Beyfortus™—
Now ACIP Recommended!
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Dosing & Administration

Beyfortus is available in a 50 mg and a 100 mg pre-filled syringe1

Based on clinical data, the duration of protection offered by a single dose of Beyfortus extends through 5 months. Beyfortus should be administered1:

  • For neonates and infants born during or entering the RSV season: starting from birth
  • For infants born outside the RSV season: once prior to the start of the season

Please see the FAQs below for additional dosing guidance.

Recommended dosage icon

Recommended Dosage1

Neonates and Infants:
First RSV Season

The recommended dosage of Beyfortus for neonates and infants born during or entering their first RSV season is based on body weight and is administered as a single intramuscular (IM) injection.

  • Neonates and infants entering their first RSV season who weigh <5 kg should be administered a 50 mg dose
  • Neonates and infants who weigh ≥5 kg should be administered a 100 mg dose

Children Who Remain Vulnerable to Severe RSV Disease: Second RSV Season

For children up to 24 months of age who remain at increased risk for severe RSV in their second RSV season, the recommended dosage of Beyfortus is a single 200 mg dose administered as 2 IM injections.

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Administering Beyfortus1

Administer the entire contents of the Beyfortus pre-filled syringe as an IM injection, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used as an injection site because of the risk of damage to the sciatic nerve.

Beyfortus can be given concomitantly with childhood vaccines.

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Storage and Handling1

Store refrigerated 36° F to 46° F (2° C to 8° C).

  • Beyfortus may be kept at room temperature 68° F to 77° F (20° C to 25° C) for a maximum of 8 hours
  • After removal from the refrigerator, Beyfortus must be used within 8 hours or discarded

Store Beyfortus in its original carton to protect from light until time of use.

Do not freeze, shake, or expose Beyfortus to heat.

How Beyfortus is supplied1

Beyfortus injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution supplied as follows:

  • Five 50 mg/0.5 mL single-dose pre-filled syringes in a carton: NDC 49281-575-15
  • Five 100 mg/mL single-dose pre-filled syringes in a carton: NDC 49281-574-15

Each Beyfortus pre-filled syringe is for one-time use only.

FAQs

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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 Including Anaphylaxis: Serious hypersensitivity reactions, including anaphylaxis, have been observed with other human IgG1 monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, initiate appropriate medications and/or supportive therapy.

  • 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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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
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.
INDICATION

Beyfortus is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in:

Reference: 1. Beyfortus (nirsevimab-alip). Prescribing Information. Sanofi.