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# Mylotarg (gemtuzumab ozogamicin) ## Overview Mylotarg is a targeted immunoconjugate consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic antibiotic calicheamicin. It is designed to deliver a potent cytotoxic agent directly to cancer cells expressing the CD33 antigen. ## Primary Indications * Treatment of newly diagnosed acute myeloid leukemia (AML) in adult patients who are not eligible for intensive induction chemotherapy. * Treatment of relapsed or refractory AML in adult patients. ## Adult Dosing **Newly Diagnosed AML (not eligible for intensive induction chemotherapy):** * **Day 1:** 3 mg/m² intravenously over 2 hours. * **Day 4:** 3 mg/m² intravenously over 2 hours. * **Day 7:** 2 mg/m² intravenously over 2 hours. * **Subsequent cycles (if needed):** 2 mg/m² intravenously over 2 hours every 2 to 3 weeks. **Relapsed or Refractory AML:** * **Cycle 1:** 6 mg/m² intravenously over 2 hours on Day 1. If not progressing or relapsing, a second cycle of 3 mg/m² intravenously over 2 hours on Day 1 can be administered approximately 2 to 4 weeks after Cycle 1. *Note: Local protocols may dictate specific dosing or treatment schedules.* ## Pediatric Dosing The safety and efficacy of Mylotarg have not been established in pediatric patients. ## Dose Adjustments * **Hepatotoxicity:** Dose interruption or reduction may be necessary. * If AST/ALT > 3 times ULN: Hold dose. Resume at 3 mg/m² or 2 mg/m² if previously reduced. * If bilirubin > 2 times ULN: Hold dose. Resume at 3 mg/m² or 2 mg/m² if previously reduced. * If total bilirubin > 3 mg/dL: Permanently discontinue. * **Myelosuppression:** Dose interruption or delay may be necessary. Monitor blood counts closely. * **Infusion Reactions:** Slow infusion rate, administer premedications, or discontinue based on severity. ## Contraindications * None listed. ## Adverse Effects * **Hepatotoxicity:** Severe, potentially fatal, including sinusoidal obstruction syndrome (SOS)/recurrent hepatic veno-occlusive disease (HVOD). * **Myelosuppression:** Neutropenia, thrombocytopenia, anemia, febrile neutropenia. * **Infusion Reactions:** Fever, rash, chills, dyspnea, hypotension. * **Hemorrhage:** Including gastrointestinal and intracranial. * **Nausea, vomiting, diarrhea, stomatitis.** * **Fatigue, headache, pyrexia.** ## Key Drug Interactions * No significant drug interactions are identified. However, caution with other myelosuppressive agents due to additive effects. ## Monitoring * **Liver Function Tests (LFTs):** Including AST, ALT, alkaline phosphatase, and bilirubin regularly, especially before and during treatment. * **Complete Blood Counts (CBCs):** Including differential and platelet count, before, during, and after treatment. * **Signs and symptoms of infusion reactions.** * **Signs and symptoms of bleeding.** * **Signs and symptoms of SOS/HVOD:** Monitor for weight gain, ascites, hepatomegaly, and jaundice. ## Clinical Pearls * Mylotarg carries a black box warning for hepatotoxicity, including fatal SOS/HVOD. Close monitoring of liver function is critical. * Premedication with corticosteroids, antihistamines, and antipyretics may help prevent infusion reactions. * Infusion rate should be adjusted based on patient tolerance. * Early recognition and management of SOS/HVOD are crucial. *** *This information is intended for healthcare professionals and should not be a substitute for professional medical advice. Always consult the most current prescribing information and your institution's protocols before making any treatment decisions.*