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Beyfortus® (nirsevimab-alip) 50 mg and 100 mg Injection Frequently Asked Questions


Beyfortus is not a vaccine or maternal immunization. Beyfortus is an RSV F protein-directed fusion inhibitor monoclonal antibody indicated for the prevention of RSV lower respiratory tract disease—directly administered to infant as well as eligible children via IM injection. This does not require an immune response from the infants.1

F protein, fusion protein; IM, intramuscular; RSV, respiratory syncytial virus.

Beyfortus was approved by the US FDA on July 17, 2023.1,2

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Yes. The Advisory Committee on Immunization Practices (ACIP) voted unanimously, 11 to 0, to include Beyfortus in the VFC program.3

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Based on clinical data, Beyfortus provides RSV protection that extends through 5 months, the typical length of an RSV season.1

RSV, respiratory syncytial virus.

For children up to 24 months of age, regardless of body weight, who remain at increased risk for severe RSV, the recommended dosage of Beyfortus is a single 200 mg dose administered as 2 IM injections (2 x 100 mg).1

IM, intramuscular; RSV, respiratory syncytial virus.

Beyfortus can be administered concomitantly with childhood vaccines.

There is limited experience of Beyfortus coadministration with vaccines.

In clinical trials, when Beyfortus was given with routine childhood vaccines, the safety and reactogenicity profile of the coadministered regimen was similar to the childhood vaccines given alone.

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.1

Both 1-pack and 5-pack cartons are available.1

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Yes. Beyfortus injection is a sterile, latex-free, preservative-free, clear to opalescent, colorless to yellow solution for intramuscular injection.1

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.1

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.1

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.1

Use in Individuals With Clinically Significant Bleeding Disorders
As with any other IM intramuscular injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.1

Serious allergic reactions have occurred with Beyfortus. The most common adverse reactions are rash (0.9%) and injection site reactions (0.3%). You may report side effects to the FDA at 1-800-FDA-1088.1 

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  • Active ingredient: nirsevimab-alip1
  • Inactive ingredients: arginine hydrochloride monohydrate, histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injection1

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).

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Please refer parents to the Centers for Disease Control and Prevention (CDC) for information on RSV and to Beyfortus.com for more information on Beyfortus.

RSV, respiratory syncytial virus.

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 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.

  • 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%).

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.

Important Safety Information

Indication

References: 1. Beyfortus (nirsevimab-alip). Prescribing Information. Sanofi. 2. FDA approves new drug to prevent RSV in babies and toddlers. News Release. FDA. July 17, 2023. Accessed May 26, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers 3. U.S. CDC Advisory Committee unanimously recommends routine use of Beyfortus™ (nirsevimab-alip) to protect infants against RSV disease. News Release. Sanofi. August 03, 2023. Accessed May 26, 2025. https://www.sanofi.com/en/media-room/press-releases/2023/2023-08-03-19-21-36-2718475

MAT-US-2310577-v5.0-06/2025