Description
Nirsevimab-alip injection is used to prevent serious lung infection caused by respiratory syncytial virus (RSV). This medicine is given to newborns and babies under 1 year of age during or entering their first RSV season. It is also given to children up to 24 months of age who are still at risk of RSV disease through their second RSV season. 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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
No information is available on the relationship of age to the effects of nirsevimab-alip injection in geriatric patients.
Breastfeeding
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.
Drug Interactions
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
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
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
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.
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