Nirsevimab-alip (Intramuscular)

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

RSV infection can lead to serious issues that affect the lungs, including pneumonia and bronchitis, and in severe cases, it can even be fatal. These issues are more likely to happen in infants and children younger than 6 months who have chronic lung disease and breathing problems. Babies who were born prematurely or those with heart disease may also face difficulties with RSV.

RSV activity typically starts in November and lasts until April, but it may begin earlier or continue later in some communities. A good way to help prevent RSV infection is to receive palivizumab before the RSV season starts.

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

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

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if your child has a rash, itching, a fast heartbeat, trouble breathing, trouble swallowing, or any swelling of the hands, face, or mouth after receiving the vaccine.

In deciding to use a medicine, you and your doctor must weigh the risks against the benefits. Consider the following for this medicine:

Allergies

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

Pediatric

There have not been appropriate studies on how nirsevimab-alip injection affects children older than 24 months at the start of dosing. Safety and effectiveness have not been established.

Geriatric

There is no information available on how nirsevimab-alip injection affects older adults.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. If that’s the case, your doctor may need to change the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

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

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, they may need medical attention.

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

Incidence not known

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• unusual tiredness or weakness

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or lessen some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen 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.

In the U.S.

• Beyfortus

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Nirsevimab

Find detailed information on biosimilars for this medication.

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.