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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a CD33-positive antibody-drug conjugate for the treatment of acute myeloid leukemia (AML).
## Primary Indications
* Treatment of newly diagnosed CD33-positive AML in adults in combination with induction and consolidation chemotherapy.
* Treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 1 month and older.
## Adult Dosing
**Newly Diagnosed CD33-positive AML (combination therapy):**
* **Induction (first cycle):** 3 mg/kg on day 1, 6 mg/kg on day 4, and 6 mg/kg on day 7.
* **Induction (second cycle, if needed):** 3 mg/kg on day 1.
* **Consolidation:** 3 mg/kg within 90 days of achieving complete remission.
* **Maximum cumulative dose:** 27 mg/kg.
**Relapsed or Refractory CD33-positive AML:**
* **First cycle:** 6 mg/kg on day 1 and 6 mg/kg on day 4.
* **Second cycle (if needed):** 3 mg/kg on day 1.
* **Maximum cumulative dose:** 27 mg/kg.
## Pediatric Dosing
* **Relapsed or Refractory CD33-positive AML:** 6 mg/kg on day 1 and day 4 for the first cycle; 3 mg/kg on day 1 for the second cycle if chemotherapy is given.
* **Maximum cumulative dose:** 27 mg/kg.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruptions or reductions may be necessary based on ALT, AST, or bilirubin levels. Refer to prescribing information for specific management guidelines.
* **Posterior Reversible Encephalopathy Syndrome (PRES):** Discontinue Mylotarg permanently.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any of its components.
## Adverse Effects
* **Common:** Febrile neutropenia, nausea, vomiting, diarrhea, stomatitis, headache, rash, fatigue, mucositis, pyrexia, elevated transaminases, hyperbilirubinemia, and hypokalemia.
* **Serious:** Hepatotoxicity (including VOD/SOS), myelosuppression, infusion reactions, tumor lysis syndrome, and PRES.
## Key Drug Interactions
* No specific drug interactions are identified in the prescribing information, but caution is advised with other myelosuppressive agents.
## Monitoring
* Complete blood counts (CBC) with differential and platelet count.
* Liver function tests (ALT, AST, bilirubin).
* Renal function.
* Signs and symptoms of infusion reactions, hypersensitivity, VOD/SOS, PRES, and tumor lysis syndrome.
## Clinical Pearls
* Administer as a 2-hour infusion. Dosing is typically given intravenously over 2 hours.
* Premedication with an antiemetic and corticosteroid is recommended to mitigate infusion reactions.
* Close monitoring for hepatotoxicity, especially veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), is crucial, particularly in patients with pre-existing hepatic impairment or those receiving intensive chemotherapy.
* Monitor for signs of PRES.
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*This information is intended for healthcare professionals. Always consult the current official prescribing information and local protocols for complete details before making clinical decisions.*
