INDICATIONS AND USAGE
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.
• Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Recommended dosage:
Neonates and infants bom 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 x 100 mg injections).
CONTRAINDICATIONS
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.
WARNINGS AND PRECAUTIONS
• Hypersensitivity Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human IgG1 monoclonal antibodies. Initiate appropriate medications and/or supportive therapy.
ADVERSE REACTIONS
Most common adverse reactions were rash (0.9%) and injection site reactions (0.3%).
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