gemtuzumab ozogamicin: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
gemtuzumab ozogamicin: clinical details
Prescribing considerations
- Treatment should be supervised by a clinician experienced in anticancer therapy, with immediate resuscitation facilities available.
- Restrict use to patients eligible for intensive induction chemotherapy with CD33-positive disease.
- Consider cytogenetic risk because benefit is uncertain in adverse-risk cytogenetics.
- Assess hepatic impairment and previous or planned haematopoietic stem-cell transplantation because these may increase VOD/SOS risk.
- Discuss fertility preservation and provide appropriate infusion-reaction premedication and tumour-lysis prevention.
Contraindications and cautions
- Hypersensitivity to gemtuzumab ozogamicin or any excipient.
- Exercise particular caution with clinically significant hepatic dysfunction, previous or planned stem-cell transplantation, active serious infection, bleeding or persistent cytopenias.
Monitoring
- Full blood count and surveillance for cytopenias, infection and bleeding.
- ALT, AST, bilirubin and alkaline phosphatase; clinical signs of VOD/SOS, especially after stem-cell transplantation.
- Pulse, blood pressure, temperature and infusion-reaction symptoms during administration.
- Tumour-lysis risk, hydration, uric acid, renal function and relevant electrolytes.
- Treatment response and cytogenetic findings.
Clinical pharmacology
A humanised IgG4 anti-CD33 antibody is linked to N-acetyl gamma calicheamicin. CD33 binding and internalisation release the cytotoxic component intracellularly, causing double-strand DNA breaks and apoptotic cell death. Calicheamicin derivatives are mainly metabolised by non-enzymatic reduction.
Formulation and product differences
- White to off-white powder for concentrate for intravenous infusion.
- Requires aseptic reconstitution and dilution, an in-line low-protein-binding filter and protection from light.
- Contains no bacteriostatic preservative and is intended for single use.
- Essentially sodium-free before preparation, although sodium-containing diluent may contribute to the total sodium load.
gemtuzumab ozogamicin preparations and strengths
Solution for infusion
Route: Intravenous
Strengths: 5 mg
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.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.