Gemtuzumab ozogamicin
ADCs
Antibody-drug conjugates (ADCs)High alert
An error with this medicine can cause serious harm: double checks and protocols are used.Pregnancy: avoid
Avoid in pregnancy. It can harm the fetus: a pregnancy test is done first, contraception is used during and for months after treatment by women and men, and breastfeeding is…
An anti-CD33 antibody carrying calicheamicin, a DNA-cutting toxin; used in CD33-positive acute myeloid leukaemia. Watch the liver.
Quick facts
- Group
- Antibody-drug conjugates (ADCs)
- Target
- CD33 (SIGLEC3) on myeloid leukaemia cells
- Key effects
- Fever · Nausea · Headache
- Monitor
- Liver tests · Complete blood count
- ATC
- L01FX02
No doses: the clinician sets them by the current guideline.
Mechanism of action
Gemtuzumab ozogamicin is an antibody-drug conjugate. The antibody binds CD33, found on most myeloid leukaemia blasts. The complex is taken into the cell, where the linker is cleaved and calicheamicin is released. Calicheamicin binds the minor groove of DNA and cuts both strands, killing the cell.
- The antibody binds CD33 on leukaemia blasts
- The cell takes it in and releases calicheamicin
- Calicheamicin cuts both DNA strands and the cell dies
Indications
- Newly diagnosed CD33-positive acute myeloid leukaemia in adults and children from one month of age, alone or with chemotherapy. Acute leukaemia (AML and ALL) →
- Relapsed or refractory CD33-positive acute myeloid leukaemia in adults and children from two years of age. Acute leukaemia (AML and ALL) →
Adverse effects
Common
- Fever, rash
- Nausea, vomiting, constipation, diarrhoea
- Headache, mouth sores
Contraindications
- Hypersensitivity to gemtuzumab ozogamicin
Key interactions
- Daunorubicin and cytarabine (induction chemotherapy)
- Combined in newly diagnosed AML; low blood counts and bleeding are watched closely.
- Drugs that prolong the QT interval, low potassium or magnesium
- Add to QT risk; electrolytes and ECG are checked.
What is monitored
- Liver tests, bilirubin, weight and abdominal girth (veno-occlusive disease)
- Complete blood count
- Vital signs during and after infusion
- Electrolytes and ECG
Administration and safety
- Hazardous drug, prepared and infused intravenously by trained staff as the product instructions describe.
- Premedication is given before each dose to reduce infusion reactions.
- The patient is watched during the infusion and for some hours after.
- Look-alike names: gemtuzumab ozogamicin and inotuzumab ozogamicin are different; the order is checked.
Pregnancy and breastfeeding
Avoid in pregnancy. It can harm the fetus: a pregnancy test is done first, contraception is used during and for months after treatment by women and men, and breastfeeding is stopped.
Nursing care
- Give premedication and monitor vital signs during and after the infusion.
- Weigh daily and teach to report rapid weight gain, right upper abdominal pain or jaundice.
- Teach to report bleeding, fever or breathlessness.
- Contraception for women and men during and after treatment.
Pharmacokinetics
- Absorption
- Intravenous infusion over about two hours, after premedication.
Test yourself
Think of the answer, then tap the question to see it.
Which antigen does gemtuzumab ozogamicin target?
CD33 on myeloid leukaemia blasts.
What is its cytotoxic payload and how does it work?
Calicheamicin, which cuts double-stranded DNA.
What is its boxed warning?
Hepatotoxicity, including hepatic veno-occlusive disease.
Connections
← Back to the class: Antibody-drug conjugates (ADCs)
Educational content on how drugs work; not a prescribing guide and no substitute for a health professional's advice. No doses are given.
Sources: Gemtuzumab Ozogamicin Injection: MedlinePlus Drug Information (MedlinePlus (U.S. National Library of Medicine), 2020); Gemtuzumab Ozogamicin - NCI (National Cancer Institute, 2020); ATCDDD - ATC/DDD Index (WHO Collaborating Centre for Drug Statistics Methodology, 2026).
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Representative model, for educational purposes only.