Nirsevimab
BEYFORTUS
What it isLong-acting anti-RSV antibody; passive immunization of infants.
Why this oneA single dose covers an entire RSV season.
What limits itHypersensitivity and injection-site reactions can occur; it prevents RSV disease but does not treat an active infection.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Prevention of RSV lower respiratory tract disease — first RSV season | Neonates and infants | 50 mg IM if <5 kg; 100 mg IM if ≥5 kg | single IM dose | 100 mg (single dose) |
| Prevention of RSV lower respiratory tract disease — second RSV season (children who remain at increased risk) | Children up to 24 months | 200 mg IM (2 × 100 mg) | single dosing | 200 mg |
Renal Undefined
Hepatic Undefined
Additional dose recommended after cardiac surgery with cardiopulmonary bypass once the child is stable
Instructions
- Administer as an intramuscular injection, preferably in the anterolateral thigh (avoid gluteal muscle)
- May be given concomitantly with childhood vaccines using separate syringes at different sites
- Give with caution in thrombocytopenia, coagulation disorders, or anticoagulation therapy
- Do not mix with vaccines or other medications in the same syringe
Cautions
- Serious hypersensitivity reactions including anaphylaxis (urticaria, dyspnea, cyanosis, hypotonia) — initiate appropriate treatment
- Use with caution in individuals with clinically significant bleeding disorders (IM injection)
Adverse reactions
- Rash
- Injection site reactions
Pregnancy Not indicated for use in females of reproductive potential
Lactation Not indicated for use in females of reproductive potential
NO BOXED WARNINGS
Principal riskProphylaxis only; supply constrained
Classes and tags
Clinical profile
Mechanism of action: Nirsevimab ballicule
