inotuzumab ozogamicin: clinical use

Prescribing considerations

• Treatment requires supervision by a clinician experienced in cancer therapy, with immediate resuscitation facilities available.
• Confirm CD22 expression using a validated sensitive assay before treatment.
• Assess liver history and planned haematopoietic stem-cell transplantation carefully because VOD/SOS risk may be substantial.
• Consider cytoreduction for circulating lymphoblasts and tumour-lysis prophylaxis for high tumour burden.
• Use recommended corticosteroid, antipyretic and antihistamine premedication.
• Record the product name and batch number for traceability.

Contraindications and cautions

• Hypersensitivity to inotuzumab ozogamicin or an excipient.
• Previous confirmed severe or ongoing VOD/SOS.
• Serious ongoing hepatic disease, including cirrhosis, nodular regenerative hyperplasia or active hepatitis.

Monitoring

• Full blood count and clinical evidence of infection, bleeding and other consequences of myelosuppression.
• ALT, AST, bilirubin and alkaline phosphatase, with intensified monitoring for abnormalities or around HSCT.
• Clinical evidence of VOD/SOS, including painful hepatomegaly, rapid weight gain and ascites.
• Infusion reactions during administration and observation afterwards.
• Tumour lysis syndrome in at-risk patients.
• ECG and electrolytes where QT prolongation is a concern.
• Amylase and lipase periodically.

Clinical pharmacology

A humanised IgG4 CD22-directed monoclonal antibody is covalently linked to a cytotoxic calicheamicin derivative. After CD22 binding and internalisation, intracellular release causes DNA double-strand breaks and apoptotic cell death.

Formulation and product differences

• White to off-white powder for concentrate for intravenous infusion that must be reconstituted and diluted aseptically.
• Single-use, preservative-free and light-sensitive preparation; protect reconstituted and diluted solutions from light and do not freeze.
• Do not mix or co-infuse with other medicinal products.
• The vial contains sucrose, polysorbate 80, sodium chloride and tromethamine. The undiluted product is essentially sodium-free, although diluent may add sodium.

Solution for infusion

Route: Intravenous

Strengths: 1 mg