Please check your internet connection and try again.
# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is an antibody-drug conjugate (ADC) consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It targets CD33-expressing cells, primarily in acute myeloid leukemia (AML).
## Primary Indications
* Treatment of newly diagnosed adult patients with Acute Myeloid Leukemia (AML) who are less than 75 years of age, in combination with daunorubicin and cytarabine.
* Treatment of adult patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are less than 75 years of age.
## Adult Dosing
**For newly diagnosed AML (in combination with daunorubicin and cytarabine):**
* Day 1: 3 mg/m² intravenously (IV) over 2 hours.
* Day 4: 3 mg/m² IV over 2 hours.
* Day 7: 2 mg/m² IV over 2 hours.
**For relapsed or refractory AML:**
* 3 mg/m² IV over 2 hours on Day 1. If there is no evidence of unacceptable toxicity, a second course may be administered on Day 4 (3 mg/m² IV over 2 hours) and a third course on Day 7 (2 mg/m² IV over 2 hours). Doses should be separated by at least 14 days.
## Pediatric Dosing
The safety and efficacy 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 increase. Consult the prescribing information for specific management guidelines.
* **Thrombocytopenia:** Mylotarg can cause or exacerbate thrombocytopenia. Monitoring of platelet counts is essential.
## Contraindications
* None explicitly listed in standard prescribing information, but caution is advised in patients with severe hepatic impairment.
## Adverse Effects
* **Most Common:** Fever, nausea, vomiting, diarrhea, stomatitis, headache, pyrexia, constipation, rash, fatigue, increased transaminases, increased bilirubin, increased alkaline phosphatase, thrombocytopenia, neutropenia, anemia.
* **Serious:** Hepatotoxicity (including VOD/SOS), myelosuppression (including prolonged neutropenia and thrombocytopenia), hypersensitivity reactions, tumor lysis syndrome, embryo-fetal toxicity.
## Key Drug Interactions
* No significant drug interactions are listed. However, concurrent use with other myelosuppressive agents may increase the risk of myelosuppression.
## Monitoring
* **Before and during treatment:** Complete blood counts (CBC) with differential and platelet counts, liver function tests (LFTs) including bilirubin, AST, ALT, and alkaline phosphatase, coagulation parameters (PT/INR, PTT).
* **Regularly:** Monitor for signs and symptoms of hepatotoxicity, hypersensitivity reactions, and tumor lysis syndrome.
## Clinical Pearls
* Administer Mylotarg over 2 hours to reduce the risk of infusion-related reactions.
* Consider prophylactic treatment for tumor lysis syndrome, especially in patients with a high tumor burden.
* Hepatotoxicity, particularly veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), is a significant risk and can be severe. Early recognition and management are critical.
* Ensure adequate contraception for both males and females of reproductive potential during and for a period after treatment.
***
*Disclaimer: This information is intended for healthcare professionals and is not a substitute for professional medical advice. Always verify the current prescribing information and consult with appropriate resources before making clinical decisions.*
