Beyfortus, 100 mg/mL — 1 mL Prefilled Syringe, Pack of 5

BEYFORTUS (nirsevimab-alip) Injection, 100 mg/mL

PRODUCT OVERVIEW

BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease during their second RSV season.

PRESENTATION

This product is supplied as five 1 mL single-dose prefilled syringes per carton. Each syringe contains 100 mg of nirsevimab-alip in 1 mL. BEYFORTUS is a sterile, preservative-free, clear to opalescent and colorless to yellow solution for intramuscular injection. Each prefilled syringe is intended for one-time use only.

LABELED DOSAGE CONTEXT

For neonates and infants born during or entering their first RSV season, the prescribing information recommends 50 mg for body weight below 5 kg and 100 mg for body weight of 5 kg or greater. For children up to 24 months old who remain vulnerable to severe RSV disease during their second season, the labeled dose is 200 mg given as two 100 mg intramuscular injections. BEYFORTUS must be administered by a healthcare provider. Refer to the current full prescribing information for patient selection, timing, preparation, and administration instructions.

IMPORTANT SAFETY INFORMATION

BEYFORTUS is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or any excipient. Serious hypersensitivity reactions have been reported after administration. Use caution in individuals with thrombocytopenia, coagulation disorders, or anticoagulant therapy. The label identifies rash and injection-site reactions as the most common adverse reactions.

STORAGE AND HANDLING

Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. The product may be kept at 68°F to 77°F (20°C to 25°C) for no more than 48 hours; after removal from refrigeration, use within 48 hours or discard. Do not freeze, shake, expose to heat, or use a damaged syringe.

PRODUCT DETAILS

• Brand: BEYFORTUS

• Generic name: nirsevimab-alip

• Manufacturer/labeler: Sanofi Vaccines US Inc.

• NDC: 49281-574-15 (49281057415)

• Form: Single-dose prefilled syringe

• Strength: 100 mg/mL

• Package size: Five 1 mL syringes

• Route: Intramuscular

This summary does not replace the full prescribing information. Current label: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2f08fa60-f674-432d-801b-1f9514bd9b39