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Why monthly dosing

Synagis should be given every 28–30 days during RSV season

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

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  • RSV season usually starts in the fall and continues into spring, but the season may be different where you live. Your first step should be talking to your high-risk baby's doctor to find out when RSV season starts and ends in your area
  • If your high-risk baby was born during RSV season, he or she may have received the first dose of Synagis in the NICU
  • During RSV season, high-risk babies should continue receiving Synagis every 28–30 days
  • Each dose of Synagis helps protect your child from severe RSV disease for about a month

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

Synagis is NOT a vaccine.

  • One Synagis shot helps protect your high-risk baby for about 28–30 days, so missing or delaying just one shot could put your baby at risk for severe RSV disease
  • Make sure you plan ahead for your high-risk baby's first Synagis shot and keep the rest of your baby's shots on schedule throughout the RSV season

High-risk babies born before RSV season starts will still be at an increased risk for severe RSV disease when the season begins.

Your high-risk baby's dosing schedule will depend on when he or she was born and when RSV season starts and ends in your area.

High-risk babies born after the start of RSV season may get their first shot in the NICU. They should continue to get one Synagis shot every 28–30 days for the rest of the season.

Make sure you talk to your high-risk baby's doctor about how many shots your baby will need and when they will start.

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.