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RSV Prophylaxis — Monthly Monoclonal Antibody (High-Risk Infants) Pregnancy: Paediatric use only.

Palivizumab

Brand names: Synagis

Adult dose

Dose: Not applicable — paediatric use only
Route: N/A
Frequency: N/A
Max: N/A
Paediatric use only.

Paediatric dose

Dose: 15 mg/kg IM once monthly during RSV season (typically 5 doses: October/November to February/March) mg/kg
Route: Intramuscular
Frequency: Monthly (maximum 5 doses per RSV season)
Max: 15 mg/kg per dose
High-risk infants: premature birth ≤35 weeks GA (under 6 months at start of season), congenital heart disease (haemodynamically significant), chronic lung disease (bronchopulmonary dysplasia — on oxygen or diuretics). MHRA approved from 1992. Note: where nirsevimab is available, palivizumab is being phased out for most indications. Source: BNF for Children 2024; NICE TA284.

Dose adjustments

Renal

No dose adjustment — weight-based dosing.

Hepatic

No dose adjustment required.

Paediatric weight-based calculator

High-risk infants: premature birth ≤35 weeks GA (under 6 months at start of season), congenital heart disease (haemodynamically significant), chronic lung disease (bronchopulmonary dysplasia — on oxygen or diuretics). MHRA approved from 1992. Note: where nirsevimab is available, palivizumab is being phased out for most indications. Source: BNF for Children 2024; NICE TA284.

Clinical pearls

  • IMPACT trial (NEJM 1998): palivizumab reduced RSV hospitalisation by 55% in premature infants (≤35 weeks GA) and by 45% in infants with BPD vs placebo — established the monthly injection programme. Considered standard of care for high-risk infants for 25+ years.
  • Being superseded by nirsevimab: in healthcare systems where nirsevimab is available, palivizumab is now reserved for extreme cases where nirsevimab is not tolerated or available, or where a second dose of RSV prophylaxis is required in the same season (palivizumab can be re-dosed monthly, nirsevimab is not currently approved for repeat dosing within a season).
  • Haemodynamically significant CHD: palivizumab was the first drug licensed for RSV prophylaxis in CHD infants (post-CARDIAC trial). In complex CHD with pulmonary hypertension or cyanotic disease, RSV can cause life-threatening LRTIs. Palivizumab/nirsevimab reduces hospitalisation and ICU admissions.
  • Monthly scheduling challenge: five monthly IM injections requires coordinated hospital/community outreach visits — logistical burden on families, particularly if infant is otherwise well but premature. Nirsevimab's single-dose advantage is therefore clinically and programmatically significant.
  • Cost-effectiveness: palivizumab is expensive at £600–800 per injection (×5 = £3,000–4,000 per season). Nirsevimab at single-dose cost is more cost-effective for population-level use. NICE TA284 recommends palivizumab only for defined high-risk groups (TA284 still in effect for settings without nirsevimab). Source: BNF for Children 2024; Feltes et al. J Pediatr 2003; NICE TA284; MHRA SPC Synagis.

Contraindications

  • Hypersensitivity to palivizumab or humanised monoclonal antibodies
  • Active RSV infection (prophylaxis, not treatment)

Side effects

  • Fever, injection site reactions (most common)
  • Rhinitis, rash
  • Otitis media (may occur despite prophylaxis — RSV prophylaxis does not prevent all viral LRTI)

Interactions

  • Live vaccines: no interaction — palivizumab is a passive immunisation agent and does not interfere with active vaccination immune responses
  • Nirsevimab: do not co-administer

Monitoring

  • Observe for 30 minutes post-injection (anaphylaxis)
  • Weight monthly (dose recalculation at each visit)
  • RSV PCR if LRTI develops (confirm RSV despite prophylaxis — document for surveillance)

Reference: BNF for Children 2024; Simoes et al. NEJM 1998 (IMPACT trial); NICE TA284; MHRA SPC Synagis. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.