Nirsevimab

BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (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. 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.

BEYFORTUS is a monoclonal antibody with anti-RSV activity.

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).

BEYFORTUS is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients.

Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions have been reported following BEYFORTUS administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.

Most common adverse reactions were rash (0.9%) and injection site reactions (0.3%).

Interference with RT-PCR or Rapid Antigen Detection RSV Diagnostic Assays Nirsevimab-alip does not interfere with reverse transcriptase polymerase chain reaction (RT-PCR) or rapid antigen detection RSV diagnostic assays that employ commercially available antibodies targeting antigenic site I, II, or IV on the RSV fusion (F) protein. For immunological assay results which are negative when clinical observations are consistent with RSV infection, it is recommended to confirm using an RT-PCR-based assay.

Store refrigerated between 36°F to 46°F (2°C to 8°C). BEYFORTUS may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 48 hours. After removal from the refrigerator, BEYFORTUS must be used within 48 hours or discarded. Do not freeze. Store BEYFORTUS in original carton to protect from light until time of use. Do not shake.