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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).
## Primary Indications
* Relapsed or refractory AML in adult patients.
* Newly diagnosed de novo AML in adult patients, in combination with other agents.
## Adult Dosing
The dosing regimen depends on the specific indication and whether it is used as a single agent or in combination.
**For relapsed or refractory AML as a single agent:**
* Initial dose: 3 mg/m² on Day 1, Day 4, and Day 7.
* Maximum cumulative dose: 9 mg/m².
**For newly diagnosed de novo AML in combination therapy:**
* Dosing is typically integrated into combination chemotherapy regimens, often with daunorubicin and cytarabine. Specific timing and doses per cycle vary. Consult the prescribing information or local protocol for combination regimens.
## Pediatric Dosing
The use of Mylotarg in pediatric patients is not established.
## Dose Adjustments
Dose adjustments are generally not specified within standard protocols but treatment interruption or discontinuation may be necessary based on toxicity.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
## Adverse Effects
* **Hepatotoxicity:** Severe, including hepatic veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS).
* **Cytopenias:** Thrombocytopenia, neutropenia, leukopenia, anemia.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, stomatitis.
* **Hemorrhage:** Especially in patients with severe thrombocytopenia.
* **Infections:** Febrile neutropenia.
## Key Drug Interactions
No significant drug interactions have been definitively established.
## Monitoring
* **Liver Function Tests:** Including bilirubin and transaminases, particularly looking for signs of VOD/SOS.
* **Complete Blood Counts (CBC) with differential:** Monitor for cytopenias and their recovery.
* **Signs and symptoms of infusion-related reactions.**
* **Signs and symptoms of bleeding.**
## Clinical Pearls
* **Hepatotoxicity (VOD/SOS):** This is a serious and potentially fatal toxicity. Patients should be monitored closely. Pre-existing liver disease, prior stem cell transplantation, and higher cumulative doses are risk factors.
* **Infusion Reactions:** Administer premedications as per institutional guidelines. Monitor patients closely during infusion.
* **Hemorrhage:** Monitor platelet counts closely, especially if below 50,000/mm³. Transfusion may be considered.
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*This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional protocols for complete details.*
