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## Overview
Mylotarg (gemtuzumab ozogamicin) is an antibody-drug conjugate. It consists of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. Gemtuzumab ozogamicin targets CD33, a cell surface antigen expressed on myeloid leukemia cells, delivering the cytotoxic payload directly to these cells.
## Primary Indications
* Treatment of adult patients with newly diagnosed Acute Myeloid Leukemia (AML) who are younger than 60 years old and suitable for intensive chemotherapy.
* Treatment of adult patients with relapsed or refractory AML.
## Adult Dosing
**Newly Diagnosed AML (in combination with intensive chemotherapy):**
* **Induction Cycle 1:** 6 mg/m² on Day 1, Day 4, and Day 7.
* **Induction Cycle 2 (if applicable):** 6 mg/m² on Day 1.
* **Consolidation Therapy:** 6 mg/m² on Day 1 of each consolidation cycle.
**Relapsed or Refractory AML:**
* **First cycle:** 3 mg/m² on Day 1, Day 4, and Day 7.
* **Second cycle (if applicable):** 3 mg/m² on Day 1, Day 4, and Day 7.
*Note: Maximum cumulative dose is 27 mg/m² over the course of treatment.*
## Pediatric Dosing
The safety and efficacy of Mylotarg have not been established in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** If aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal (ULN), or total bilirubin > 2 times ULN, consider withholding or delaying dose. If AST or ALT > 5 times ULN, or total bilirubin > 3 times ULN, consider discontinuing.
* **Myelosuppression:** Dose modifications are typically managed by the treating physician in the context of the entire chemotherapy regimen.
## Contraindications
* None listed in standard prescribing information, but caution is advised in patients with severe hepatic impairment.
## Adverse Effects
* **Common:** Hepatotoxicity (including VOD/SOS), myelosuppression (thrombocytopenia, neutropenia, febrile neutropenia, anemia), nausea, vomiting, diarrhea, mucositis, fatigue, headache, pyrexia, rash.
* **Serious:** Veno-occlusive liver disease/sinusoidal obstruction syndrome (VOD/SOS) is a significant risk, particularly when given with other chemotherapy. Bleeding events, hypersensitivity reactions.
## Key Drug Interactions
* **Hepatotoxic agents:** Concomitant use with other agents known to cause hepatotoxicity may increase the risk of severe liver injury.
* **Myelosuppressive agents:** Concurrent use with other myelosuppressive chemotherapy increases the risk and severity of myelosuppression.
## Monitoring
* **Liver Function Tests (LFTs):** Monitor AST, ALT, and bilirubin regularly, especially before and during treatment cycles.
* **Complete Blood Counts (CBCs):** Monitor for myelosuppression.
* **Signs and Symptoms of VOD/SOS:** Monitor for abdominal pain, ascites, jaundice, and hepatomegaly.
* **Bleeding:** Monitor for signs and symptoms of bleeding.
## Clinical Pearls
* Mylotarg administration requires careful monitoring for hepatotoxicity and myelosuppression.
* The risk of VOD/SOS is increased when gemtuzumab ozogamicin is used in combination with intensive chemotherapy.
* Patients should be well-hydrated during treatment.
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*Disclaimer: This information is intended for clinical pharmacy use and does not replace comprehensive prescribing information. Always consult the most current official prescribing information and relevant clinical guidelines before making any treatment decisions. Dosing and management may vary based on individual patient factors and local protocols.*
