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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a CD33-directed antibody-drug conjugate used in the treatment of acute myeloid leukemia (AML). It targets CD33-expressing cancer cells.
## Primary Indications
* Treatment of newly diagnosed adult patients with CD33-positive AML in combination with induction and consolidation chemotherapy.
* Treatment of adult patients with relapsed or refractory CD33-positive AML.
## Adult Dosing
* **Newly Diagnosed CD33-positive AML (in combination):**
* **Induction:** 3 mg/m² administered on days 1, 4, and 7.
* **Consolidation:** 3 mg/m² administered on day 1 of each cycle for up to 4 cycles.
* **Relapsed or Refractory CD33-positive AML:**
* 6 mg/m² administered on day 1.
* If not achieving remission and not experiencing unacceptable toxicity, a second dose of 3 mg/m² can be administered on day 4.
* Maximum of 2 doses per patient.
## Pediatric Dosing
Mylotarg is not recommended for pediatric patients. Efficacy and safety have not been established.
## Dose Adjustments
* **Hepatic Impairment:** No dose adjustment recommended. However, caution is advised due to potential for increased exposure.
* **Renal Impairment:** No dose adjustment recommended. However, caution is advised.
## Contraindications
* Hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
## Adverse Effects
Common adverse effects include:
* Hepatotoxicity (including sinusoidal obstruction syndrome/veno-occlusive disease)
* Myelosuppression (thrombocytopenia, neutropenia, leukopenia, anemia)
* Infusion-related reactions
* Nausea, vomiting, diarrhea
* Fever
* Headache
* Bleeding events
* Edema
## Key Drug Interactions
No specific drug interaction studies have been conducted. Monitor for potential additive myelosuppression with other myelosuppressive agents.
## Monitoring
* **Before and during treatment:** Complete blood counts (CBC) with differential and platelet count.
* **Liver function tests:** Monitor bilirubin, ALT, AST, and alkaline phosphatase.
* **Signs and symptoms of infusion-related reactions.**
* **Signs and symptoms of bleeding and infection.**
* **Signs and symptoms of hepatotoxicity/sinusoidal obstruction syndrome (SOS).**
## Clinical Pearls
* Administer prophylactic antiemetics, antidiarrheals, and antipyretics.
* Premedication with corticosteroids and antihistamines may reduce infusion-related reactions.
* Monitor closely for signs of SOS/VOD, which can be severe and potentially fatal.
* Discontinue Mylotarg if severe infusion reactions or SOS/VOD occur.
* Dosing and treatment cycles may vary based on specific institutional protocols and patient response. It is crucial to consult the most current local guidelines.
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*Disclaimer: This information is intended for healthcare professionals and is a summary. Always consult the official prescribing information and current clinical guidelines for the most accurate and complete dosing, safety, and management details before prescribing or administering any medication.*
