Pronunciation:

pal-i-VIZ-yoo-mab

Brand Names:

• Synagis

Dosage Forms:

• Powder for Solution
• Solution

Classifications:

Therapeutic—

Immunological Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Palivizumab belongs to a group of medicines known as immunizing agents. Palivizumab is used to prevent infection in children and babies caused by respiratory syncytial virus (RSV). This medicine works by giving your body the antibodies it needs 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 even can 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 and in babies who were premature, and babies who were born with heart disease.

Palivizumab is used to prevent serious lower respiratory tract infection caused by the RSV.

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.

Palivizumab is to be administered only by or under the supervision of your doctor or other health care professional.

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—

Studies on this medicine have been done only in children, and it has been shown to be effective in children with breathing problems and those with a history of premature birth.

Older adults—

Studies on this medicine have been done only in infants and children, and there is no specific information about its use in older patients.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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:

• Allergy to palivizumab

Proper Use of This Medicine:

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

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 as soon as possible if any of the following side effects occur:

More common

bluish color of fingernails, lips, skin, palms, or nail beds (in patients with heart disease)

Difficulty in breathing

ringing or buzzing in the ears

skin rash

Less common or rare

Abdominal pain

diarrhea

dizziness

fainting

fast, slow, or irregular heartbeat

loss of appetite

lump in abdomen

nausea

weakness

Incidence not known

Difficult or troubled breathing

hives or welts

irregular, fast or slow, or shallow breathing

itching skin

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

loss of strength or energy

muscle pain or weakness

redness of skin

shortness of breath

tightness in chest

unresponsiveness

unusual weak feeling

wheezing

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:

Less common or rare

Cough

runny nose

sneezing

stuffy nose

vomiting

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