Beyfortus® can help protect against respiratory syncytial virus (RSV)

Beyfortus®, an immunizing agent, protects your baby from getting RSV disease in their first RSV season. It may also be given to children less than 2 years of age who are vulnerable to severe RSV disease in their second RSV season.

Beyfortus® stops the virus from entering and infecting human cells and provides direct and timely protection against RSV disease to last for at least 5 months, corresponding to a typical RSV season.

Learn more about RSV

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How is RSV spread?

RSV spreads when droplets from a cough, sneeze, or infected surface get inside the eyes, nose, or mouth.

How can I protect myself and my infant?

Beyfortus®, an immunizing agent, protects your baby from getting RSV disease in their first RSV season. It may also be given to children less than 2 years of age who are vulnerable to severe RSV disease in their second RSV season.

Parent holding baby

Who should use an immunizing agent?

While the risk of a severe infection with RSV is higher in infants born premature and with underlying conditions, all infants entering their first season can be infected with RSV and hence could benefit from a passive immunizing agent for RSV. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia (infection of the lungs) in children younger than 1 year of age in the United States, and most children will have had an RSV infection by their second birthday.

Do not immunize in:

  • children over 24 months of age
  • anyone with a known severe allergy to immunizing agents or any of its components. To help avoid side effects and ensure proper use, talk to your healthcare provider before your child takes Beyfortus®. Talk about any health conditions or problems they may have, including if they have any allergies to this immunizing agent or its ingredients or components of the container

Possible side effects

Uncommon side effects (may affect up to 1 in 100 children) may include:

  • Rash
  • Injection site reaction (i.e. redness, swelling, and pain where the injection is given)
  • Fever

These are not all the possible side effects your child may have after being administered Beyfortus®. If your child experiences any side effects not listed here, tell your child’s healthcare professional.

Baby holding parent’s finger

Will my child ever need another Beyfortus®?

Beyfortus® is recommended as a single fixed dose given as two intramuscular injections. However, for individuals undergoing cardiac surgery with cardiopulmonary bypass, it is recommended that an additional dose is administered as soon as the individual is stable after surgery.

Ask your healthcare practitioner about Beyfortus®

    Beyfortus® (nirsevimab injection) is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:

    • Neonates and infants during their first RSV season.
    • Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, which may include but is not limited to children with: chronic lung disease of prematurity (CLD), hemodynamically significant congenital heart disease (CHD), immunocompromised states, Down syndrome, cystic fibrosis, neuromuscular disease, and congenital airway anomalies.

    Clinical use
    Safety and efficacy in children older than 24 months of age have not been established. Safety and efficacy in infants with body weight below 1.6 kg have not been established. Dosing in infants with a body weight from 1.0 kg to <1.6 kg is based on extrapolation. The efficacy in infants who remain vulnerable to severe RSV disease during their first or second RSV season has not been directly established and is based on extrapolation of exposure only.

    There is limited information available in extremely preterm infants (Gestational Age [GA] <29 weeks) less than 8 weeks of age, and no clinical data are available in infants with a postmenstrual age (gestational age at birth plus chronological age) of 32 weeks. Limited data are available in infants with Down syndrome (n=13), cystic fibrosis (n=5), congenital airway anomalies (n=9), and neuromuscular disease (n=0; not evaluated in clinical trials).

    Not indicated in the geriatric population (≥65 years of age).

    Relevant warnings and precautions

    • Should be given with caution to individuals with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.
    • Serious hypersensitivity reactions, including anaphylaxis, have been observed rarely with other IgG1 monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medicinal products and/or supportive therapy.
    • Pregnant and nursing women: not indicated for adults.

    For more information
    Please refer to the Product Monograph for important information relating to adverse events, drug interactions, dosing and conditions of clinical use. The Product Monograph is also available by calling 1-800-265-7927.

    Sanofi & AstraZeneca are collaborating on the development and commercialization of Beyfortus®.