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SYNAGIS®
(Si-na-jis)
(palivizumab) Injection

Read this Patient Information before your child starts receiving SYNAGIS and before each injection. The information may have changed. This leaflet does not take the place of talking with your child's healthcare provider about your child's condition or treatment.

What is SYNAGIS?

SYNAGIS is a prescription medication that is used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV). Your child is prescribed SYNAGIS because he or she is at high risk for severe lung disease from RSV.

SYNAGIS contains man-made, disease-fighting proteins called antibodies. These antibodies help prevent RSV disease. Children at high risk for severe RSV disease often do not have enough of their own antibodies. SYNAGIS is used in certain groups of children to help prevent severe RSV disease by increasing protective RSV antibodies.

SYNAGIS is not used to treat the symptoms of RSV disease once a child already has it. It is only used to prevent RSV disease.

SYNAGIS is not for adults or for children older than 24 months of age at the start of dosing.

Who should not receive SYNAGIS?

Your child should not receive SYNAGIS if they have ever had a severe allergic reaction to it. Signs and symptoms of a severe allergic reaction could include:

• severe rash, hives, or itching skin
• swelling of the lips, tongue, or face
• closing of the throat, difficulty swallowing
• difficult, rapid, or irregular breathing
• bluish color of skin, lips, or under fingernails
• muscle weakness or floppiness
• a drop in blood pressure
• unresponsiveness

What should I tell my child's healthcare provider before my child receives SYNAGIS?

Tell your child's healthcare provider about:

• any reactions you believe your child has ever had to SYNAGIS.
• any bleeding or bruising problems. SYNAGIS is given by injection. If your child has a problem with bleeding or bruises easily, an injection could cause a problem.
• any other medical problems.

Tell your child's healthcare provider about all the medicines your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your child's healthcare provider if your child takes a blood thinner medicine.

How is SYNAGIS given?

• SYNAGIS is given as a monthly injection, usually in the thigh (leg) muscle, by your child's healthcare provider. Your child's healthcare provider will prescribe the amount of SYNAGIS that is right for your child (based on their weight).
• Your child's healthcare provider will give you detailed instructions on when SYNAGIS will be given.
  • “RSV season” is a term used to describe the time of year when RSV infections most commonly occur (usually fall through spring in most parts of the country). During this time, when RSV is most active, your child will need to receive SYNAGIS shots. Your child's healthcare provider can tell you when the RSV season starts in your area.
  • Your child should receive their first SYNAGIS shot before the RSV season starts to help protect them before RSV becomes active. If the season has already started, your child should receive their first SYNAGIS shot as soon as possible to help protect them when exposure to the virus is more likely.
  • SYNAGIS is needed every 28-30 days during the RSV season. Each dose of SYNAGIS helps protect your child from severe RSV disease for about a month. Keep all appointments with your child's healthcare provider.
• If your child misses an injection, talk to your healthcare provider and schedule another injection as soon as possible.
• Your child may still get severe RSV disease after receiving SYNAGIS; talk to your child's healthcare provider about what symptoms to look for. If your child has an RSV infection, they should continue to get their scheduled SYNAGIS injections to help prevent severe disease from new RSV infections.
• If your child has certain types of heart disease and has corrective surgery, your healthcare provider may need to give your child an additional SYNAGIS injection soon after surgery.

What are the possible side effects of SYNAGIS?

Synagis may cause serious side effects including

• Severe allergic reactions (may occur after any dose of SYNAGIS). Such reactions may be life-threatening or cause death.
  • See “Who should not take SYNAGIS?” for a list of signs and symptoms.
• Unusual bruising or groups of tiny red spots on the skin.

Call your child's healthcare provider or get medical help right away if your child has any of the serious side effects listed above after any dose of SYNAGIS.

Common side effects of SYNAGIS include:

• fever
• rash

Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort).

These are not all the possible side effects of SYNAGIS. Tell your child's healthcare provider about any side effect that bothers your child or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to MedImmune at 1-877-633-4411.

General Information about SYNAGIS

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets.

This leaflet summarizes important information about SYNAGIS. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about SYNAGIS that is written for health professionals.

For more information, go to www.synagis.com or call 1-877-633-4411.

What are the ingredients in SYNAGIS?

Active Ingredient: palivizumab

Inactive Ingredients: chloride, glycine, and histidine

What is RSV?

Respiratory Syncytial Virus (RSV) is a common virus that is easily spread from person to person. RSV infects nearly all children by their second birthday. In most children, RSV infection is usually no worse than a bad cold. For some children, RSV infection can cause serious lung disease (like pneumonia and bronchiolitis) or breathing problems, and affected children may need to be admitted to the hospital or need emergency care.

Children who are more likely to get severe RSV disease (high-risk children) include babies born prematurely (35 weeks or less) or babies born with certain heart or lung problems.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 4/17/2012
This monograph has been modified to include the generic and brand name in many instances.