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Congenital Heart Disease

If your baby has congenital heart disease (CHD)
he or she may be at high risk for RSV disease

Normal Heart

Normal Heart

Blood low in oxygen is pumped from the
heart to the lungs. Blood high in oxygen is
returned from the lungs to the heart and
pumped to the rest of the body.

A baby with CHD is vulnerable to severe RSV disease while 24 months of age or younger at the start of the RSV season because he or she was born with a defect in his or her heart.

There are many different kinds of heart conditions, such as:

  • The heart is not pumping well
  • A heart valve isn't working the way it should
  • There has been damage to the chamber or blood vessel
  • The baby was born without a chamber
  • There is a hole in the baby’s heart

CHD can raise your baby’s risk of severe RSV disease.
Take the Risk Assessment now.

Take the Risk Assessment now >

Then, talk to your pediatrician about the results.

What is shunting?

Your baby's heart and lungs have to work together, so CHD can also create lung problems. When there is a hole in the baby’s heart, this causes blood to flow in an incorrect pattern in a process called shunting:

Left-to-Right Shunting

Right-to-left

Mixed lesions with cyanosis

  • Oxygen-rich Blood
  • Oxygen-poor Blood
  • Mixed

This type of heart defect has the characteristics of left-to-right shunting as well as right-to-left shunting. It can result in too much or too little blood flow to the baby’s lungs.

  • Increased or decreased flow of blood to the lungs impacts a baby’s ability to fight off lung infection, making severe RSV disease a greater concern for these babies.

Babies with CHD have an increased risk for severe RSV disease, especially while 24 months of age or younger at the start of the RSV season, and are 2 to 3 times more likely than lower-risk babies to be hospitalized for severe RSV infection.

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.