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Consequences of Severe RSV Disease

Severe RSV disease is the number 1 reason babies less than 12 months old in the United States have to be admitted to hospitals

RSV is a widespread virus that affects almost every child by the time he or she turns 2 years of age. It can infect the lungs of your preterm infant and in some cases cause severe RSV disease, leading to hospitalization.

Preterm infants (≤35 wGA) are at a high risk for RSV-related hospitalization

audreys-story

Watch Audrey's story to learn about a family's struggle with severe RSV disease.

Preterm infants (≤35 weeks GA)

  • Are two times as likely to be admitted to the hospital for RSV-related symptoms compared with infants born at full term
  • Preterm infants born at 32-35 weeks GA may stay two times longer in the hospital than infants born at full term who are hospitalized for severe RSV disease

Severe RSV disease can have a serious impact on high-risk infants

Babies who were born prematurely (≤35 wGA) or have certain heart and lung conditions (such as bronchopulmonary dysplasia/chronic lung disease of prematurity [BPD/CLDP]) often have weak lungs or other health issues.

For these babies, RSV can cause:

  • Bronchiolitis (swelling of the lower airways of the lungs)
  • Pneumonia

In the first years of life, your preterm baby faces many challenges, including the threat of severe RSV disease, but there are ways you can help.

Is your baby at high risk?
Take the Risk Assessment now.
Then, talk to your pediatrician about the results.

Take the Risk
Assessment now >

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.