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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin 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 adult patients with newly diagnosed Acute Myeloid Leukemia (AML) who are suitable for intensive chemotherapy.
* Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* **First cycle:** 3 mg/m² on days 1, 4, and 7.
* **Second cycle (if given):** 3 mg/m² on days 1 and 4.
* **Subsequent cycles (if given):** 3 mg/m² on day 1.
**Relapsed or Refractory AML:**
* **First cycle:** 3 mg/m² on day 1.
* **Second cycle (if given):** 3 mg/m² on day 1.
* **Third cycle (if given):** May consider 3 mg/m² on day 1.
**Maximum cumulative dose:** 13.8 mg/m² over the course of therapy.
## Pediatric Dosing
Safety and efficacy have not been established in pediatric patients.
## Dose Adjustments
* **Hepatic Impairment:** Dose reduction may be necessary. Consult specific guidelines or prescribing information for detailed recommendations based on bilirubin levels.
* **Infusion Reactions:** Interrupt infusion, manage symptoms. If symptoms resolve, may resume at a slower rate. If severe, discontinue.
* **Veno-occlusive Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS):** Discontinue treatment.
## Contraindications
* None listed in standard prescribing information, but hypersensitivity to gemtuzumab ozogamicin or its components is a contraindication.
## Adverse Effects
* **Hepatotoxicity:** Including VOD/SOS, characterized by hyperbilirubinemia, hepatomegaly, ascites, and coagulopathy.
* **Myelosuppression:** Neutropenia, thrombocytopenia, anemia, and febrile neutropenia.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, stomatitis.
* **Hemorrhage:** Especially in patients with severe thrombocytopenia.
* **Infections:** Due to neutropenia.
## Key Drug Interactions
* **Strong CYP3A4 inhibitors/inducers:** May affect the metabolism of calicheamicin, although direct clinical significance is uncertain. Monitor for increased toxicity or reduced efficacy.
* **Other myelosuppressive agents:** Increased risk of myelosuppression.
## Monitoring
* **Liver function tests (LFTs):** Including bilirubin, AST, ALT, alkaline phosphatase, INR prior to and regularly during treatment.
* **Complete Blood Count (CBC) with differential and platelet count:** Prior to and regularly during treatment.
* **Signs and symptoms of infusion reactions:** During and after infusion.
* **Signs and symptoms of VOD/SOS:** Especially in patients with risk factors (e.g., prior HCT, liver disease).
* **Signs and symptoms of bleeding:** Particularly if platelet counts are low.
## Clinical Pearls
* The maximum cumulative dose of 13.8 mg/m² should not be exceeded due to increased risk of severe hepatotoxicity.
* Close monitoring for hepatotoxicity, especially VOD/SOS, is critical. Symptoms can be insidious.
* Consider prophylaxis for febrile neutropenia and bleeding based on patient-specific risk factors and institutional protocols.
* May be administered intravenously over 2 hours.
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*This information is intended for healthcare professionals. Please refer to the official prescribing information for Mylotarg for complete details and consult current clinical guidelines and institutional protocols for patient-specific management.*
