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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate consisting of a humanized antibody that targets CD33, conjugated to the cytotoxic agent calicheamicin. It is indicated for the treatment of acute myeloid leukemia (AML).
## Primary Indications
* Newly diagnosed CD33-positive AML in adult patients in combination with chemotherapy.
* CD33-positive AML in adult patients who have relapsed or are refractory and have not undergone prior stem cell transplantation.
## Adult Dosing
**Combination Therapy for Newly Diagnosed AML:**
* **Induction:** 3 mg/m² on days 1, 4, and 7. If hypomethylating agent is used, 6 mg/m² on day 1, 4, and 7.
* **Consolidation:** Up to 4 cycles of 3 mg/m² on day 1.
**Relapsed/Refractory AML:**
* **First Cycle:** 6 mg/m² on day 1.
* **Second Cycle (if needed):** 3 mg/m² on day 1. Dosing should be at least 2 weeks apart.
## Pediatric Dosing
The safety and efficacy of Mylotarg have not been established in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** Withhold Mylotarg if AST > 5 times the upper limit of normal (ULN) or total bilirubin > 2 times ULN. Resume at a reduced dose (3 mg/m²) if recovery occurs.
* **Thrombocytopenia:** Withhold if platelet count < 50,000/µL. Resume at the same or reduced dose when platelets recover.
* **Neutropenia:** Consider growth factor support.
## Contraindications
* None listed.
## Adverse Effects
* **Common:** Febrile neutropenia, nausea, vomiting, diarrhea, mucositis, headache, rash, fatigue, cough, abdominal pain, constipation, decreased appetite.
* **Serious:** Hepatotoxicity (Veno-occlusive disease/Sinusoidal obstruction syndrome), myelosuppression (including severe thrombocytopenia and neutropenia), bleeding events, hypersensitivity reactions.
## Key Drug Interactions
* **Hepatotoxic Agents:** Concomitant use with other drugs known to cause hepatotoxicity may increase the risk of liver injury. Careful monitoring is required.
## Monitoring
* **Complete Blood Counts (CBC):** Monitor frequently, especially for neutropenia and thrombocytopenia.
* **Liver Function Tests (LFTs):** Monitor AST, ALT, and bilirubin.
* **Signs of Bleeding:** Monitor for petechiae, ecchymoses, epistaxis, hematuria, etc.
* **Signs of Hypersensitivity:** Monitor for rash, pruritus, dyspnea, hypotension.
## Clinical Pearls
* Mylotarg carries a boxed warning for hepatotoxicity, particularly veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), especially in patients who have undergone stem cell transplantation or have moderate to severe hepatic impairment.
* Administer as a 2-hour infusion.
* Premedication for nausea/vomiting and hypersensitivity is recommended.
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**Disclaimer:** This information is intended for healthcare professionals. It is essential to consult the most current prescribing information and institutional guidelines for definitive dosing and management.
