For US Healthcare Professionals Only

Discover Beyfortus® (nirsevimab-alip) 50 mg and 100 mg Injection

Beyfortus is the only antibody designed for season-long RSV disease protection that extends through 5 months¹

RSV, respiratory syncytial virus.
Beyfortus inhibiting RSV F (fusion) protein image

Direct, Long-Acting Antibody¹

Direct

Antibody administration directly to infant; does not rely on infant’s maturing immune system¹

Long-Acting

  • Long-acting antibody: modified to extend its half-life¹
  • RSV disease protection through 5 months based on clinical data¹

Antibody

Monoclonal antibody (mAb) that provides passive immunity by inhibiting RSV F (fusion) protein to prevent viral entry into cells¹

The first and only antibody designed to protect all infants¹

Beyfortus was approved to prevent RSV lower respiratory tract disease by the FDA in July of 2023¹˒²:

  • Neonates and infants born during or entering their first RSV season
  • Children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season

FDA approved for a broad range of infant populations entering their first season, including¹:
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Healthy or With Underlying Conditions

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Full Term or Preterm

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During or Entering the RSV season*

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.
*Epidemiology research will further define when local RSV seasons start.

The efficacy and safety of Beyfortus was evaluated in randomized, double-blind, multicenter trials for the prevention of RSV lower respiratory tract infection:

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Trial 04
(Phase 3 MELODY)

Healthy term and late preterm infants (≥35 wGA)
Study Design and Results
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Trial 03
(Phase 2b)

Healthy preterm infants (≥29 to <35 wGA)
Study Design and Results
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Trial 05
(Phase 2/3 MEDLEY)

Preterm Infants (<35 wGA) and infants born with CLD of prematurity or hemodynamically significant CHD
Study Design and Results
CHD, congenital heart disease; CLD, chronic lung disease; wGA, weeks gestational age.
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Cost and Coverage With Beyfortus

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Demonstrated Safety and Efficacy Profile¹

Explore Clinical Data
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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

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%).

Please see full Prescribing Information.

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References: 1. Beyfortus (nirsevimab-alip). Prescribing Information. Sanofi. 2.Jones JM, Fleming-Dutra KE, Prill MM, et al. Use of nirsevimab for the prevention of respiratory syncytial virus disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(34):920-925.