About gemtuzumab ozogamicin
CD33-targeted antibody-drug conjugate
Used for
- Treats newly diagnosed CD33-positive acute myeloid leukemia (AML), with chemotherapy.
- Treats relapsed or refractory CD33-positive AML in adults and children.
Usual adult dose
Newly diagnosed AML: commonly 3 mg/m² intravenously on days 1, 4, and 7 with chemotherapy. Relapsed or refractory AML: commonly 3 mg/m² on days 1, 4, and 7, or 6 mg/m² on day 1 and 3 mg/m² on day 8.
Usual dose in children
For children aged 1 month and older with relapsed or refractory AML, dosing is based on body-surface area and treatment regimen; specialist protocols vary.
Common side effects
- Low blood cell counts and serious infections
- Bleeding
- Liver injury, including veno-occlusive disease
- Infusion reactions, fever, nausea, or vomiting
Important warnings
- Can cause severe or fatal liver injury, including veno-occlusive disease.
- May cause serious infections and bleeding due to low blood counts.
- Infusion reactions can be severe; monitoring during and after infusion is required.
- Can harm an unborn baby; blood counts and liver function require monitoring.
Pregnancy
May cause fetal harm. Pregnancy testing and effective contraception during treatment and for at least six months afterward are recommended.
Breastfeeding
Breastfeeding is not recommended during treatment or for at least one month after the final dose.
Interactions
- Other medicines that cause liver injury may increase liver-related risks.
- Other medicines that suppress bone marrow may worsen low blood counts.
AI-generated from general medical knowledge, not from this product's official leaflet. It may be incomplete or out of date. Not medical advice — ask a pharmacist or doctor before making any decision.