dinutuximab beta: clinical use

Prescribing considerations

• Restrict use to specialist oncology care with immediate access to full resuscitation facilities.
• Confirm adequate oxygenation and marrow, hepatic and renal function; uncontrolled systemic infection should be absent.
• Plan multimodal analgesia and antihistamine premedication, with emergency anaphylaxis treatment available.
• Evidence is limited in renal or hepatic impairment and absent in children younger than 12 months.
• Interleukin-2 co-administration increases several toxicities.

Contraindications and cautions

• Hypersensitivity to dinutuximab beta or any excipient.
• Acute grade 3 or 4 graft-versus-host disease.
• Extensive chronic graft-versus-host disease.
• Pregnancy and use in women of childbearing potential who are not using contraception.

Monitoring

• Record the product name and batch number.
• Monitor blood pressure, pulse, oxygenation and respiratory status closely.
• Check full blood count, renal function, liver function and electrolytes regularly.
• Assess pain, neurological symptoms, peripheral motor and sensory function, and visual changes.
• Monitor for capillary leak syndrome, systemic infection and atypical haemolytic uraemic syndrome.
• Interrupt or discontinue treatment according to toxicity severity and persistence.

Clinical pharmacology

A mouse-human chimeric IgG1 monoclonal antibody against GD2. It triggers antibody-dependent cell-mediated and complement-dependent cytotoxicity and is expected to undergo proteolysis into peptides and amino acids.

Formulation and product differences

• Colourless to slightly yellow concentrate for intravenous infusion in a single-use vial.
• Requires aseptic dilution with sodium chloride infusion containing human albumin.
• Use a separate infusion line for other intravenous medicines. An in-line filter is recommended; elastomeric pumps are not considered suitable with in-line filters.
• Store unopened vials refrigerated and protected from light.