Pronunciation:

pal-i-VIZ-yoo-mab

Brand Names:

• Synagis

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Palivizumab injection is used to prevent serious lung infection in children and babies caused by respiratory syncytial virus (RSV). It belongs to a group of medicines known as immunizing agents. 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 direct 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 palivizumab 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 palivizumab 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 platelet count)—Use with caution. May make these conditions worse.

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 thighs).

This medicine is usually given once a month during the RSV season, which is the time of year that RSV is most common in your community. Your child should receive the first shot of this medicine before the season starts to help prevent serious infections from the RSV virus.

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. This will allow your child's doctor to see if the medicine is working properly and to decide if your child should continue to use it.

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if your child has a rash, itching, hoarseness, lightheadedness, dizziness, or fainting, trouble breathing, trouble swallowing, or any swelling of the hands, face, or mouth after receiving the medicine.

If your child has certain types of heart disease and needs to have a corrective surgery, your doctor may need to give your child an additional shot of this medicine soon after surgery.

Make sure any doctor or dentist who treats your child knows that he or she is using this medicine. This medicine may affect the results of certain medical tests.

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:

More common

Bluish color of the fingernails, lips, skin, palms, or nail beds

blurred vision

confusion

cough

difficulty with breathing

difficulty with swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast heartbeat

fever

hives or welts

irregular, fast or slow, or shallow breathing

itching

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of strength or energy

muscle pain or weakness

redness of the skin

shortness of breath

skin rash

sweating

tightness in the chest

unresponsiveness

unusual tiredness or weakness

wheezing

Incidence not known

Black, tarry stools

bleeding gums

blood in the urine or stools

pinpoint red spots on the skin

unusual bleeding or bruising

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:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the 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.