Gemtuzumab Ozogamicin
Gemtuzumab ozogamicin is a targeted therapy combining an anti-CD33 antibody with a cytotoxic agent for treating CD33-positive acute myeloid leukemia by delivering chemotherapy directly to cancer cells.
A CD33-directed antibody-drug conjugate used to treat CD33-positive acute myeloid leukemia in adults and pediatric patients.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01FX02
- RxNorm
- 1294580
- Generic
- Gemtuzumab Ozogamicin
- Class
- atc-l01
- Brands
- Mylotarg
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- solution, injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Treatment of CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients. Commonly used in newly diagnosed and relapsed/refractory cases.
The antibody component binds specifically to CD33 antigen on the surface of AML cells, delivering the cytotoxic calicheamicin payload directly into the cancer cells, causing DNA damage and subsequent cell death.
Requires monitoring for hepatotoxicity, infusion-related reactions, and myelosuppression. Should be administered by healthcare professionals experienced in managing chemotherapy. Important to verify CD33 positivity before treatment.
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy