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# Mylotarg (gemtuzumab ozogamicin) ## Overview Mylotarg is an antibody-drug conjugate targeting CD33, a protein found on most leukemia cells in acute myeloid leukemia (AML). It delivers calicheamicin, a cytotoxic agent, directly to CD33-expressing cells. ## Primary Indications * Treatment of newly diagnosed adults with CD33-positive acute myeloid leukemia (AML). * Treatment of relapsed or refractory CD33-positive acute myeloid leukemia (AML) in adults and in pediatric patients 1 year and older. ## Adult Dosing * **Newly Diagnosed CD33-positive AML:** * **Induction:** 3 mg/m² on days 1, 4, and 7. A second cycle may be given on days 1, 4, and 7 if aplasia has resolved. * **Consolidation:** 3 mg/m² once every 2 weeks for up to 4 cycles. * **Relapsed or Refractory CD33-positive AML:** * **First Relapse:** 3 mg/m² on day 1. A second dose of 3 mg/m² may be given on day 8. * **Second or Later Relapse:** 3 mg/m² on day 1. ## Pediatric Dosing * **Relapsed or Refractory CD33-positive AML (1 year and older):** * **First Relapse:** 3 mg/m² on day 1. A second dose of 3 mg/m² may be given on day 8. * **Second or Later Relapse:** 3 mg/m² on day 1. ## Dose Adjustments * **Hepatic Impairment:** No specific dose adjustment, but monitor closely. Mylotarg is largely cleared by the liver. Consider dose reduction or withholding for severe hepatic impairment. * **Renal Impairment:** No specific dose adjustment, but monitor closely. ## Contraindications * None listed. ## Adverse Effects * **Common:** Nausea, vomiting, diarrhea, mucositis, headache, fever, rash, fatigue, abdominal pain, constipation, cough, chills, decreased appetite, muscle spasms. * **Serious:** Hepatotoxicity (including veno-occlusive disease/sinusoidal obstruction syndrome), myelosuppression (thrombocytopenia, neutropenia, febrile neutropenia), infusion-related reactions, bleeding events, embryo-fetal toxicity. ## Key Drug Interactions * **Strong CYP3A4 Inhibitors/Inducers:** Theoretical risk of altered clearance of the cytotoxic component; monitor closely. * **Other Myelosuppressive Agents:** Additive myelosuppression is expected. ## Monitoring * **Complete Blood Counts (CBC) with differential and platelet count:** Frequently, especially during induction and consolidation, to monitor for myelosuppression. * **Liver Function Tests (LFTs):** Baseline and regularly, especially for signs of hepatotoxicity and VOD/SOS. * **Renal Function Tests:** Baseline and regularly. * **Signs and symptoms of infusion-related reactions and bleeding.** * **Pregnancy testing:** For females of reproductive potential. ## Clinical Pearls * Hepatotoxicity, including VOD/SOS, is a serious and potentially fatal toxicity. Risk factors include prior stem cell transplant, hepatic impairment, and concomitant gemtuzumab ozogamicin. * Myelosuppression is expected and dose-limiting. Prophylactic antibiotics, antivirals, and antifungals may be considered per institutional guidelines. * Due to the risk of embryo-fetal toxicity, counsel patients of reproductive potential on the risks and need for effective contraception. *** **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 institutional guidelines before making any treatment decisions.