Advanced Consumer Information

Synagis

Generic Name: palivizumab (Intramuscular route)

pal-i-VIZ-yoo-mab

Commonly used brand name(s):

In the U.S.

Synagis

Available Dosage Forms:

Powder for Solution
Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Synagis

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 Synagis

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

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.

Geriatric

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

Proper Use of Synagis

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.

Synagis 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 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.

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