Please check your internet connection and try again.
# Mylotarg (gemtuzumab ozogamicin)
## Overview
Gemtuzumab ozogamicin is an antibody-drug conjugate that targets CD33, a protein found on most myeloid leukemia cells. It delivers a cytotoxic agent (calicheamicin) directly to cancer cells.
## Primary Indications
* Relapsed or refractory acute myeloid leukemia (AML) in adults.
* Newly diagnosed AML in adults who are 75 years or older or who are unable to tolerate intensive induction chemotherapy.
## Adult Dosing
* **For relapsed/refractory AML:**
* **First cycle:** 3 mg/m² on days 1, 4, and 7.
* **Second cycle (if needed):** 3 mg/m² on days 1, 4, and 7.
* Do not exceed a total of 6 cycles.
* **For newly diagnosed AML (in older adults or those not candidates for intensive chemo):**
* **First cycle:** 6 mg/m² on day 1.
* **Second cycle (if needed):** 3 mg/m² on day 1.
* Further cycles may be administered at 3 mg/m² every 2 to 4 weeks.
## Pediatric Dosing
Mylotarg is not approved for use in pediatric patients.
## Dose Adjustments
* **Hepatotoxicity:** If AST or ALT > 3 times upper limit of normal (ULN) or total bilirubin > 2 times ULN, consider withholding or delaying therapy. Resume when LFTs improve to < 2 times ULN or < 1.5 times ULN, respectively.
* **Thrombocytopenia:** Consider withholding or delaying if platelet count is < 50,000/µL. Resume when platelets recover to > 50,000/µL.
* **Myelosuppression:** Manage with standard supportive care (e.g., transfusions, growth factors).
## Contraindications
* None listed in prescribing information.
## Adverse Effects
* **Most Common:** Febrile neutropenia, nausea, vomiting, diarrhea, stomatitis, headache, fatigue, rash, cough, pyrexia, hypokalemia.
* **Serious:** Hepatotoxicity (especially VOD/SOS), severe myelosuppression (leading to infection, bleeding), hypersensitivity reactions, tumor lysis syndrome.
## Key Drug Interactions
* **Hepatotoxic Agents:** Concomitant use with other drugs known to cause hepatotoxicity may increase the risk of liver injury. Monitor liver function closely.
## Monitoring
* **Hepatotoxicity:** Monitor AST, ALT, and bilirubin at baseline, weekly during treatment, and as clinically indicated. Be vigilant for signs and symptoms of VOD/SOS.
* **Myelosuppression:** Monitor complete blood counts with differential and platelet counts at least weekly.
* **Bleeding:** Monitor for signs and symptoms of bleeding.
* **Infection:** Monitor for signs and symptoms of infection.
## Clinical Pearls
* Veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), is a serious and potentially fatal adverse event. Risk factors include prior stem cell transplant, prior hepatic irradiation, and advanced age.
* Patients should be monitored closely for signs of VOD/SOS, including jaundice, hepatomegaly (especially tender), ascites, weight gain, and splenomegaly.
* If VOD/SOS occurs, treatment should be permanently discontinued.
* Gemtuzumab ozogamicin can cause severe myelosuppression; close monitoring and appropriate supportive care are crucial.
***
*Please verify current prescribing information and local protocols for the most up-to-date and comprehensive guidance.*
