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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a CD33-directed antibody and cytotoxic drug conjugate for the treatment of certain types of acute myeloid leukemia (AML). It targets CD33-expressing cancer cells.
## Primary Indications
* Treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) who are ineligible for intensive induction chemotherapy.
* Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
For newly diagnosed AML ineligible for intensive induction chemotherapy:
* Administer a total of 3 doses.
* Dose 1: 3 mg/m² administered as a single intravenous infusion on Day 1.
* Dose 2: 3 mg/m² administered as a single intravenous infusion on Day 15.
* Dose 3: 3 mg/m² administered as a single intravenous infusion on Day 29.
For relapsed or refractory AML:
* Administer a total of 2 doses.
* Dose 1: 6 mg/m² administered as a single intravenous infusion on Day 1.
* Dose 2: 3 mg/m² administered as a single intravenous infusion on Day 15.
Infusion rate should be ≤ 100 mL/hour. Maximum dose per infusion is 6 mg.
## Pediatric Dosing
The efficacy and safety of Mylotarg in pediatric patients have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary.
* **Thrombocytopenia:** Dose interruption or discontinuation may be necessary.
* **Infusion Reactions:** Dose interruption or modification of infusion rate may be necessary.
## Contraindications
* None listed in standard prescribing information.
## Adverse Effects
**Severe and potentially life-threatening:**
* Hepatotoxicity (including veno-occlusive liver disease (VOD), also known as sinusoidal obstruction syndrome (SOS), hepatic failure, and hyperbilirubinemia).
* Myelosuppression (including neutropenia, thrombocytopenia, and anemia).
* Infusion reactions.
* Hemorrhage.
**Common adverse effects (≥ 20%):** Fever, nausea, vomiting, diarrhea, headache, rash, abdominal pain, mucositis, decreased appetite, cough, and fatigue.
## Key Drug Interactions
Due to the potential for hepatotoxicity, concomitant use with other hepatotoxic agents or drugs that affect liver function may increase the risk of liver injury.
## Monitoring
* **Liver function:** Monitor bilirubin, AST, ALT, and alkaline phosphatase before and regularly during treatment.
* **Complete blood counts (CBCs):** Monitor blood counts, including platelets, before treatment and regularly during treatment.
* **Signs and symptoms of infusion reactions:** Monitor for signs of hypersensitivity.
* **Signs and symptoms of hemorrhage:** Monitor for bleeding.
## Clinical Pearls
* Pre-infusion medication with an antiemetic and an antipyretic is recommended.
* Mylotarg carries a Black Box Warning for hepatotoxicity and myelosuppression.
* For patients with relapsed/refractory AML, the initial dose is higher (6 mg/m²) compared to subsequent doses (3 mg/m²).
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*Disclaimer: This information is intended for clinical pharmacy professionals and should not replace a thorough review of the most current prescribing information approved by regulatory agencies. Always verify drug information with official product labeling and institutional protocols.*
