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# Mylotarg (gemtuzumab ozogamicin) ## Overview Mylotarg is an antibody-drug conjugate that targets CD33, a protein found on the surface of myeloid leukemia cells. It delivers a cytotoxic agent (calicheamicin) directly to these cells. ## Primary Indications * Treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy. * Treatment of adults with relapsed or refractory AML. ## Adult Dosing **Newly Diagnosed AML (Ineligible for Intensive Induction Chemotherapy):** * **Cycle 1:** 3 mg/m² on days 1, 4, and 7. * **Cycle 2:** 3 mg/m² on day 1. * **Cycle 3 (if applicable):** 3 mg/m² on day 1. * Doses are typically administered every 28 days. **Relapsed or Refractory AML:** * **Day 1:** 3 mg/m² * **Day 4:** 3 mg/m² * **Day 7:** 2 mg/m² * Administered in the first cycle. If patient achieves hematologic remission, a second cycle may be given at 3 mg/m² (IV) on day 1 of a 28-day cycle. **Maximum cumulative dose:** 60 mg/m² (This limit is critical due to the risk of veno-occlusive disease/sinusoidal obstruction syndrome). ## Pediatric Dosing Mylotarg is not approved for pediatric patients. Its use in pediatrics is investigational and should only be considered within clinical trials under expert guidance. ## Dose Adjustments * **Hepatic Impairment:** Use with caution. Data is limited. Consider dose reduction or interruption. * **Renal Impairment:** Data is limited. Use with caution. ## Contraindications * None listed in standard prescribing information, but use is contraindicated in patients with hypersensitivity to gemtuzumab ozogamicin or any component of the formulation. ## Adverse Effects **Serious and potentially life-threatening:** * **Hepatotoxicity:** Veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) is a major concern, particularly with higher cumulative doses. Symptoms include jaundice, hepatomegaly, ascites, and elevated bilirubin. * **Myelosuppression:** Severe neutropenia, thrombocytopenia, and anemia can occur, leading to increased risk of infections and bleeding. * **Hemorrhage:** Especially in patients with severe thrombocytopenia. * **Infusion-related reactions:** Including fever, chills, rash, and dyspnea. * **Embryo-fetal toxicity:** Due to potential harm to the developing fetus. **Common:** * Fever, nausea, vomiting, diarrhea, stomatitis, headache, fatigue, rash, hypokalemia, elevated liver enzymes. ## Key Drug Interactions * **Myelosuppressive Agents:** Concomitant use with other myelosuppressive agents (e.g., chemotherapy) may increase the risk and severity of myelosuppression. * **Hepatotoxic Agents:** Concomitant use with other hepatotoxic agents may increase the risk of liver toxicity. ## Monitoring * **Liver Function Tests (LFTs):** Including bilirubin, AST, ALT, and alkaline phosphatase, prior to each dose and as clinically indicated. Monitor closely for signs of VOD/SOS. * **Complete Blood Count (CBC) with differential and platelets:** Prior to each dose and as clinically indicated to monitor for myelosuppression. * **Signs and Symptoms of Infusion Reactions:** Monitor during and after infusion. * **Signs and Symptoms of Bleeding and Infection:** Closely monitor. * **Pregnancy Status:** Women of childbearing potential should have a negative pregnancy test prior to starting treatment. ## Clinical Pearls * Mylotarg has a **boxed warning for hepatotoxicity (VOD/SOS)** and **myelosuppression**. * The **maximum cumulative dose of 60 mg/m² must not be exceeded** due to increased risk of VOD/SOS. * Close monitoring of liver function and blood counts is paramount. * Educate patients on signs and symptoms of VOD/SOS, bleeding, and infection. * Consider prophylactic measures for mucositis and infections based on institutional protocols. * Pregnancy prevention is crucial for women of childbearing potential. *** **Disclaimer:** This information is intended for clinical decision support and does not replace professional judgment. Always consult the most current official prescribing information and relevant literature before making treatment decisions. Dosing may vary based on institutional protocols and individual patient factors.