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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a targeted antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It is indicated for the treatment of certain types of acute myeloid leukemia (AML).
## Primary Indications
* **Newly diagnosed AML:** In combination with chemotherapy for patients with *de novo* AML, or for patients with relapsed or refractory AML.
* **Relapsed or Refractory AML:** As a single agent for patients with relapsed or refractory AML.
## Adult Dosing
* **Newly Diagnosed AML (in combination with chemotherapy):**
* Day 1: 3 mg/m² IV infusion over 2 hours.
* Day 4: 3 mg/m² IV infusion over 2 hours.
* Day 7: 2 mg/m² IV infusion over 2 hours.
* Subsequent cycles: 3 mg/m² IV infusion over 2 hours every 2 weeks.
* Maximum dose per infusion: 4.5 mg.
* *Note:* Dosing depends on the specific chemotherapy regimen and local institutional protocol.
* **Relapsed or Refractory AML (single agent):**
* First course: 6 mg/m² IV infusion over 2 hours on Day 1.
* If no unacceptable toxicity, a second course may be given at 3 mg/m² IV infusion over 2 hours on Day 1, at least 14 days after the first infusion.
* Maximum dose per infusion: 4.5 mg.
## Pediatric Dosing
Safety and efficacy in pediatric patients have not been established.
## Dose Adjustments
* **Hepatotoxicity:**
* If aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN), or total bilirubin > 2 times ULN: Delay treatment and monitor.
* If AST or ALT > 5 times ULN, or total bilirubin > 3 times ULN: Consider withholding or discontinuing treatment. Refer to specific prescribing information for detailed management guidelines.
* **Thrombocytopenia:**
* If platelet count < 30,000/µL or Grade 3/4 bleeding: Delay treatment.
* Resumption of treatment should be based on recovery of platelet count and resolution of bleeding.
* **Febrile Neutropenia:**
* Consider withholding treatment.
* Resumption of treatment should be based on resolution of fever and recovery of neutrophil count.
## Contraindications
* None established.
## Adverse Effects
* **Serious:** Hepatotoxicity (including VOD/SOS), myelosuppression (including thrombocytopenia, neutropenia, anemia), bleeding events, hypersensitivity reactions, tumor lysis syndrome.
* **Common:** Febrile neutropenia, thrombocytopenia, anemia, nausea, vomiting, diarrhea, mucositis, fatigue, headache, rash, pyrexia.
## Key Drug Interactions
* **Concurrent chemotherapy:** Increased risk of myelosuppression and other toxicities. Close monitoring is essential.
* **Other hepatotoxic agents:** Increased risk of hepatotoxicity.
## Monitoring
* **Hepatotoxicity:** Baseline and regular monitoring of liver function tests (AST, ALT, bilirubin).
* **Hematologic:** Complete blood counts (CBC) with differential and platelet count before each dose and as clinically indicated.
* **Bleeding:** Monitor for signs and symptoms of bleeding.
* **Hypersensitivity:** Monitor for signs and symptoms of infusion-related reactions.
* **VOD/SOS:** Monitor for signs and symptoms of veno-occlusive disease/sinusoidal obstruction syndrome.
## Clinical Pearls
* Mylotarg's efficacy is linked to CD33 expression on leukemia cells.
* Serious hepatotoxicity, particularly VOD/SOS, is a significant concern. Patients with pre-existing hepatic impairment may be at higher risk.
* Close monitoring for myelosuppression and bleeding is crucial.
* Premedication may be considered to manage infusion-related reactions.
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**Disclaimer:** This information is intended for healthcare professionals. Always refer to the most current prescribing information and institutional guidelines for complete details on dosing, administration, safety, and contraindications.
