What is severe RSV disease?

RSV is a common virus—one that can be very serious for high-risk babies

Respiratory syncytial (sin-SISH-Shull) virus, or RSV is a common virus that many parents may not have heard of. Like the flu, RSV is a seasonal virus that is easily spread. In fact, most children will get RSV by the age of 2. RSV begins with cold-like symptoms but can spread to the lungs.

For babies with certain health conditions, RSV can be very serious.

What babies are at high risk?

Babies most likely to be affected by severe RSV disease:

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Preemies

Infants who are born prematurely (born at 35 weeks or less), and who are 6 months of age or younger at the beginning of RSV season

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Babies with lung issues

Infants who have a chronic lung condition known as BPD/CLDP (bronchopulmonary dysplasia/chronic lung disease of prematurity) that required medical treatment within the previous 6 months, and who are 24 months of age or younger at the beginning of RSV season

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Babies with heart issues

Infants who have a heart condition known as HS-CHD (hemodynamically significant congenital heart disease), and who are 24 months of age or younger at the beginning of RSV season

 

Premature infants’ lungs are especially vulnerable

A premature baby (≤35 weeks gestational age), 6 months of age or younger at the start of RSV season, is at especially high risk for severe RSV disease. That's because they were born before their lungs and respiratory system could fully develop.

Unlike a full-term baby, a premature baby is also born with fewer antibodies transferred from their mother, making it more difficult for the baby to fight off infection.

Lung Development

Click on the buttons below to see lung development of babies born prematurely compared to those born full term.

Born at 30 weeks
Born at 32 weeks
Born at 34 weeks

 

Lungs of a premature baby vs lungs of a full-term baby lungs-icon lungs-icon

Preterm

Full Term(≥40 weeks GA)

34% of lung volume 60 mL vs 180 mL
26% of lung surface area 1.19 m vs 4.55 m

As you can see, the lung volume of premature infants is less than that of full term infants. A premature infant’s airways are also smaller and narrower than a full-term baby's.

Even after premature infants start to look healthy and strong, they still remain at high risk for severe RSV disease.

If your baby is at high risk for severe RSV disease, talk to your doctor about SYNAGIS and the best way to protect their lungs.

Lung Development

Click on the buttons below to see lung development of babies born prematurely compared to those born full term.

Born at 30 weeks
Born at 32 weeks
Born at 34 weeks

 

Lungs of a premature baby vs lungs of a full-term baby Lungs of a premature baby vs lungs of a full-term baby Lungs of a premature baby vs lungs of a full-term baby

Preterm

Full Term(≥40 weeks GA)

34% of lung volume 60 mL vs 180 mL
26% of lung surface area 1.19 m vs 4.55 m

As you can see, the lung volume of premature infants is less than that of full term infants. A premature infant’s airways are also smaller and narrower than a full-term baby's.

Even after premature infants start to look healthy and strong, they still remain at high risk for severe RSV disease.

If your baby is at high risk for severe RSV disease, talk to your doctor about SYNAGIS and the best way to protect their lungs.

What are the signs and symptoms of RSV?

Symptoms to watch for, especially during your baby's first months at home

While RSV is a common virus that affects almost every child by the age of 2, most babies only experience cold-like symptoms. But severe RSV disease can send some babies to the hospital.

If you see any of these warning signs of severe RSV disease, call your baby's doctor right away:

  • Coughing-Icon

    Coughing or wheezing that does not stop

  • lung-icon

    Fast or troubled breathing

  • fever-icon

    A fever (especially if it is greater than 100.4°F [rectal] in infants under 3 months of age)

  • hand-icon

    A bluish color around the mouth or fingernails

  • nose-icon

    Spread-out nostrils and/or caved-in chest when trying to breathe

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What are the consequences of severe RSV disease?

RSV is the leading cause of hospitalization of babies less than a year old

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 premature infant and, in some cases, cause severe RSV disease, leading to hospitalization.

Mom and baby image

Premature infants are at especially high risk

Premature infants (≤35 weeks GA) are twice as likely to be hospitalized for RSV-related symptoms than infants born at full term in their first 6 months of life. And the length of stay for a premature infant can be twice as long as that of an infant born at 40 weeks.

Infants with certain heart and lung conditions are also at high-risk

Babies who have conditions such BPD/CLDP or HS-CHD often have weak lungs or other health issues. For these babies, RSV can cause bronchiolitis (swelling of the lower airways of the lungs) or pneumonia.

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

HS-CHD stands for hemodynamically significant congenital heart disease.

Watch Audrey’s story to learn about one family’s struggle with severe RSV disease

PLAY VIDEO

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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