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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It targets CD33-expressing cells, primarily acute myeloid leukemia (AML) cells.
## Primary Indications
* Treatment of newly diagnosed adult patients with acute myeloid leukemia (AML) in combination with chemotherapy.
* Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (in combination with chemotherapy):**
* **First Cycle:** 3 mg/m² on day 1, 6 mg/m² on day 4, and 6 mg/m² on day 7.
* **Subsequent Cycles:** 6 mg/m² on day 1 of each cycle.
**Relapsed or Refractory AML:**
* **First Course:** 3 mg/m² on day 1, 2 mg/m² on day 4, and 2 mg/m² on day 7.
* **Subsequent Courses (if needed):** 3 mg/m² on day 1 of each course. A maximum of 4 courses can be given.
## Pediatric Dosing
Dosing for pediatric patients has not been established.
## Dose Adjustments
* **Hepatotoxicity:** If transaminase elevations or hyperbilirubinemia occur, dose reduction or interruption may be necessary. Consult the prescribing information for specific management guidelines.
* **Thrombocytopenia:** Monitor platelet counts closely. Dose may need to be withheld or reduced.
* **Infusion Reactions:** Slow the infusion rate, or temporarily discontinue.
## Contraindications
* Active serious infection.
* Known hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
## Adverse Effects
* **Common:** Febrile neutropenia, thrombocytopenia, nausea, vomiting, diarrhea, stomatitis, headache, pyrexia, rash, fatigue, elevated liver enzymes (AST, ALT, bilirubin).
* **Serious:** Hepatotoxicity (including VOD/SOS), severe infusion reactions, myelosuppression, bleeding events.
## Key Drug Interactions
No significant drug interactions have been definitively identified. However, due to the cytotoxic nature of gemtuzumab ozogamicin, caution may be warranted with other myelosuppressive agents.
## Monitoring
* **Hepatotoxicity:** Monitor liver function tests (bilirubin, AST, ALT) regularly, especially in patients with pre-existing hepatic impairment.
* **Hematologic Parameters:** Complete blood counts with differential and platelet counts should be monitored frequently.
* **Infusion Reactions:** Monitor vital signs during and after infusion.
* **Signs of bleeding and infection.**
## Clinical Pearls
* Mylotarg carries a Black Box Warning for hepatotoxicity, including veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), and bleeding events.
* Administer as a continuous intravenous infusion over 2 hours. Do not administer as a rapid infusion.
* Dosing is based on body surface area (BSA).
* Consider prophylactic treatment for VOD/SOS in patients at high risk, as per institutional guidelines.
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*This information is intended for healthcare professionals. Always consult the most current prescribing information and/or institutional protocols for complete and up-to-date guidance.*
