusoidal obstruction syndrome/veno-occlusive disease), **myelosuppression**, **infusion-related reactions**, **hemorrhage**, **tumor lysis syndrome**. ## Key Drug Interactions * **Live Vaccines:** Avoid concurrent use due to immunosuppressive effects. ## Monitoring * **Hepatic function:** Monitor ALT, AST, bilirubin, and alkaline phosphatase regularly, especially before and during treatment. Discontinue or delay treatment for signs of hepatotoxicity. * **Hematologic parameters:** Monitor complete blood counts (CBC) with differential and platelet counts frequently. * **Renal function:** Monitor serum creatinine and electrolytes. * **Signs of infusion-related reactions:** Monitor vital signs during and after infusion. * **Signs of bleeding:** Monitor for any signs or symptoms of bleeding. ## Clinical Pearls * Hepatotoxicity, particularly sinusoidal obstruction syndrome (SOS), is a serious and potentially fatal adverse effect. Risk factors include prior stem cell transplant, prior gemtuzumab ozogamicin therapy, and elevated bilirubin. * Myelosuppression is expected and requires vigilant monitoring and management. * Infusion reactions can occur. Premedication may be considered per local protocol. *** **Disclaimer:** This information is intended for clinical use and is not a substitute for professional medical advice. Always consult the most current prescribing information and guidelines, and exercise your professional judgment when making therapeutic decisions. Dosing and management may vary based on individual patient factors and local protocols.