On Monday, the Food and Drug Administration (FDA) approved Beyfortus (nirsevimab-alip) for the prevention of Respiratory Syncytial Virus (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 through their second RSV season.

Beyfortus is a monoclonal antibody with activity against RSV. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. One dose of Beyfortus, administered as a single intramuscular injection prior to or during RSV season, may provide protection during the RSV season.

Possible side effects of Beyfortus include rash and injection site reactions. Beyfortus should not be given to infants and children with a history of serious hypersensitivity reactions to Beyfortus’ active ingredients or any of its excipients.

Beyfortus comes with warnings and precautions about serious hypersensitivity reactions, including anaphylaxis, which have been observed with other human IgG1 monoclonal antibodies. Beyfortus should be given with caution to infants and children with clinically significant bleeding disorders.

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