WARNINGS
Your child should not receive BEYFORTUS if your child has a history of serious allergic reactions to nirsevimab-alip or any of the ingredients in BEYFORTUS. See the end of this Patient Information leaflet for a complete list of 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 child’s 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.
USES
What is BEYFORTUS?
BEYFORTUS is a prescription medicine that is 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. BEYFORTUS is an antibody that contains nirsevimab-alip which is used to help prevent RSV disease for 5 months. It is not known if BEYFORTUS is safe and effective in children older than 24 months of age.
HOW TO USE
How is BEYFORTUS given?
BEYFORTUS is given as an injection, usually in the thigh (leg) muscle, by your child’s healthcare provider.
Your child should receive BEYFORTUS before or during the RSV season. RSV season is the time of year when RSV infections are most common, usually occurring fall through spring. Your healthcare provider can tell you when the RSV season starts in your area.
Your child may still get RSV disease after receiving BEYFORTUS. Talk to your child’s healthcare provider about what symptoms to look for.
If your child has heart surgery, your child’s healthcare provider may need to give your child an additional BEYFORTUS injection soon after surgery.
What are the possible side effects of BEYFORTUS?
Serious allergic reactions have happened with 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,
⚬ bluish color of skin, lips or mouth, or tongue under fingernails
⚬ difficulty swallowing
⚬ muscle weakness or breathing
⚬ severe rash, hives or unresponsiveness 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 of the possible side effects of BEYFORTUS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088..
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about BEYFORTUS that is written for health professionals.
What are the ingredients in BEYFORTUS? Active ingredient: nirsevimab-alip
Inactive ingredients: arginine hydrochloride, histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injection.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Store refrigerated between 36-degrees F to 46-degrees F (2-degrees C to 8-degrees C). BEYFORTUS may be kept at room temperature 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C) for a maximum of 8 hours. After removal from the refrigerator, BEYFORTUS must be used within 8 hours or discarded.
Store BEYFORTUS in original carton to protect from light until time of use. Do not freeze. Do not shake. Do not expose to heat.
NOTES
Medication Guide: revision date 04/2026
Prescribing Information: revision date 07/2023
Nirsevimab-alip does not interfere with reverse transcriptase polymerase chain reaction (RTPCR) or rapid antigen detection RSV diagnostic assays that employ commercially available antibodies targeting antigenic site I, II, or IV on the RSV fusion (F) protein. For immunological assay results which are negative when clinical observations are consistent with RSV infection, it is recommended to confirm using an RT-PCR-based assay.
See the section WARNINGS above.
