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# Gemtuzumab Ozogamicin (Mylotarg)
## Overview
Gemtuzumab ozogamicin is a humanized anti-CD33 monoclonal antibody conjugated to an antitumor antibiotic, calicheamicin. It is indicated for the treatment of certain types of acute myeloid leukemia (AML).
## Primary Indications
* Newly diagnosed CD33-positive AML in adult patients in combination with chemotherapy.
* Relapsed or refractory CD33-positive AML in adult patients.
## Adult Dosing
* **For newly diagnosed AML (in combination with chemotherapy):**
* 9 mg/m² on days 4, 7, and 10 of the first course of chemotherapy, and on days 5 and 8 of the second course of chemotherapy.
* Maximum single dose: 9 mg/m².
* **For relapsed or refractory AML:**
* First course: 6 mg/m² on days 1, 4, 7, and 10, OR 3 mg/m² on days 1, 4, 7, and 10.
* Second course (if eligible): 3 mg/m² on days 1, 4, 7, and 10.
* Maximum dose for a single administration is 3 mg/m² or 6 mg/m² depending on the treatment regimen.
## Pediatric Dosing
Dosing in pediatric patients is not well established and should be determined by a specialist based on weight and clinical judgment.
## Dose Adjustments
* **Hepatic Impairment:** Use with caution. If bilirubin is >2.5 times ULN, consider withholding or reducing the dose.
* **Hematologic Toxicity:** Dose interruption or delay may be necessary based on the severity of myelosuppression. Specific guidance is dependent on the treatment regimen and local protocols.
## Contraindications
* Known hypersensitivity to gemtuzumab ozogamicin or any of its components.
## Adverse Effects
Common adverse effects include:
* Myelosuppression (neutropenia, thrombocytopenia, anemia)
* Febrile neutropenia
* Nausea, vomiting, diarrhea
* Mucositis, stomatitis
* Fatigue, fever, headache
* Hepatotoxicity (e.g., veno-occlusive disease/sinusoidal obstruction syndrome, elevated transaminases)
* Hemorrhage
## Key Drug Interactions
* **Potent CYP3A4 Inhibitors/Inducers:** Gemtuzumab ozogamicin is not a substrate, inhibitor, or inducer of major CYP enzymes. However, concomitant use with other chemotherapy agents or drugs affecting bone marrow function may increase the risk of myelosuppression.
## Monitoring
* Complete blood counts (CBC) with differential and platelet count regularly.
* Liver function tests (LFTs), including bilirubin and transaminases, before and during treatment.
* Signs and symptoms of bleeding, infection, and infusion reactions.
* Signs and symptoms of veno-occlusive disease/sinusoidal obstruction syndrome.
## Clinical Pearls
* Administer as an intravenous infusion.
* Premedication with an antihistamine, corticosteroid, and antipyretic may be considered to reduce infusion-related reactions.
* Monitor closely for signs of hepatotoxicity, particularly veno-occlusive disease/sinusoidal obstruction syndrome, which can be severe and potentially fatal.
* The risk of myelosuppression is significant; patients should be closely monitored for infection and bleeding.
***
*This information is intended for healthcare professionals. Always consult the most current prescribing information and institutional protocols for complete details and to ensure patient safety.*
