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Born Prematurely (≤35 wGA)

If your baby was born prematurely (35 weeks or less),
he or she may be at high risk for severe RSV disease

A baby born prematurely is vulnerable to severe RSV disease while 6 months of age or younger at the start of the RSV season because he or she was born before his or her lungs and respiratory system could fully develop.

A preterm baby is also born with fewer antibodies transferred from the mother than a full term baby, making it more difficult for the baby to fight off infection.

Premature infants are at high risk for severe RSV
disease. Take the assessment now to see if
your baby is at high risk.

Take the Risk Assessment now >

Then, talk to your pediatrician about the results.

Interrupted lung development results in weaker lungs that may not be able to fight infection.
The lungs are considered weaker than the lungs of full-term infants because they:

  • Are smaller – limit the amount of room oxygen has to pass into a baby’s body with each breath
  • Have thicker walls – result in narrower openings through which air has to travel in and out of the body

Preterm babies also have fewer antibodies transferred from the mother than full-term babies.
Antibodies, the infection-fighting proteins produced by the body, are passed from mother to baby
during pregnancy. The shorter the pregnancy, the fewer the antibodies that reach the baby. This
is why preterm infants have a harder time fighting infection than full-term babies do.

A lung infection from RSV can cause clogged airways and serious breathing problems that might lead
to hospitalization. So, even though a baby may be growing and thriving, he or she may still be at high
risk for severe RSV disease because his or her lungs are not as developed as those of full-term babies.

In fact, Preterm babies (≤35 wGA) are at 2 times greater risk for
severe RSV disease than low-risk full-term babies.

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.