Sanofi RSV Product Summary

Beyfortus (nirsevimab-alip)

Overview

The following product summary can be used by product providers to prepare orders for fall and winter virus season.

Indications

  • All infants younger than age 8 months who are born shortly before or during their first RSV season (typically fall through spring) if:
    • The mother did not receive RSV vaccine during pregnancy
    • The mother’s RSV vaccination status is unknown
    • The infant was born less than 14 days after maternal RSV vaccination

Except in rare circumstances, nirsevimab is not needed for most infants younger than age 8 months who are born 14 or more days after their mother received RSV vaccine during pregnancy (see section on special population and situations).

  • The following children aged 8 through 19 months who are at increased risk for severe RSV disease and entering their second RSV season regardless of maternal RSV vaccination:
    • Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season
    • Children with severe immunocompromise
    • Children with cystic fibrosis who have either 1) manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable), or 2) weight-for-length <10th percentile
    • American Indian or Alaska Native children

Ordering and Return Policy

Minimum Initial Order

When ordering product directly from Sanofi, there is no minimum initial order requirement but product is sold as full packages (i.e. 5x1dose pre-filled syringes).

Pre-ordering or Reservation Programs

Providers who took part in phase I of the 2024 Beyfortus Reservation Program by submitting a forecast can qualify to participate in phase II.

From July 1 to August 31, 2024, providers who qualify to participate in phase II can reserve Beyfortus for their private pay patients with additional benefits, including:

  • Priority shipping, with reserved doses set aside
  • Ability to determine your preferred shipment schedule throughout the RSV season
  • An additional 2% reservation discount
  • 90-day payment terms
  • Ability to cancel shipment up to 5 days prior to shipment by contacting Sanofi Customer Service

By placing your direct order through VaccineShoppe.com or VaxServe.com during the reservation period, shipments will begin to arrive as early as September 2024 with additional shipments arriving as scheduled through February 2025.

Note: The Beyfortus reservation program does not apply to Vaccines for Children Program orders.  Please contact your State Immunization Program to place VFC orders.

Total order availability may be dependent on overall demand. The 2% Reservation Program discount and 90-day payment terms are only available to customers who have participated in phases I and II of the program. These benefits pertain to doses scheduled in July and August, as well as supplemental doses purchased throughout the season.

Return Policy

Unused doses of Beyfortus purchased directly from Sanofi can be returned for credit of the purchase price upon expiration.

Please reach out to Sanofi Customer Service for additional question.

Storage Requirements

Must be stored refrigerated (between 2⁰C and 8⁰C)

Diluent Type and Volume

Beyfortus does not use a diluent

Cap and Label Color (For vials)

Beyfortus 50mg (50mg/0.5ml) manufacturer-filled syringe has a purple plunger rod.

Beyfortus 100mg (100mg/1.0ml) manufacturer-filled syringe has a light blue plunger rod.

Doses

Beyfortus
How the product is supplied Manufacturer-filled syringes – 5x1 dose package
Number of doses per vial N/A
Dosage For first RSV season – 50 mg / 100 mg based on weight.
For second RSV season – 200 mg administered as two separate 100 mg injections.
Dose volume 0.5mL contains 50mg nirsevimab-alip
1.0mL contains 100mg nirsevimab-alip
Reconstitution No

Shelf Life

Shelf Life Beyfortus
Refrigerated product Current shelf life is 24 months from the time the syringes are filled during manufacturing.
Room temperature product Shelf life is 8 hours at room temperature.

Additional Information