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RSV Prophylaxis — Long-Acting Monoclonal Antibody

Nirsevimab

Brand names: Beyfortus

Nirsevimab is a long-acting recombinant monoclonal antibody given for passive immunisation against respiratory syncytial virus (RSV) lower respiratory tract disease in infants.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It is a humanised IgG1 monoclonal antibody that binds a conserved epitope on the prefusion form of the RSV fusion (F) protein, neutralising the virus and preventing fusion with and entry into host cells.

Prescribing in practice

  • As with any biological agent, serious hypersensitivity including anaphylaxis is possible, so administer where reactions can be managed and avoid in known hypersensitivity to the product.
  • It provides passive immunity for an RSV season as a single intramuscular dose, rather than active vaccination, so it confers no lasting immunological memory.
  • Administer in line with the SPC and national immunisation guidance for the relevant infant cohorts.

Monitoring

Observe for immediate injection-site and hypersensitivity reactions after administration; no routine laboratory monitoring is required.

Counselling the patient

  • Explain that this single injection helps protect the baby against severe RSV chest infection for the RSV season.
  • It is given as a passive antibody and is not a routine childhood vaccine.
  • Report any rash, swelling, breathing difficulty or signs of an allergic reaction after the injection.

Evidence & guidelines

Randomised trials (including the MELODY and HARMONIE studies) demonstrated that nirsevimab reduces medically attended and hospitalised RSV lower respiratory tract infection in infants, supporting its adoption in national RSV programmes.

Reference: Hammitt et al. NEJM 2022 (MELODY trial); NICE TA885; MHRA SPC Beyfortus; JCVI RSV immunisation programme 2024; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.