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Overview: Beyfortus is a shot that is given to newborns and babies who are born during or entering their first respiratory syncytial virus (RSV) season and certain older children. Beyfortus helps protect them for several months from lung disease like pneumonia or bronchiolitis caused by RSV. Your child may have swelling or pain where the shot is given. Get help right away if your child has any symptoms of a serious allergic reaction, such as trouble breathing or swelling of the face, mouth, or tongue. 

Uses

What is Beyfortus used for?

Beyfortus (nirsevimab-alip) is commonly given to help prevent lower respiratory tract disease (such as pneumonia or bronchiolitis) caused by respiratory syncytial virus (RSV) in certain children. RSV is a common, contagious virus that causes symptoms like cough and runny nose. In most people, RSV is mild. However, in babies and certain older children, RSV can cause serious problems. This medicine will not give your child RSV. It also will not treat an infection.

How does Beyfortus work (mechanism of action)?

Beyfortus is an injection that delivers a type of protein (antibody) that protects against respiratory syncytial virus (RSV). This antibody helps block the virus from entering cells, which may prevent lower respiratory tract disease caused by RSV. This is called passive immunization, which leads to passive immunity. Beyfortus offers protection throughout the RSV season (at least five months).

How is Beyfortus supplied (dosage forms)?

Beyfortus is available in an injectable form that is given by a health care provider.

How should I store Beyfortus?

Beyfortus is usually given by a health care provider in a hospital, clinic, or pediatrician’s office. You will not store it at home.

Side Effects

What are the most common side effects of Beyfortus?

The most common side effects of Beyfortus are listed below. Tell your health care provider if your child has any of these side effects that bothers them.

  • Rash 
  • Pain, swelling, or hardness near the injection site

There may be other side effects of Beyfortus that are not listed here. Contact your health care provider if you think your child is having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Beyfortus?

While less common, the most serious side effects of Beyfortus are described below, along with what to do if they happen.

Severe Allergic Reactions. Beyfortus may cause allergic reactions, which can be serious. Get help right away if your child has any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Muscle weakness
  • Skin, lips, or area under the fingernails is bluish in color
  • Not responding

Warnings & Precautions

Who should not use Beyfortus?

Allergies to Ingredients. People who are allergic to any of the following should not use Beyfortus.

  • Nirsevimab-alip
  • Beyfortus
  • Any of the ingredients in Beyfortus

Your child’s health care provider can tell you all of the ingredients in Beyfortus.

What should I know about Beyfortus before using it?

Beyfortus is usually given by a healthcare provider in a hospital, clinic, or pediatrician’s office.

If your child needs childhood vaccines, they can be given on the same day as Beyfortus. Vaccines will be given using separate syringes and different injection sites.

Your child should receive Beyfortus before or during respiratory syncytial virus (RSV) season, which is usually fall through spring. Your child’s health care provider can tell you when RSV season starts in your area, and when your child should receive Beyfortus. 

Your child may still get RSV disease, even after receiving Beyfortus. Ask your child’s health care provider about what symptoms to look for.

Tell your child's health care provider If you got a vaccine during pregnancy or your baby has already received a medicine to help prevent RSV. Many options exist to help prevent RSV in a baby. If your child receives Beyfortus, they should not receive a medicine called palivizumab (Synagis) in the same season. Ask your child’s health care provider if you have any questions or concerns.

What should I tell my healthcare provider before using Beyfortus?

Tell your child’s health care provider about all of your child’s health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements your child is using. This will help them determine if Beyfortus is right for your child.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your child’s health care provider if your child has any of the following.

  • A history of Guillain-Barré Syndrome (GBS)
  • Fever or recent illness
  • A weak immune system, get infections easily, or take medicines or treatments that suppress the immune system such as radiation or chemotherapy
  • A history of any type of reaction after any vaccine
  • Low platelet levels (thrombocytopenia)
  • Bleeding, bruising, or blood clotting problems
  • Heart conditions or heart surgery with cardiopulmonary bypass (a heart-lung machine that takes over the heart and lung functions during the procedure)

Blood Thinner Medicine. Tell your child’s health care provider if your child takes blood thinner medicine.

Pregnancy. People who can become pregnant are not usually given Beyfortus.

Breastfeeding. People who can breastfeed are not usually given Beyfortus.

How can I get more information about Beyfortus?

For more information about Beyfortus, you can visit the drugmaker’s website at www.beyfortus.com or call them at 855-239-3678.

Interactions

Does Beyfortus interact with foods or drinks?

There are no known interactions between Beyfortus and foods or drinks.

Does Beyfortus interact with other medicines (drug interactions)?

There are no known interactions between Beyfortus and other medicines. Always tell your child’s health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements your child is using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Beyfortus?

If you or someone else has used too much Beyfortus, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Beyfortus?

Beyfortus is usually given as a one-time dose by a health care provider in a hospital, clinic, or pediatrician’s office. If you miss an appointment for your child to receive Beyfortus, call to make another appointment as soon as possible.