Frequently Asked Questions About Beyfortus^®

All infants are at risk of RSV disease, regardless of age, health, or gestational age at birth.¹

Most of the time, RSV will cause mild, cold-like symptoms, making it difficult to predict which infants will develop serious RSV disease.^1,2
  

Beyfortus is not a vaccine. It’s a preventive antibody that helps infants’ maturing immune systems by providing antibodies that help protect against serious RSV-LRTD.³
  

Beyfortus is a preventive antibody that helps protect infants and certain children against RSV disease through direct administration.³
  

Based on clinical data, Beyfortus provides protection against RSV lower respiratory tract disease that extends through 5 months, the typical length of an RSV season.^3,4
  

Beyfortus was approved by the US FDA on July 17, 2023.^3,5

View press release
  

Beyfortus is a protein-directed fusion inhibitor that provides long-acting passive immunity to serious RSV disease by binding to a conserved epitope on the RSV prefusion F protein, interfering with cellular membrane fusion, and thus preventing viral entry into cells.³
  

Beyfortus RSV antibody therapy is long-acting due to a specially designed triple amino acid substitution—M252Y/S254T/T256E (YTE)—in its fragment crystallizable (Fc) region, which increases its affinity to the neonatal Fc receptor.⁶

This YTE substitution in the Fc segment of Beyfortus prolongs its serum half-life and is designed to provide season-long protection that extends through 5 months after injection with a single intramuscular dose.^3,6

Specifically, the YTE modification results in a long anti-RSV antibody half-life extension from 21–28 days to 87–117 days.^3,7
  

Beyfortus is a single dose timed to the RSV season for the vast majority of infants³:

• <5 kg weight = 50 mg dose
• ≥5 kg weight = 100 mg dose

For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of Beyfortus is recommended as soon as the child is stable after surgery; please consult the Prescribing Information for complete information on dosing in these circumstances.³ 
Second season: children up to 24 months of age, regardless of body weight, who remain vulnerable³:

• 200 mg dose administered as 2 IM injections (2 x 100 mg)

For children up to 24 months of age who remain vulnerable to RSV disease entering their second RSV season, the recommended dose of Beyfortus is a single 200 mg dose administered as 2 IM injections (2 x 100 mg).³
  

For the vast majority of infants, only one dose of Beyfortus is needed to provide season-long protection. Children up to 24 months of age who remain at increased risk for severe RSV disease may receive an additional dose during their second RSV season.³
  

Yes, Beyfortus can be administered concomitantly with childhood vaccines. There is limited experience of Beyfortus coadministration with vaccines. Beyfortus should not be mixed with any vaccine in the same syringe or vial. When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites.³
  

Yes. Beyfortus injection is a sterile, latex-free, preservative-free, clear to opalescent, colorless to yellow solution for intramuscular injection.³
  

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.³
  

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.³

Warnings and Precautions
Hypersensitivity Reactions Including Anaphylaxis:
Serious hypersensitivity reactions have been reported following Beyfortus administration. These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.³

Use in Individuals with Clinically Significant Bleeding Disorders:
As with any other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.³
  

Serious allergic reactions have occurred with Beyfortus. The most common adverse reactions are rash (0.9%) and injection site reactions (0.3%).³ You may report side effects to FDA at 1-800-FDA-1088.

Review adverse reactions  
  

Beyfortus orders are shipped immediately after ordering. Actual delivery time is not explicitly specified, but is expected to be rapid (typically within a few days, depending on distributor and location).
Order ahead of need, rather than relying on just-in-time delivery during the RSV season.
  

If you need help ordering Beyfortus:
Primary route: Call 1-800-VACCINE for ordering and logistics support.

Additional support: Request a Sanofi representative for hands-on assistance.

Call 1-855-BEYFORTUS for general product help.

Multiple support channels are available, but 1-800-VACCINE is the key contact for ordering-related questions.
  

Yes—most plans cover Beyfortus. The Affordable Care Act mandates that families with private insurance will have $0 out-of-pocket costs for an RSV preventive antibody, outside of rare exceptions.
Contact your insurance provider to confirm your coverage.
  

Yes. Beyfortus is part of the VFC program.⁸
  

Children ages 18 years or younger who meet at least one of the following requirements⁹:

• American Indian or Alaska Native
• Medicaid-eligible
• Uninsured
• Underinsured

For more information and future updates, sign up for Beyfortus emails or request to speak with a representative. For further support, call 1-855-BEYFORTUS (1-855-239-3678).

Get Beyfortus updates
  

Maternal vaccination is given to a pregnant person in order to pass antibodies to the baby during pregnancy, while Beyfortus delivers antibodies directly to the infant after birth. Beyfortus is not a vaccine and does not require the infant’s immune system to generate a response.^3,10
  

ACOG's guidance includes the importance of clinicians counseling patients on whether to administer an RSV monoclonal antibody like Beyfortus to the infant or the maternal RSV vaccine during pregnancy, and to consider patient preferences. There is no preferential recommendation for the use of maternal vaccination or monoclonal antibodies such as Beyfortus.¹¹
  

Coordinate with the infant’s pediatrician to discuss Beyfortus as a preventive option.