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# Mylotarg (gemtuzumab ozogamicin) ## Overview Gemtuzumab ozogamicin is an antibody-drug conjugate (ADC) consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It targets CD33-expressing myeloid cells, including leukemic blasts. ## Primary Indications * Treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) who are 75 years of age or older. * Treatment of adult patients with relapsed or refractory AML. ## Adult Dosing **Newly Diagnosed CD33-positive AML (in combination with daunorubicin and cytarabine):** * Day 1: 3 mg/kg IV infusion over 2 hours. * Day 4: 3 mg/kg IV infusion over 2 hours. * Day 7: 2 mg/kg IV infusion over 2 hours. **Relapsed or Refractory CD33-positive AML:** * First cycle: 6 mg/kg IV infusion over 2 hours on Day 1. If treatment is not stopped due to toxicity, a second cycle is given on Day 4 with 3 mg/kg IV infusion over 2 hours. * Second cycle (if applicable): 3 mg/kg IV infusion over 2 hours on Day 4. **Maximum cumulative dose should not exceed 27 mg/m² (approximately 10 mg/kg, assuming an average BSA).** ## Pediatric Dosing There is no established pediatric dosing. ## Dose Adjustments * **Hepatotoxicity:** Dose interruption or discontinuation may be necessary. See Contraindications and Adverse Effects for details. * **Thrombocytopenia:** Dose interruption or discontinuation may be necessary. ## Contraindications * Known hypersensitivity to gemtuzumab ozogamicin or any component of the formulation. * Active NSMutableArray bleeding. * Concurrent administration with other calicheamicin-containing agents. ## Adverse Effects * **Hepatotoxicity:** Severe, potentially fatal, liver damage including veno-occlusive liver disease (VOD)/sinusoidal obstruction syndrome (SOS) has been reported. Risk factors include prior stem cell transplant, prior liver radiation, and elevated bilirubin or AST at baseline. * **Myelosuppression:** Severe thrombocytopenia, neutropenia, and anemia are common. * **Infusion-related reactions:** Fever, chills, rash, dyspnea. * **Gastrointestinal:** Nausea, vomiting, diarrhea, stomatitis. * **Bleeding events.** * **Infections:** Sepsis, pneumonia. ## Key Drug Interactions * **Other myelosuppressive agents:** Increased risk of myelosuppression. * **Hepatotoxic agents:** Increased risk of hepatotoxicity. ## Monitoring * **Liver function tests (LFTs):** Bilirubin, AST, ALT, alkaline phosphatase, coagulation parameters, particularly before and during treatment. * **Complete blood count (CBC) with differential:** Prior to each dose, weekly, and as clinically indicated. * **Signs and symptoms of infusion-related reactions and bleeding.** * **Signs and symptoms of VOD/SOS.** ## Clinical Pearls * Due to the risk of severe hepatotoxicity, careful patient selection and close monitoring are crucial. * Pre-hydration and premedication with an antipyretic and antihistamine may be considered for infusion-related reactions. * Monitor for signs of bleeding, especially if thrombocytopenia is present. *** **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 your institution's protocols for definitive guidance.