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# Mylotarg (gemtuzumab ozogamicin) ## Overview Mylotarg is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It targets CD33-expressing cells, primarily acute myeloid leukemia (AML) blasts. ## Primary Indications * Treatment of newly diagnosed favorable-risk or intermediate-risk** acute myeloid leukemia (AML) in adult patients in combination with daunorubicin and cytarabine. * Treatment of relapsed or refractory CD33-positive AML in adult patients. **Note:** Favorable and intermediate risk are defined by genetic and cytogenetic factors. ## Adult Dosing **For newly diagnosed AML (in combination with chemotherapy):** * Administer Mylotarg at a dose of **3 mg/kg** on days 1, 4, and 7 of induction therapy. * Subsequent doses (if needed for consolidation) are **3 mg/kg** on days 1, 4, and 7 of each consolidation cycle. **For relapsed or refractory AML:** * Administer Mylotarg at a dose of **6 mg/kg** on day 1. * If disease persists or recurs, a second dose of **6 mg/kg** may be administered on day 1 of the next cycle, no sooner than 2 to 4 weeks after the first dose. **Maximum dose:** Do not exceed 6 mg/kg in a 2-week period or 9 mg/kg in a 1-month period. ## Pediatric Dosing There is **no established pediatric dosing** for Mylotarg. Use in pediatric patients is generally not recommended outside of clinical trials. ## Dose Adjustments * **Hepatic Impairment:** Use with caution. Monitor liver function tests closely. Dose adjustments may be necessary based on bilirubin levels. Specific guidelines for dose reduction in hepatic impairment are not definitively established and should be guided by clinical judgment and local protocols. * **Renal Impairment:** Use with caution. Monitor renal function. No specific dose adjustments are provided, but consider potential for increased toxicity in severe impairment. ## Contraindications * None listed in standard prescribing information. However, caution is advised in patients with severe hepatic impairment. ## Adverse Effects * **Hepatotoxicity:** Severe, potentially fatal, liver injury including sinusoidal obstruction syndrome (SOS)/veno-occlusive disease (VOD) can occur, particularly in patients who have received prior stem cell transplantation or have pre-existing hepatic impairment. * **Myelosuppression:** Including neutropenia, thrombocytopenia, anemia, and febrile neutropenia. * **Bleeding events:** Including intracranial, gastrointestinal, and pulmonary hemorrhage. * **Infusion-related reactions:** Fever, chills, rash, dyspnea. * **Nausea, vomiting, diarrhea, mucositis.** * **Hyperbilirubinemia.** ## Key Drug Interactions * **Hepatotoxic agents:** Concurrent use with other medications known to cause hepatotoxicity may increase the risk of liver injury. * **Drugs affecting bleeding risk:** Caution with anticoagulants or antiplatelet agents due to increased risk of bleeding. ## Monitoring * **Liver function tests (LFTs):** Including bilirubin, AST, ALT, and alkaline phosphatase, before and regularly during treatment. Monitor closely for signs/symptoms of SOS/VOD. * **Complete blood counts (CBCs):** With differential and platelet count, frequently during treatment to monitor for myelosuppression. * **Coagulation parameters:** PT/INR, PTT, especially if on anticoagulants or experiencing bleeding. * **Signs and symptoms of bleeding:** Including neurological, gastrointestinal, and pulmonary. * **Signs and symptoms of infusion-related reactions.** ## Clinical Pearls * Due to the significant risk of hepatotoxicity, particularly SOS/VOD, close monitoring of liver function and vigilance for clinical signs are crucial. Patients with prior stem cell transplant or hepatic impairment are at higher risk. * The risk of bleeding events necessitates careful monitoring of coagulation parameters and patient's status. * Infusion should be administered over 2 hours. Premedication with an antihistamine, corticosteroid, and antipyretic may be considered to reduce infusion-related reactions. **Disclaimer:** This information is intended for clinical use and does not replace comprehensive drug information resources. Always consult the current Prescribing Information and consider individual patient factors and local protocols before making any treatment decisions.