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## Mylotarg (gemtuzumab ozogamicin)
### Overview
Mylotarg is an antibody-drug conjugate that targets CD33, a protein found on the surface of myeloid leukemia cells.
### Primary Indications
* Treatment of newly diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years of age or older, or who have comorbidities that preclude intensive induction chemotherapy.
* Treatment of relapsed or refractory CD33-positive AML in adult patients.
### Adult Dosing
The dosing regimen for Mylotarg can vary based on the indication and whether it's used in combination with other therapies. It is typically administered intravenously.
**For newly diagnosed AML in older adults:**
* **First cycle:** 3 mg/m² on Day 1, 2 mg/m² on Day 4, and 2 mg/m² on Day 7.
* **Second cycle (if needed):** 3 mg/m² once every 1 to 2 weeks.
**For relapsed or refractory 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, up to 4 total cycles):** 3 mg/m² once every 1 to 2 weeks.
**Maximum cumulative dose:** 22.8 mg/m² over the course of treatment.
**Preparation:** Mylotarg is reconstituted and further diluted before intravenous infusion. Infusion rates and duration are specified in the prescribing information.
### Pediatric Dosing
Established pediatric dosing for Mylotarg is **not available**. Its use in pediatric patients has not been studied.
### Dose Adjustments
Dose adjustments may be necessary based on toxicity. Refer to the prescribing information for specific guidance on managing adverse events, including hematologic toxicity, hepatotoxicity, and infusion-related reactions.
### Contraindications
* Hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
### Adverse Effects
* **Hepatotoxicity:** Including veno-occlusive liver disease (VOD)/sinusoidal obstruction syndrome (SOS), hyperbilirubinemia, and elevated transaminases. This is a serious and potentially life-threatening adverse event.
* **Hematologic Toxicity:** Including thrombocytopenia, neutropenia, and anemia.
* **Infusion-Related Reactions:** Including fever, chills, rash, and dyspnea.
* **Bleeding:** Increased risk, particularly in patients with severe thrombocytopenia.
* **Infections:** Increased risk due to neutropenia.
* **Nausea, vomiting, diarrhea, stomatitis.**
### Key Drug Interactions
* **Strong CYP3A4 Inhibitors:** May increase exposure to nedacdribine, the active metabolite of calicheamicin (a component of gemtuzumab ozogamicin).
* **Live Vaccines:** Avoid concurrent use due to immunosuppression.
### Monitoring
* **Liver Function Tests:** Monitor bilirubin, AST, ALT, and alkaline phosphatase regularly, especially before and during treatment. Monitor for signs and symptoms of VOD/SOS.
* **Complete Blood Counts (CBC) with differential:** Monitor regularly for cytopenias.
* **Infusion-Related Reactions:** Monitor vital signs and observe patients during and after infusion.
* **Signs of Bleeding and Infection.**
### Clinical Pearls
* Mylotarg is associated with a significant risk of hepatotoxicity, particularly VOD/SOS. Early recognition and management are crucial.
* Patients with baseline liver dysfunction may be at increased risk.
* Close monitoring of hematologic parameters is essential due to the risk of myelosuppression.
* Consider prophylactic measures for infection and bleeding based on patient risk factors and laboratory values.
**Disclaimer:** This information is intended for clinical pharmacists and healthcare professionals. It is crucial to consult the most current prescribing information and relevant guidelines for complete details and to verify dosages and safety information before administration, as protocols and recommendations may evolve.
