Pronunciation:

nir-SEV-i-mab - alip

Brand Names:

• Beyfortus

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Nirsevimab

Uses of This Medicine:

Nirsevimab-alip injection is used to prevent serious lung infection in children and babies caused by respiratory syncytial virus (RSV). This medicine works by giving your body antibodies to protect it against RSV infection.

RSV infection can cause serious problems that affect the lungs, such as pneumonia and bronchitis, and in severe cases can even cause death. These problems are more likely to occur in infants and children younger than 6 months of age with chronic lung disease and breathing problems. Babies who were born premature or babies who were born with heart disease may also have problems with RSV.

The onset of RSV activity usually occurs in November and continues through April, but it may begin earlier or continue later in certain communities. A good way to help prevent RSV infection is to receive palivizumab before the start of the RSV season.

This medicine is to be given only by or under the supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of nirsevimab-alip injection in children older than 24 months of age at the start of dosing. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of nirsevimab-alip injection in geriatric patients.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make this condition worse.

• Heart surgery—Your child may need an additional dose of this medicine soon after surgery.

Proper Use of This Medicine:

A nurse or other trained health professional will give your child this medicine in a hospital. This medicine is given as a shot into one of your child's muscles, usually in the thigh.

Your child will receive this injection before or during respiratory syncytial virus (RSV) season.

This medicine comes with a patient information insert. It is very important that you read and understand this information. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

It is very important that your doctor check your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, urticaria, dyspnea, cyanosis, or hypotonia, which can be life-threatening and require immediate medical attention. Tell your doctor right away if your child has a rash, itching, bluish color of the fingernails, lips, or skin, a fast heartbeat, muscle weakness, trouble breathing, trouble swallowing, unusual weak feeling, or any swelling of your hands, face, or mouth after receiving the vaccine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

Bluish color of the fingernails, lips, or skin

chest tightness

cough

difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

muscle weakness

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.