Nirsevimab: clinical use

Prescribing considerations

• Use according to official recommendations and distinguish the licensed indication from selective NHS eligibility.
• Administration should be by a trained healthcare professional using aseptic technique.
• Safety and efficacy have not been established from age 2 to 18 years.
• Protection may be reduced in some immunocompromised children with protein-losing conditions.
• Record the product name and batch number for biological traceability.

Contraindications and cautions

• Contraindicated in hypersensitivity to nirsevimab or any excipient.
• Use intramuscular injection cautiously in thrombocytopenia or coagulation disorders.
• Polysorbate 80 may cause allergic reactions.

Monitoring

• Be prepared to recognise and manage anaphylaxis or other clinically significant hypersensitivity.
• Check for rash, fever and local injection-site reactions after administration.
• Inspect the solution and syringe before use; do not use cloudy, discoloured, damaged or contaminated-looking products.
• Consider reduced exposure in protein-losing conditions.

Clinical pharmacology

Nirsevimab is a recombinant human IgG1 kappa monoclonal antibody targeting a conserved epitope on prefusion RSV F protein. Its Fc region is modified to prolong persistence. It is degraded by proteolytic catabolism rather than hepatic metabolism or renal excretion.

Formulation and product differences

• The selected presentation contains 50 mg in 0.5 mL in a pre-filled syringe with a purple plunger rod.
• A 100 mg in 1 mL pre-filled syringe with a light-blue plunger rod also exists; verify the carton and syringe label before administration.
• The solution should be clear to opalescent and colourless to yellow. It contains polysorbate 80 and must not be shaken, frozen or mixed with another medicine.

Injection

Route: Parenteral

Strengths: 50 mg, 100 mg