What is SYNAGIS?

SYNAGIS helps protect your high-risk baby from severe RSV disease

If your baby is at high risk for severe RSV disease, you naturally want to do all you can to keep your little one at home and out of the hospital. SYNAGIS [si-nah-jis] helps protect babies from RSV through virus-fighting antibodies.

SYNAGIS is not a vaccine—it’s an injection given once a month throughout RSV season, which usually starts in the fall and continues into spring. The exact timing of RSV varies by location.

See which high-risk babies are eligible for SYNAGIS.

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How does SYNAGIS help?

SYNAGIS gives babies who are born prematurely (at or before 35 weeks, and who are 6 months of age or less at the beginning of RSV season) the infection-fighting antibodies they lack, helping protect their vulnerable lungs from RSV.

SYNAGIS can help protect children with certain lung or heart conditions who are at high risk for severe RSV disease. Children with BPD/CLDP or HS-CHD are more likely to be hospitalized with an RSV infection than those without these conditions.

Remember, SYNAGIS is not a vaccine. Children can still get severe RSV disease despite receiving SYNAGIS. If your child has an RSV infection, make sure they continue to get their monthly injections throughout the RSV season—because babies can get RSV more than once.

BPD/CLDP stands for bronchopulmonary dysplasia/chronic lung disease of prematurity.

HS-CHD stands for hemodynamically significant congenital heart disease.

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How often is SYNAGIS given?

Each dose of SYNAGIS helps protect your child from severe RSV disease for about a month. SYNAGIS should be given to high-risk babies every 28-30 days during RSV season. Talk to your doctor about a dosing schedule appropriate for your area.

It's important that babies at high risk for severe RSV disease get every injection of SYNAGIS on time throughout the RSV season.

Cradle with CareSM provides RSV information, appointment reminders, and support

What are the side effects?

While SYNAGIS can help protect your baby from RSV, you should be aware of possible side effects associated with SYNAGIS.

Possible, serious side effects of SYNAGIS include severe allergic reaction, which may occur after any dose. Such reactions may be life-threatening or cause death.

Signs and symptoms of a severe allergic reaction could include:

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Severe rash, hives,
or itching skin

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Swelling of the lips,
tongue, or face

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Swelling of the throat,
difficulty swallowing

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Difficult, rapid, or
irregular breathing

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Bluish color of skin, lips,
or under fingernails

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Muscle weakness
or floppiness

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Unresponsiveness

Common side effects of SYNAGIS include fever and rash.

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.

If your baby experiences a negative reaction to SYNAGIS, call your physician immediately.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to AstraZeneca at 1-877-633-4411.

Learn about SYNAGIS and RSV

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IMPORTANT SAFETY INFORMATION

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Who should not receive SYNAGIS?

Children 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 itchy rash; swelling of the face; difficulty swallowing; difficulty breathing; bluish color of the skin; muscle weakness or floppiness; and/or unresponsiveness. If your child has any of these signs or symptoms of a severe allergic reaction after getting SYNAGIS, call your child’s healthcare provider or get medical help right away.

IMPORTANT SAFETY INFORMATION

Who should not receive SYNAGIS?

Children 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 itchy rash; swelling of the face; difficulty swallowing; difficulty breathing; bluish color of the skin; muscle weakness or floppiness; and/or unresponsiveness. If your child has any of these signs or symptoms of a severe allergic reaction after getting SYNAGIS, call your child’s healthcare provider or get medical help right away.

How is SYNAGIS given?

SYNAGIS is given as a monthly injection, usually in the thigh (leg) muscle, by your child’s healthcare provider. If your child has a problem with bleeding or bruises easily, an injection could cause a problem. Your child should receive their first injection of SYNAGIS before the RSV season starts, to help protect them before RSV becomes active. RSV season is usually fall through spring, but it may begin earlier or last longer in certain areas. When RSV is most active, your child will need to receive injections of SYNAGIS every 28-30 days to help protect them from severe RSV disease for about a month. Your child should continue to receive monthly injections of SYNAGIS until the end of RSV season. Your child may still get severe RSV disease after receiving SYNAGIS. If your child has an RSV infection, they should continue to get their monthly injections throughout the RSV season to help prevent severe disease from new RSV infections.

The effectiveness of injections of SYNAGIS given less than monthly throughout the RSV season has not been established.

What are the possible side effects of SYNAGIS?

Serious side effects include severe allergic reactions, which may happen after any injection of SYNAGIS and may be life-threatening or cause death. Call your child’s healthcare provider or get medical help right away if your child has any of the signs or symptoms of a serious allergic reaction. See “Who should not receive SYNAGIS?” for more information.

Common side effects of SYNAGIS include fever and rash.

These are not all the possible side effects of SYNAGIS.

APPROVED USE

SYNAGIS is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in children:

  • born prematurely (at or before 35 weeks) and who are 6 months of age or less at the beginning of RSV season
  • who have a chronic lung condition called bronchopulmonary dysplasia (BPD), that needed medical treatment within the last 6 months, and who are 24 months of age or less at the beginning of RSV season
  • born with certain types of heart disease and who are 24 months of age or less at the beginning of RSV season

It is not known if SYNAGIS is safe and effective:

  • to treat the symptoms of RSV in a child who already has RSV. SYNAGIS is used to help prevent RSV disease
  • in children who are older than 24 months of age at the start of dosing

Please see full Prescribing Information for SYNAGIS, including Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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Looking for more information? We're happy to help you with any concerns or questions you may have about SYNAGIS® (palivizumab) or severe RSV disease.

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