amivantamab: clinical use

Prescribing considerations

• Confirm the qualifying EGFR mutation using a validated tissue or plasma test; consider tissue testing after a negative plasma result where suitable tissue is available.
• Initiate and supervise treatment through an experienced oncology service with facilities for managing administration-related reactions.
• Provide indicated premedication and implement proactive skin and nail care.
• When combined with lazertinib, assess thrombosis risk and arrange appropriate prophylaxis; vitamin K antagonists are not recommended for this purpose.
• Record the product name and batch number to maintain biological-medicine traceability.

Contraindications and cautions

• Hypersensitivity to amivantamab or any formulation excipient.
• Use caution in severe renal impairment and moderate or severe hepatic impairment because clinical experience is limited.
• Investigate suspected interstitial lung disease promptly and permanently discontinue if confirmed.
• Promptly assess severe skin reactions or worsening eye symptoms; stop contact-lens use pending eye assessment.

Monitoring

• Administration-related symptoms during and after treatment
• New respiratory symptoms suggesting interstitial lung disease
• Skin, nail and ocular toxicity
• Signs and symptoms of venous thromboembolism when used with lazertinib
• Albumin, electrolytes, liver tests and other laboratory parameters appropriate to the combination regimen

Clinical pharmacology

A low-fucose, fully human IgG1 bispecific antibody binding extracellular EGFR and MET. It inhibits receptor signalling, promotes receptor degradation and supports immune-effector destruction of tumour cells. Conventional hepatic enzyme metabolism and renal excretion are not expected to be major elimination pathways.

Formulation and product differences

• The subcutaneous formulation is ready to use, contains recombinant human hyaluronidase and is administered into abdominal tissue.
• The intravenous formulation is a concentrate requiring dilution, in-line filtration and controlled infusion.
• Administration-related reactions are more frequent with the intravenous formulation; local injection-site reactions can occur with subcutaneous use.

Solution for infusion

Route: Intravenous

Strengths: 350 mg

Injection

Route: Parenteral

Strengths: 1600 mg, 2240 mg