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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a humanized monoclonal antibody conjugated to a cytotoxic agent, calicheamicin. It targets the CD33 antigen, which is expressed on myeloid leukemia cells.
## Primary Indications
* Acute Myeloid Leukemia (AML) in patients who are newly diagnosed or have relapsed/refractory disease.
## Adult Dosing
**Newly Diagnosed AML:**
* **First cycle:** 3 mg/m² on day 1, 2 mg/m² on day 4, and 2 mg/m² on day 7.
* **Subsequent cycles (if needed):** 3 mg/m² on day 1. A maximum of 4 cycles is recommended.
**Relapsed/Refractory AML:**
* **First course:** 3 mg/m² on day 1.
* **Second course (if needed):** 3 mg/m² on day 1.
* A maximum of 2 courses is recommended.
## Pediatric Dosing
Safety and efficacy have not been established in pediatric patients. Consult current institutional protocols or specialized pediatric oncology resources.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary. Refer to specific guidelines for managing veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) and elevated transaminases.
* **Myelosuppression:** Dose interruption or delay may be required.
## Contraindications
* None listed. However, caution is advised in patients with severe hepatic impairment or pre-existing VOD/SOS.
## Adverse Effects
* **Common:** Nausea, vomiting, diarrhea, mucositis, stomatitis, fever, headache, rash, elevated liver enzymes, neutropenia, thrombocytopenia, anemia.
* **Serious:** Veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS), particularly in patients receiving other hepatotoxic agents or undergoing stem cell transplantation; severe myelosuppression; tumor lysis syndrome; hypersensitivity reactions.
## Key Drug Interactions
* **Hepatotoxic agents:** Increased risk of liver toxicity when used concurrently with other drugs known to cause liver injury, especially in the context of stem cell transplantation.
## Monitoring
* Complete blood counts (CBC) with differential and platelet count: Before each dose and regularly thereafter.
* Liver function tests (LFTs): Before each dose and regularly thereafter.
* Signs and symptoms of VOD/SOS and hypersensitivity reactions.
## Clinical Pearls
* Risk of VOD/SOS is increased in patients receiving gemtuzumab ozogamicin in combination with other chemotherapy or undergoing stem cell transplantation.
* Early recognition and management of VOD/SOS are critical.
* Dosing is based on actual body surface area (BSA).
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*This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional guidelines before making any treatment decisions. This summary does not encompass all possible information and may not reflect the latest updates.*
