Beyfortus 50 mg/0.5 mL intramuscular syringe

Generic name:
Nirsevimab - injection

Pronunciation
(nir-SEV-i-mab)

Brand name(s)
Beyfortus

Nirsevimab is used by infants and certain young children to prevent serious lung infections (such as pneumonia) that are caused the respiratory syncytial virus (RSV). Nirsevimab belongs to a class of drugs known as monoclonal antibodies. It works by preventing the growth of the virus.

Read the Patient Information Leaflet if available from the health care professional before your child receives nirsevimab. If you have any questions, ask the doctor or pharmacist.

This medication is given by injection into a muscle by a health care professional. It is usually given in the upper thigh. It is given as directed by your child's doctor, usually as a single dose before or during the child's first RSV season. RSV season in the northern hemisphere usually starts in October and runs through April. The dosage is based on your child's weight.

Some children may need another dose of nirsevimab to get the best protection. Closely follow the treatment schedule provided by the doctor.

Pain, redness, or swelling at the injection site may occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• bluish skin/lips
• muscle weakness
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before receiving nirsevimab, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before receiving this medication, tell the doctor or pharmacist your child's medical history, especially of:

• bleeding/blood clotting problems (such as low platelets, coagulation disorder)

Before having surgery (especially certain heart procedures), tell the doctor or dentist about this medication and all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not usually used by adults. It is unlikely to be used during pregnancy or breastfeeding. Consult the doctor if you have any questions about this medication.

Drug interactions may change how your child's medications work or increase the risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Keep all medical and lab appointments.

Not applicable.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.