FDA Approves Beyfortus (nirsevimab-alip) for Prevention of RSV Lower Respiratory Tract Disease in Neonates and Infants
The FDA has approved Beyfortus (nirsevimab-alip), a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor, for the prevention of RSV lower respiratory tract disease. This approval covers two key populations: neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The drug is administered as an intramuscular injection, with dosages tailored by body weight and age, offering a new option for RSV prophylaxis in these high-risk groups. Clinically, this approval addresses a significant need, as RSV is a common cause of lower respiratory tract infections in young children, often leading to hospitalizations. Beyfortus provides a preventive approach that can be integrated into routine care, potentially reducing the burden of severe RSV disease. The approval is based on data supporting its use in these populations, with specific guidance on dosing for different scenarios, including for children undergoing cardiac surgery with cardiopulmonary bypass.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor.
BEYFORTUS is indicated for the prevention of RSV lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Administer as an intramuscular injection. Recommended dosage: Neonates and infants born during or entering their first RSV season: 50 mg if less than 5 kg in body weight, 100 mg if greater than or equal to 5 kg in body weight. Children who remain vulnerable through their second RSV season: 200 mg (2 × 100 mg injections). For neonates and infants born during the RSV season, administer BEYFORTUS starting from birth. For neonates and infants born outside the RSV season, administer BEYFORTUS once prior to the start of the RSV season considering duration of protection provided by BEYFORTUS. For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of BEYFORTUS is recommended as soon as the child is stable after surgery to ensure adequate nirsevimab-alip serum levels. First RSV season: If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be based on body weight at the time of the additional dose. If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 50 mg regardless of body weight. Second RSV season: If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be 200 mg, regardless of body weight. If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 100 mg, regardless of body weight. BEYFORTUS must be administered by a healthcare provider. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. BEYFORTUS is a clear to opalescent, colorless to yellow solution. Do not inject BEYFORTUS if the liquid is cloudy, discolored, or it contains large particles or foreign particulate matter. Do not use if the BEYFORTUS pre-filled syringe has been dropped or damaged, the security seal on the carton has been broken, or the expiration date has passed. BEYFORTUS is available in a 50 mg and a 100 mg pre-filled syringe. Check the labels on the BEYFORTUS carton and pre-filled syringe to ensure the correct 50 mg or 100 mg product is being used. Co-administration with Childhood Vaccines and Immunoglobulin Products: BEYFORTUS can be given concomitantly with childhood vaccines. When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites. Do not mix BEYFORTUS with any vaccines or medications in the same syringe or vial. There is no information regarding co-administration of BEYFORTUS with other immunoglobulin products. Palivizumab should not be administered to infants who have already received BEYFORTUS in the same season. There are no data regarding substitution of BEYFORTUS for palivizumab once prophylaxis treatment is initiated with palivizumab for the RSV season. BEYFORTUS may be administered prior to or during the second RSV season to children up to 24 months of age who remain vulnerable to severe RSV disease, and who received palivizumab in their first RSV season.
Trial data not available in label.
Not reported in label.
Not reported in label.
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