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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a humanized antibody-drug conjugate that targets CD33, a protein found on the surface of myeloid leukemia cells.
## Primary Indications
* Treatment of newly diagnosed acute myeloid leukemia (AML) in adults in combination with chemotherapy.
* Treatment of relapsed or refractory AML in adults.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* **Course 1:** 3 mg/m² as a single IV infusion on day 4 of induction chemotherapy, and on day 4 of each consolidation chemotherapy cycle.
* **Subsequent Courses:** 3 mg/m² as a single IV infusion on day 4 of each consolidation chemotherapy cycle.
* A maximum of 4 cycles (2 induction cycles and 2 consolidation cycles) can be administered.
**Relapsed or Refractory AML:**
* 6 mg/m² as a single IV infusion on day 1 of the first cycle.
* If treatment is continued, 3 mg/m² as a single IV infusion on day 1 of subsequent cycles.
* A maximum of 4 cycles can be administered. A minimum of 14 days should elapse between cycles.
Doses are administered over 2 hours.
## Pediatric Dosing
Dosing in pediatric patients has not been established.
## Dose Adjustments
* **Hepatotoxicity:** Discontinue treatment if AST/ALT > 5 times the upper limit of normal. Consider continuation if it resolves to Grade 1 or less.
* **Thrombocytopenia:** Hold treatment if platelets < 50,000/mcL. Resume when platelets recover to appropriate levels (consult prescribing information for specific recovery thresholds).
* **Myelosuppression:** Monitor blood counts closely. Dose adjustments are often guided by hematologic recovery and local institutional protocols.
## Contraindications
* None listed in prescribing information.
## Adverse Effects
Common adverse effects include:
* Hepatotoxicity (including veno-occlusive disease/sinusoidal obstruction syndrome)
* Aplastic anemia
* Hemorrhage
* Febrile neutropenia
* Thrombocytopenia
* Nausea and vomiting
* Mucositis
* Pyrexia
* Headache
* Hyperglycemia
## Key Drug Interactions
* **Hepatotoxic agents:** Caution when used concurrently with other potentially hepatotoxic medications due to increased risk of liver injury.
## Monitoring
* Liver function tests (AST, ALT, bilirubin) prior to and regularly during treatment.
* Complete blood counts (CBC) with differential and platelet count frequently during and after treatment.
* Monitor for signs and symptoms of bleeding and VOD/SOS.
## Clinical Pearls
* Premedication is typically recommended to reduce infusion-related reactions.
* Dilute Mylotarg in 0.9% Sodium Chloride Injection. Do not use dextrose solutions.
* Administer over 2 hours.
* Patients receiving Mylotarg are at increased risk of hepatotoxicity, particularly VOD/SOS, which can be severe and fatal.
*This drug information is intended for clinical pharmacists and healthcare professionals. It is essential to consult the most current prescribing information and institutional protocols for complete details and to ensure patient-specific care.*
