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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. It delivers an anti-cancer drug (calicheamicin) directly to CD33-expressing 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 and pediatric patients aged 1 year and older.
## Adult Dosing
* **Newly Diagnosed AML (in combination):**
* First course: 3 mg/kg on day 4, 6, and 8 of induction chemotherapy, and on day 4 of each consolidation chemotherapy cycle.
* Second course (if achieving remission): 3 mg/kg on day 4, 6, and 8.
* Maximum dose: 3 mg/kg per administration.
* **Relapsed or Refractory AML:**
* First cycle: 6 mg/kg on day 1, and 3 mg/kg on day 4 and 7.
* Second cycle (if achieving remission): 3 mg/kg on day 1, 4, and 7.
* Maximum dose: 6 mg/kg per administration.
## Pediatric Dosing
* **Relapsed or Refractory AML (1 year and older):**
* Per local protocol, but generally follows adult dosing, with careful consideration for body surface area. A total dose of 10 mg/m² over up to 4 cycles using a reduced dose schedule is often used.
* Day 1: 3 mg/kg (or 6 mg/m²)
* Day 4: 3 mg/kg (or 6 mg/m²)
* Day 7: 2 mg/kg (or 4 mg/m²)
* Subsequent cycles (if indicated): 3 mg/kg (or 6 mg/m²) administered on days 1, 4, and 7.
* Maximum dose: 10 mg/m² per cycle.
## Dose Adjustments
* Discontinue treatment if severe (grade 3 or 4) hepatic toxicity occurs.
* Refer to prescribing information for specific guidance on managing hematologic toxicity, particularly thrombocytopenia and neutropenia, and non-hematologic toxicities (e.g., hepatobiliary events, veno-occlusive disease).
## Contraindications
* Hypersensitivity to gemtuzumab ozogamicin or any of its components.
## Adverse Effects
* **Black Box Warnings:** Hepatotoxicity (including liver failure and VOD/SOS), myelosuppression (including fatal cases).
* **Common:** Thrombocytopenia, neutropenia, febrile neutropenia, anemia, leukopenia, nausea, vomiting, diarrhea, stomatitis, fatigue, headache, pyrexia, rash, elevated liver enzymes.
* **Serious:** Hepatotoxicity (VOD/SOS), hyperbilirubinemia, pancreatitis, tumor lysis syndrome.
## Key Drug Interactions
No specific drug interactions with gemtuzumab ozogamicin have been established. However, caution is advised when co-administering with other myelosuppressive agents.
## Monitoring
* **Prior to and during treatment:** Complete blood counts (CBC) with differential and platelet count, liver function tests (LFTs), coagulation studies.
* Monitor closely for signs and symptoms of hepatotoxicity, particularly VOD/SOS (e.g., weight gain, jaundice, hepatomegaly, ascites, splenomegaly, coagulopathy).
## Clinical Pearls
* Dosing can be complex and may be based on local institutional protocols, especially in pediatric patients.
* Emphasis on meticulous monitoring for severe hepatotoxicity and myelosuppression is critical.
* Premedication with corticosteroids and antihistamines may be considered to mitigate infusion-related reactions.
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*This information is intended for clinical pharmacists and healthcare professionals. It is essential to consult the most current prescribing information for Mylotarg (gemtuzumab ozogamicin) and institutional guidelines before administering the medication, as recommendations may vary.*
