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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a CD33-directed antibody and DNA-binding intercalating agent for the treatment of acute myeloid leukemia (AML).
## Primary Indications
* Treatment of adult patients with newly diagnosed AML who are ineligible for intensive induction chemotherapy.
* Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
The total dose administered over the first cycle should not exceed 6 mg/kg.
**For newly diagnosed AML patients ineligible for intensive induction chemotherapy:**
* **Treatment Schedule:** 6 mg/kg on Day 1, 3 mg/kg on Day 4, and 3 mg/kg on Day 7.
* **Subsequent Cycles:** For patients achieving a complete remission (CR) or CR with incomplete hematologic recovery (CRi), up to 3 additional cycles may be administered at 3 mg/kg every 4 weeks.
**For relapsed or refractory AML patients:**
* **Treatment Schedule:** 6 mg/kg on Day 1 and 3 mg/kg on Day 4.
* **Subsequent Cycles:** For patients achieving a CR or CRi, up to 3 additional cycles may be administered at 3 mg/kg every 4 weeks.
## Pediatric Dosing
The safety and efficacy of Mylotarg in pediatric patients (birth to $<17$ years) have not been established.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation may be necessary based on the severity of hepatotoxicity.
* **Thrombocytopenia:** Dose interruption or discontinuation may be necessary based on the severity of thrombocytopenia.
* **Posterior Reversible Encephalopathy Syndrome (PRES):** Discontinue Mylotarg immediately.
## Contraindications
* None listed.
## Adverse Effects
* **Hepatotoxicity:** Hepatic sinusoidal obstruction syndrome (SOS), also known as veno-occlusive disease (VOD), has occurred, potentially fatal. Risk factors include prior stem cell transplant, prior or concurrent chemotherapy, and pre-existing liver disease.
* **Hematologic Toxicity:** Severe thrombocytopenia, neutropenia, and febrile neutropenia.
* **Bleeding Events:** Hemorrhage, including fatal cases. Risk increases with severe thrombocytopenia.
* **Infusion-Related Reactions:** Fever, chills, rash, and dyspnea.
* **Embryo-Fetal Toxicity:** Mylotarg can cause fetal harm. Advise females of reproductive potential to use effective contraception.
## Key Drug Interactions
* No significant drug interactions have been identified.
## Monitoring
* **Hepatotoxicity:** Monitor liver function tests (ALT, AST, bilirubin, alkaline phosphatase) regularly.
* **Hematologic:** Monitor complete blood counts frequently.
* **Bleeding:** Monitor for signs and symptoms of bleeding.
* **Pregnancy Testing:** Perform pregnancy testing for females of reproductive potential.
## Clinical Pearls
* Mylotarg is administered as an intravenous infusion. The infusion rate should be slowed or stopped if infusion-related reactions occur.
* Consider prophylactic use of granulocyte colony-stimulating factors (G-CSF) to reduce the risk of febrile neutropenia.
* Due to the risk of hepatotoxicity, particularly SOS/VOD, careful monitoring and patient selection are crucial.
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*This information is intended for healthcare professionals. Always consult the official prescribing information and relevant guidelines for the most up-to-date and complete details before prescribing or administering Mylotarg.*
