Please check your internet connection and try again.
# Mylotarg (gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin is an antibody-drug conjugate that targets CD33, a protein expressed on the surface of acute myeloid leukemia (AML) cells. It delivers a cytotoxic agent, calicheamicin, directly to CD33-positive cells, leading to cell death.
## Primary Indications
* Treatment of newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults.
* Treatment of relapsed or refractory CD33-positive AML in adults.
## Adult Dosing
* **Newly Diagnosed AML:**
* **First Cycle:** 3 mg/m² on days 1, 4, and 7.
* **Second Cycle (if achieving CR/CRi):** 3 mg/m² on days 1, 4, and 7.
* **Maximum dose per infusion:** 4.8 mg.
* **Relapsed or Refractory AML:**
* **First Cycle:** 3 mg/m² on day 1.
* **Second Cycle (if achieving CR/CRi):** 3 mg/m² on day 1.
* **Third Cycle (if achieving CR/CRi and no significant toxicity):** 3 mg/m² on day 1.
* **Maximum dose per infusion:** 4.8 mg.
Dosing regimens may vary based on local protocols and patient-specific factors.
## Pediatric Dosing
The efficacy and safety of gemtuzumab ozogamicin have not been established in pediatric patients.
## Dose Adjustments
* **Hepatic Impairment:** No specific dose adjustment is recommended. However, gemtuzumab ozogamicin is contraindicated in patients with severe hepatic impairment. Monitor liver function closely.
* **Renal Impairment:** No specific dose adjustment is recommended. Monitor renal function closely.
## Contraindications
* Hypersensitivity to gemtuzumab ozogamicin or any of its components.
* Severe hepatic impairment.
## Adverse Effects
* **Hepatotoxicity:** Including veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS), characterized by jaundice, hepatomegaly, ascites, and coagulopathy. This is a serious and potentially fatal adverse event.
* **Myelosuppression:** Including neutropenia, thrombocytopenia, anemia, and febrile neutropenia.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, mucositis.
* **Bleeding events.**
* **Infections.**
## Key Drug Interactions
* **Hepatotoxic agents:** Concomitant use with other drugs known to cause hepatotoxicity may increase the risk of liver injury. Closely monitor liver function.
## Monitoring
* **Liver function tests (LFTs):** Before starting treatment, regularly during treatment, and as clinically indicated. Monitor closely for signs and symptoms of VOD/SOS.
* **Complete blood counts (CBC) with differential:** Before starting treatment, regularly during treatment, and as clinically indicated. Monitor for myelosuppression.
* **Signs and symptoms of infusion-related reactions.**
* **Signs and symptoms of bleeding.**
* **Signs and symptoms of infection.**
## Clinical Pearls
* VOD/SOS is a serious risk; early recognition and management are critical. Signs include hyperbilirubinemia, right upper quadrant pain, hepatomegaly, ascites, and thrombocytopenia.
* Administer premedication (e.g., acetaminophen, antihistamines, corticosteroids) to reduce the risk of infusion-related reactions.
* Monitor patients closely for signs of myelosuppression and infection.
**Disclaimer:** This information is intended for healthcare professionals. Always consult the most current prescribing information and relevant clinical guidelines for complete and up-to-date information before making any treatment decisions.
