What is Beyfortus (nirsevimab)?
Beyfortus™ (nirsevimab) is a new prescription long-acting monoclonal antibody product used to help prevent a serious
lung disease caused by Respiratory Syncytial Virus (RSV). Nirsevimab is not a vaccine.
• Nirsevimab was approved by the US Food and Drug Administration (FDA) on July 17, 2023.
• On August 3, 2023, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease
Control and Prevention (CDC) voted unanimously in favor of recommending use of nirsevimab.
• The American Academy of Pediatrics recommends that all infants -- and especially those at high risk -- receive
the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus
(RSV), which is common, highly contagious and sometimes deadly.
RSV is one of the most common causes of childhood respiratory illness and results in annual outbreaks of respiratory
illnesses in all age groups. An estimated 58,000 to 80,000 children under 5 years of age, most of them infants, are
hospitalized each year nationwide due to RSV infection, with some requiring oxygen, intravenous (IV) fluids, or
mechanical ventilation (a machine to help with breathing). Each year, an estimated 100 to 300 children younger than
5 years of age die due to RSV.
Who should get Beyfortus (nirsevimab)?
Nirsevimab is recommended for:
1. All infants younger than 8 months born during or entering their first RSV season, including those recommended by
the American Academy of Pediatrics (AAP) to receive Synagis (palivizumab).
2. Infants and children aged 8 through 19 months who are at increased risk of severe RSV disease (see below) and
entering their second RSV season, including those recommended by the AAP to receive Synagis (palivizumab).
Per the FDA label, children who have received nirsevimab should not receive palivizumab for the same RSV season.
Who should not get nirsevimab?
Nirseveimab is contraindicated in individuals with a history of serious hypersensitivity reactions, including anaphylaxis, to
nirsevimab-alip or to any of the excipients.
Hypersensitivity including Anaphylaxis:
Serious hypersensitivity reactions, including anaphylaxis, have been observed rarely with other human IgG1 monoclonal
antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate
appropriate medicinal products and/or supportive therapy.
Use in Individuals with Clinically Significant Bleeding Disorders:
As with any other IM injections, Beyfortus should be given with caution to individuals with thrombocytopenia, any
coagulation disorder or to individuals on anticoagulation therapy.
Nirsevimab is not recommended if there is a previous history of RSV infection.
Administration:
Prefilled syringe given IM in the thigh.
Reactions:
Most common adverse reactions with nirsevimab were rash (0.9%) and injection site reactions (0.3%).
Beyfortus (nirsevimab)
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2023-2024 Flu Season Newsletter