IMPORTANT SAFETY INFORMATION
Contraindication
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. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy.
Use in Individuals with Clinically Significant Bleeding Disorders: As with other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.
Most common adverse reactions with Beyfortus were rash (0.9%) and injection site reactions (0.3%).
Please see full Prescribing Information.
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INDICATION
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.