Beyfortus® 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 the infant as well as eligible children via IM injection. This does not require an immune response from the infant.¹
F protein, fusion protein; IM, intramuscular; RSV, respiratory syncytial virus.
F protein, fusion protein; IM, intramuscular; RSV, respiratory syncytial virus.
Yes. The Advisory Committee on Immunization Practices (ACIP) voted unanimously 11 to 0 to include Beyfortus in the Vaccines For Children (VFC) program.³
View press release
View press release
Based on clinical data, Beyfortus provides season-long RSV protection that extends through 5 months.¹
RSV, respiratory syncytial virus.
RSV, respiratory syncytial virus.
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 two IM injections (2 x 100 mg).¹
IM, intramuscular.
IM, intramuscular.
Beyfortus can be given concomitantly with other childhood vaccines.¹
There is limited experience of Beyfortus coadministration with vaccines.¹
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.¹
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
There is limited experience of Beyfortus coadministration with vaccines.¹
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.¹
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
Yes. Beyfortus injection is a sterile, latex-free, preservative-free, clear to opalescent, colorless to yellow solution for intramuscular injection.1,4
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
Contraindications
Beyfortus is contraindicated in individuals 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.
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.¹
Beyfortus is contraindicated in individuals 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.
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.¹
Serious allergic reactions have occurred with Beyfortus. The most common adverse reactions are rash (0.9%) and injection site reactions (0.3%).1 You may report side effects to FDA at 1-800-FDA-1088.
Review Adverse Reactions
Review Adverse Reactions
- Active ingredient: nirsevimab-alip
- Inactive ingredients: arginine hydrochloride, histidine, L-histidine hydrochloride, polysorbate 80, sucrose and water for injection
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
Get Beyfortus updates
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.
RSV, respiratory syncytial virus.