Prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease (LRTD) in: 1.Neonates and infants born during or entering their first RSV season 2.Children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season

Antiviral-Monoclonal Antibodies

1.Route / absorption: IM administration; estimated absolute bioavailability ~84%; median Tmax 6 days (range 1–28). Distribution: estimated Vd 477 mL (for an infant weighing 5 kg). 2.Elimination: terminal half-life ~71 days; estimated clearance 3.42 mL/day (for an infant weighing 5 kg). 3.Metabolism: degraded into small peptides via catabolic pathways. 4.Renal/hepatic impairment: effect on PK not expected. 5.Duration of protection: clinical data support protection through 5 months after a single dose.

Contraindicated in infants/children with a history of serious hypersensitivity reactions (including anaphylaxis) to nirsevimab-alip or any excipients.

Not applicable per label: “BEYFORTUS is not indicated for use in females of reproductive potential.”

Not applicable per label: “BEYFORTUS is not indicated for use in females of reproductive potential.”

Most common adverse reactions: Rash (0.9%) Injection site reactions (0.3%)

1.Route: Intramuscular (IM) injection. 2.First RSV season (single IM dose, weight-based) <5 kg: 50 mg IM x 1 ?5 kg: 100 mg IM x 1 3.Second RSV season (up to 24 months, increased risk): 200 mg IM x 1 given as two 100 mg IM injections. 4.Concomitant vaccines: may be given with routine childhood vaccines using separate syringes and different injection sites; do not mix in the same syringe/vial. 5.Cardiac surgery with cardiopulmonary bypass: additional dose recommended post-surgery; dosing depends on timing since prior dose and RSV season (details in label)

1.BEYFORTUS is inherently pediatric-indicated, and dosing is already weight/season-based as above (first season 50/100 mg; second season 200 mg).2.Safety/effectiveness not established >24 months.

No dosage adjustment is provided; renal impairment effect on PK is not expected.

No dosage adjustment is provided; hepatic impairment effect on PK is not expected.

1.Store refrigerated 2°C to 8°C (36°F to 46°F).May be kept at room temperature 20°C to 25°C (68°F to 77°F) for up to 8 hours. 2.After removal from refrigerator, use within 8 hours or discard. 3.Protect from light (keep in original carton). 4.Do not freeze. Do not shake. Do not expose to heat.