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What is Synagis?

Help protect your high-risk baby from severe RSV disease with Synagis

Though not a vaccine, Synagis [si-nah-jis] is an FDA-approved prescription injection of antibodies that is given monthly to help protect high-risk infants from severe RSV disease throughout the RSV season.

  • Synagis contains virus-fighting antibodies that can help protect high-risk infants from severe RSV disease
  • Each dose is needed every 28–30 days
  • 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 shots throughout the RSV season to help prevent severe disease from new RSV infections.

It's important for high-risk babies to get every Synagis injection on time throughout the RSV season.

How Synagis helps high-risk babies

Premature babies are born at 35 weeks or less

  • Preemies are often born before getting enough antibodies from their mothers to help fight RSV. They are also at increased risk for severe RSV disease because their lungs are less developed and their airways are narrower than those of full-term babies
  • Synagis provides infection-fighting antibodies to help protect their vulnerable lungs from RSV

Children 24 months or less with bronchopulmonary dysplasia/chronic lung disease of prematurity (BPD/CLDP) and/or hemodynamically significant congenital heart disease (CHD)

  • Children born with certain types of heart disease and those with certain types of chronic lung disease are more likely to be hospitalized due 
to an RSV infection
  • The antibodies in Synagis help prevent these babies from developing severe RSV disease

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 accompanying full Prescribing Information for SYNAGIS, including Patient Information.