gemtuzumab ozogamicin at a glance
Medicine class
CD33-directed antibody–drug conjugate and anticancer treatment
Licensed use
Previously untreated, de novo CD33-positive AML, except acute promyelocytic leukaemia
Administration
Slow intravenous infusion given by a specialist hospital team after reconstitution and dilution
Important risks
Low blood-cell counts, serious infection or bleeding, infusion reactions, tumour lysis syndrome and liver injury
What is gemtuzumab ozogamicin used for?
It is licensed for:
Combination therapy with daunorubicin and cytarabine in people aged 15 years and over with previously untreated, de novo CD33-positive AML who are eligible for intensive induction chemotherapy.
It is not licensed for acute promyelocytic leukaemia.
How does gemtuzumab ozogamicin work?
The antibody binds to CD33 on susceptible myeloid leukaemia cells. The complex enters the cell and releases calicheamicin, which causes double-strand DNA breaks, cell-cycle arrest and cell death.
gemtuzumab ozogamicin preparations and strengths
Solution for infusion
Route: Intravenous
Strengths: 5 mg
How to take gemtuzumab ozogamicin
Trained staff prepare and administer it through a vein in a setting with immediate resuscitation facilities. It must not be given as a rapid intravenous injection. A corticosteroid, antihistamine and paracetamol are usually given beforehand to reduce infusion reactions.
Tell the team promptly about symptoms during or shortly after the infusion.
Preparation requires specialist reconstitution, dilution, filtration and protection from light.
It must not be mixed or infused with other medicines through the same preparation.
gemtuzumab ozogamicin side effects
Common or expected effects
- Reduced platelets, white blood cells or red blood cells
- Infections, fever and chills
- Bleeding or easy bruising
- Nausea, vomiting, diarrhoea, abdominal discomfort or constipation
- Reduced appetite, mouth inflammation, headache and fatigue
- Abnormal liver blood tests or raised blood sugar
- Rash, swelling, breathlessness or blood-pressure changes
Get urgent medical advice
- Severe infection or febrile neutropenia
- Serious or persistent bleeding
- Infusion reaction or anaphylaxis
- Hepatic veno-occlusive disease/sinusoidal obstruction syndrome or liver failure
- Tumour lysis syndrome, which can cause kidney injury and abnormal heart rhythms
- Severe, prolonged suppression of blood-cell production
gemtuzumab ozogamicin in pregnancy
Pregnancy should be avoided because human information is limited and animal studies indicate reproductive toxicity. Use during pregnancy is reserved for situations where maternal benefit is judged to outweigh fetal risk. The SmPC advises two effective contraceptive methods during treatment and afterwards—at least 7 months for females and 4 months for males—and immediate specialist contact if pregnancy occurs.
gemtuzumab ozogamicin while breastfeeding
Breastfeeding is not recommended during treatment or for at least 1 month afterwards because transfer into milk is unknown and serious effects in a breastfed child are possible.
gemtuzumab ozogamicin interactions
Clinical interaction studies have not been conducted. The oncology team should review prescribed, non-prescription and herbal products before treatment.
Daunorubicin, cytarabine and hydroxyurea
Population pharmacokinetic analyses did not predict clinically meaningful exposure changes when used with gemtuzumab ozogamicin.
CYP or UGT enzyme inhibitors and inducers
Clinically important effects on calicheamicin exposure are considered unlikely because its main metabolism is non-enzymatic reduction.
Common questions about gemtuzumab ozogamicin
Answers are fully visible for fast scanning and source review.
Why is CD33 testing needed?
The antibody must bind to CD33 to deliver its cytotoxic component into the leukaemia cell, and the licensed indication is specifically CD33-positive AML.
Why are medicines given before the infusion?
A corticosteroid, antihistamine and paracetamol are used to reduce infusion-related symptoms such as fever, chills, rash and breathing problems.
Can it affect stem-cell transplantation?
Previous or subsequent transplantation is associated with a higher VOD/SOS risk, so transplant timing and liver monitoring require specialist review.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.