Please check your internet connection and try again.
# Mylotarg (gemtuzumab ozogamicin)
## Overview
Mylotarg is a targeted therapy, an antibody-drug conjugate consisting of a humanized anti-CD33 monoclonal antibody linked to the cytotoxic agent calicheamicin. It targets CD33-expressing cells, primarily leukemic blasts.
## Primary Indications
* Newly diagnosed acute myeloid leukemia (AML) in adult patients who are ineligible for intensive induction chemotherapy.
* Relapsed or refractory AML in adult patients.
## Adult Dosing
* **Newly diagnosed AML (in combination with chemotherapy):**
* First course: 3 mg/m² on days 1, 4, and 7.
* Second course (if responding and medically fit): 3 mg/m² on days 1, 4, and 7.
* **Relapsed or refractory AML:**
* 3 mg/m² on days 1, 4, and 7.
* If hematologic and organ function criteria are met, a second course of 3 mg/m² on days 1, 4, and 7 can be given.
## Pediatric Dosing
The safety and efficacy of Mylotarg have not been established in pediatric patients.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. Dosing adjustments may be necessary based on bilirubin levels.
* Bilirubin 1.5-3 mg/dL: Consider reducing the dose by 50%.
* Bilirubin >3 mg/dL: Avoid use.
* **Myelosuppression:** Dose delays or reductions may be required if severe myelosuppression occurs. Consult prescribing information for specific guidance.
## Contraindications
* None specifically listed, but caution is advised in patients with severe hepatic impairment.
## Adverse Effects
* **Hepatotoxicity:** Including veno-occlusive liver disease (VOD), also known as sinusoidal obstruction syndrome (SOS). This is a serious and potentially fatal adverse effect.
* **Myelosuppression:** Neutropenia, thrombocytopenia, anemia, febrile neutropenia.
* **Bleeding/Hemorrhage:** Particularly when combined with myelosuppressive chemotherapy.
* **Infusion-related reactions:** Fever, chills, rash, dyspnea.
* **Gastrointestinal:** Nausea, vomiting, diarrhea, stomatitis.
* **Increased liver enzymes.**
## Key Drug Interactions
* **Concomitant chemotherapy:** Mylotarg is often used with chemotherapy. Co-administration increases the risk of myelosuppression and bleeding. Close monitoring is essential.
* **Drugs affecting liver function:** Use with caution.
## Monitoring
* **Liver function tests (LFTs):** Including bilirubin and AST/ALT, before each dose and regularly during treatment.
* **Complete blood counts (CBCs):** Including differential and platelet counts, frequently to monitor for myelosuppression.
* **Signs and symptoms of VOD/SOS:** Monitor for jaundice, hepatomegaly, ascites, and weight gain.
* **Signs and symptoms of bleeding.**
* **Infusion-related reactions.**
## Clinical Pearls
* Mylotarg carries a Black Box Warning for hepatotoxicity, including VOD/SOS, and for fatal hemorrhage, particularly when used with standard induction chemotherapy.
* Hepatotoxicity can occur during treatment or after discontinuation.
* Monitor patients very closely for signs of liver toxicity, especially VOD/SOS, and bleeding.
* Consider dose modifications or discontinuation based on toxicity.
* Ensure adequate hydration and supportive care for management of adverse effects.
***
*This information is intended for healthcare professionals. Please consult the official prescribing information for Mylotarg for complete details, including boxed warnings, contraindications, precautions, drug interactions, and adverse reactions. Dosing may vary based on individual patient factors and local protocols. Always verify current prescribing information before use.*
