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# Mylotarg (gemtuzumab ozogamicin) ## Overview Mylotarg is a CD33-directed antibody and DNA-binding agent used in the treatment of acute myeloid leukemia (AML). It targets the CD33 antigen, which is found on the surface of myeloid leukemia cells. ## Primary Indications * Newly diagnosed CD33-positive AML in adults, in combination with standard induction and consolidation chemotherapy. * Relapsed or refractory CD33-positive AML in adults. ## Adult Dosing **For Newly Diagnosed AML (in combination with chemotherapy):** * **First cycle:** 3 mg/kg on Day 1, 6 mg/kg on Day 4, and 6 mg/kg on Day 7. * **Subsequent cycles:** 3 mg/kg every 2 to 4 weeks. **For Relapsed or Refractory AML:** * **First cycle:** 3 mg/kg on Day 1. * **Second cycle (if tolerated and no progression):** 3 mg/kg on Day 1, administered at least 14 days after the first dose. **Maximum cumulative dose:** 18 mg/kg over the course of therapy for relapsed or refractory AML. ## Pediatric Dosing Mylotarg is not approved for use in pediatric patients. ## Dose Adjustments * **Hepatic Impairment:** Use with caution. No specific dose adjustment guidelines are established, but consider dose reduction or interruption based on clinical response and toxicity, particularly for elevated bilirubin. * **Renal Impairment:** Use with caution. No specific dose adjustment guidelines are established, but consider dose reduction or interruption based on clinical response and toxicity. ## Contraindications * None listed. ## Adverse Effects * **Hepatotoxicity:** Severe and potentially fatal liver injury, including sinusoidal obstruction syndrome (SOS)/veno-occlusive disease (VOD), has been reported. Risk factors include prior stem cell transplant, prior hepatic radiotherapy, and elevated bilirubin. * **Myelosuppression:** Including neutropenia, thrombocytopenia, anemia, and febrile neutropenia. * **Bleeding events:** Hemorrhage, including central nervous system hemorrhage. * **Infusion-related reactions:** Fever, rash, chills, dyspnea. * **Nausea, vomiting, diarrhea, mucositis, fatigue, headache, pyrexia, hypokalemia.** ## Key Drug Interactions * No significant drug interactions are identified. ## Monitoring * **Liver Function Tests:** Regularly monitor AST, ALT, alkaline phosphatase, and bilirubin before and during treatment, especially in patients with pre-existing hepatic impairment or risk factors for SOS/VOD. * **Complete Blood Counts (CBC) with differential and platelets:** Frequently monitor for myelosuppression. * **Signs and symptoms of bleeding:** Assess for any signs of hemorrhage. * **Signs and symptoms of infusion-related reactions:** Monitor during and after infusion. ## Clinical Pearls * Mylotarg carries a black box warning for hepatotoxicity, particularly SOS/VOD. Proactive monitoring and prompt management are critical. * Consider prophylactic measures for SOS/VOD if risk factors are present. * Ensure adequate hydration and manage electrolyte imbalances. * Educate patients on signs and symptoms of hepatotoxicity, bleeding, and infusion reactions. **Disclaimer:** This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always consult the most current prescribing information and relevant clinical guidelines before making treatment decisions. Verify current prescribing information with the manufacturer.