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## Mylotarg (gemtuzumab ozogamicin)
### Overview
Mylotarg is an antibody-drug conjugate targeting CD33, a protein found on the surface of myeloid leukemia cells. It is used in the treatment of acute myeloid leukemia (AML).
### Primary Indications
* Newly diagnosed CD33-positive AML in adults in combination with chemotherapy.
* Relapsed or refractory CD33-positive AML in adults.
### Adult Dosing
**Newly Diagnosed AML (in combination with daunorubicin and cytarabine):**
* 6 mg/m² on Day 1, 3, and 5 of induction cycle 1.
* 3 mg/m² on Day 1, 3, and 5 of induction cycle 2 (if achieving remission).
* For consolidation therapy, 3 mg/m² every 4 weeks for up to 12 cycles.
**Relapsed or Refractory AML:**
* First cycle: 3 mg/m² on Day 1, Day 4, and Day 7.
* If tolerated, second cycle: 3 mg/m² on Day 1. If tolerated, subsequent cycles: 3 mg/m² every 2 weeks for up to 8 cycles.
**Maximum dose:** No specific maximum cumulative dose is established, but treatment cycles and duration are per indication.
### Pediatric Dosing
* Safety and efficacy have not been established in pediatric patients.
### Dose Adjustments
* **Hepatotoxicity:** If AST/ALT > 5x ULN or total bilirubin > 2x ULN, consider withholding or dose reduction based on severity and duration.
* **Hyperbilirubinemia:** Dose reduction or temporary discontinuation may be necessary.
* **Thrombocytopenia:** Management depends on the severity and clinical presentation. Dose adjustment may be required.
### Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any component of the formulation.
### Adverse Effects
**Common:**
* Febrile neutropenia, thrombocytopenia, anemia, nausea, vomiting, diarrhea, fatigue, headache, stomatitis, rash, muscle pain, cough, pyrexia, hypokalemia.
**Serious:**
* Hepatotoxicity (including Veno-occlusive disease/Sinusoidal Obstruction Syndrome - VOD/SOS), myelosuppression, hypersensitivity reactions, tumor lysis syndrome, bleeding events.
### Key Drug Interactions
* **Hepatotoxic Agents:** Concomitant use with drugs known to cause hepatotoxicity may increase the risk of liver injury. Careful monitoring is required.
* **Drugs Affecting Platelet Function:** Increased risk of bleeding with anticoagulants (e.g., warfarin, heparin) or antiplatelet agents (e.g., aspirin, clopidogrel).
### Monitoring
* **Complete Blood Counts (CBC) with differential:** Frequent monitoring for myelosuppression, especially during the first few cycles.
* **Liver Function Tests (LFTs):** Monitor bilirubin and transaminases regularly, particularly before and during treatment, due to the risk of hepatotoxicity.
* **Renal Function Tests:** Monitor renal function.
* **Signs and symptoms of bleeding and infection:** Monitor closely due to potential for thrombocytopenia and neutropenia.
* **Signs and symptoms of hypersensitivity reactions.**
### Clinical Pearls
* The risk of VOD/SOS is a significant concern and can be life-threatening. Risk factors include prior stem cell transplant, increasing age, and female sex.
* Monitor patients closely for signs of hepatotoxicity, especially after dose reductions or interruptions.
* Administer prophylactic antiemetics, antidiarrheals, and antipyretics as needed.
* Ensure adequate hydration.
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*This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional protocols for complete details.*
