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Sanofi Beyfortus™ (nirsevimab-alip) Injection Update

November 17, 2023

There has been unprecedented demand for Beyfortus™ (nirsevimab-alip) 50 mg and 100 mg Injection. For the first time in history, health care providers are able to help protect an extraordinary number of infants against respiratory syncytial virus (RSV) disease.

Despite an aggressive supply plan built to outperform past pediatric immunization launches, demand for this product, in both the 50 and 100 mg doses, has been higher than anticipated.

We previously communicated that new orders for the 100 mg dose were no longer being accepted, as the demand exceeded the available supply for the season.

Thanks to the support and partnership of the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) more than 77,000 additional 100 mg doses have been made available for babies for this RSV season.

These additional 100 mg doses are being equitably distributed through the Vaccines for Children Program and the private market on a limited basis. Remaining 50 mg doses will also continue to be distributed similarly on a limited basis in fulfillment of existing orders.

Sanofi will continue to update providers in the private market about the status of their orders and any potential availability of additional doses for shipment.

We, along with our alliance partner AstraZeneca, in charge of manufacturing, remain in close contact with the CDC and FDA to deliver doses for this RSV season.

INDICATION

Beyfortus is a prescription medicine used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in:

  • Newborns and babies under 1 year of age born during or entering their first RSV season.
  • Children up to 24 months of age who remain at risk of severe RSV disease through their second RSV season.

IMPORTANT SAFETY INFORMATION

Your child should not take Beyfortus if your child has a history of serious allergic reactions to nirsevimab-alip or any of the ingredients in Beyfortus.

Before your child receives Beyfortus, tell your healthcare provider about all of your child’s medical conditions, including if your child:

  • has ever had a reaction to Beyfortus.
  • has bleeding or bruising problems. If your child has a problem with bleeding or bruises easily, an injection could cause a problem.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your infant should not receive a medicine called palivizumab if they have already received Beyfortus in the same RSV season.

Serious allergic reactions have happened with other medicines like Beyfortus. Get medical help right away if your child has any of the following signs or symptoms of a serious allergic reaction:

  • swelling of the face, mouth, or tongue
  • difficulty swallowing or breathing
  • unresponsiveness
  • bluish color of skin, lips, or under fingernails
  • muscle weakness
  • severe rash, hives, or itching

The most common side effects of Beyfortus include rash and pain, swelling, or hardness at the site of your child’s injection. These are not all the possible side effects of Beyfortus. Call your healthcare provider if you have questions about side effects.

Please see full Prescribing Information, including Patient Information for more details.

About Sanofi

We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY

Media Relations
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com

 

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