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# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a monoclonal antibody conjugated to an antineoplastic agent (calicheamicin). It targets the CD33 antigen found on myeloid leukemia cells.
## Primary Indications
* Acute Myeloid Leukemia (AML) in patients who are newly diagnosed and ineligible for intensive induction chemotherapy.
* Relapsed or refractory AML in patients aged 17 years or older.
## Adult Dosing
**Newly Diagnosed AML (ineligible for intensive induction chemotherapy):**
* Day 1: 3 mg/m² intravenously (IV)
* Day 4: 3 mg/m² IV
* Day 7: 2 mg/m² IV
* A second cycle may be administered if there is evidence of bone marrow recovery.
**Relapsed or Refractory AML (aged 17 years or older):**
* Cycle 1: 6 mg/m² IV on Day 1. If there is no evidence of unacceptable toxicity, administer 3 mg/m² IV on Day 4.
* Cycle 2: 3 mg/m² IV on Day 1, Day 4, and Day 7.
**Maximum Dose:** Do not exceed 6 mg/m² in a single administration.
## Pediatric Dosing
The efficacy and safety of Mylotarg have not been established in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** Dose interruption or discontinuation is recommended based on the severity of liver enzyme elevations or bilirubin levels. Consult prescribing information for specific criteria.
* **Cytopenias:** Dose delays may be necessary. Consult prescribing information for specific criteria related to platelet counts and ANC.
* **Infusion Reactions:** Slow infusion rate or interrupt infusion based on severity.
## Contraindications
* None listed in standard prescribing information.
## Adverse Effects
**Most Common:**
* Febrile Neutropenia
* Hepatotoxicity (including veno-occlusive disease/sinusoidal obstruction syndrome)
* Thrombocytopenia
* Nausea, Vomiting
* Mucositis
* Diarrhea
* Fatigue
* Anemia
* Pyrexia
* Headache
* Pneumonia
**Black Box Warnings:**
* **Hepatotoxicity:** Severe, potentially fatal liver toxicity, including VOD/SOS, has occurred in patients treated with Mylotarg, especially those who have undergone hematopoietic stem cell transplantation (HSCT) or have pre-existing liver abnormalities. Monitor liver function tests closely.
* **Myelosuppression:** Mylotarg causes severe myelosuppression, which may lead to infections, bleeding, and anemia. Monitor complete blood counts regularly.
## Key Drug Interactions
No significant drug interactions are listed in standard prescribing information.
## Monitoring
* **Liver Function Tests:** Monitor bilirubin, AST, ALT, and alkaline phosphatase prior to and regularly during treatment. Monitor for signs and symptoms of VOD/SOS.
* **Complete Blood Counts (CBC):** Monitor platelet count, ANC, and hemoglobin prior to and regularly during treatment.
* **Infusion Reactions:** Monitor for signs and symptoms of infusion reactions during and after infusion.
* **Hemostasis:** Monitor coagulation parameters if clinical indication arises.
## Clinical Pearls
* Prehydration and antiemetics are recommended.
* Infusion rate should be adjusted based on patient tolerance.
* The risk of hepatotoxicity is increased in patients with pre-existing liver disease or those who have received HSCT.
* Consider concurrent use of growth factors to manage myelosuppression if indicated.
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*Disclaimer: This information is intended for clinical decision support and does not replace professional medical advice. Always consult the most current prescribing information and local institutional protocols before making any treatment decisions.*
