avelumab: clinical use

Prescribing considerations

• Initiate and supervise treatment within an experienced oncology service.
• Discuss immune-mediated and infusion-related risks, issue the Patient Card and explain that toxicity can occur after treatment ends.
• Assess pre-existing autoimmune disease carefully because immune toxicity and disease flares may be more frequent.
• Review organ transplantation, chronic viral infection, HIV and current immunosuppression.
• With axitinib, follow both products’ toxicity guidance and monitor hepatic effects more frequently.

Contraindications and cautions

• Hypersensitivity to avelumab or any listed excipient.
• Use particular caution where polysorbate hypersensitivity is suspected.

Monitoring

• Record the product name and batch number for traceability.
• Assess for infusion reactions during administration.
• Review symptoms of pulmonary, gastrointestinal, hepatic, cardiac, neurological, muscular, skin and ocular immune toxicity.
• Check liver function, thyroid function, glucose and serum creatinine before and periodically during treatment, with additional tests guided by symptoms.
• Monitor weight and general clinical status.
• Increase liver-function monitoring with axitinib.

Clinical pharmacology

A human IgG1 monoclonal antibody targeting PD-L1. It restores cytotoxic T-cell responses by preventing PD-L1 signalling through PD-1 and B7.1 and may mediate antibody-dependent cellular cytotoxicity. It is cleared mainly through protein-catabolism pathways.

Formulation and product differences

• Clear, colourless to slightly yellow concentrate in a single-use glass vial.
• Requires aseptic dilution in compatible sodium chloride infusion solution and administration through a low-protein-binding filter.
• Do not shake or freeze, or administer other medicines through the same intravenous line.
• Contains mannitol, polysorbate 20, acetic acid, sodium hydroxide and water for injections.

Solution for infusion

Route: Intravenous

Strengths: 20 mg/mL