Synagis®: How it works to help protect high-risk babies from severe RSV

Synagis is the only FDA-approved medication to help protect high-risk babies from severe RSV disease. Even though Synagis is given as a shot by your healthcare provider, it's not a vaccine and it works differently. Each Synagis shot provides a dose of virus-fighting substances called antibodies that help prevent severe RSV disease from infecting your baby's lungs.

There are enough antibodies in one Synagis shot to help protect your baby's lungs for about 28-30 days. That′s why it′s important to get every single shot on schedule during RSV season. Missing or delaying just one shot could put your baby at increased risk for severe RSV disease.

Synagis is meant to help prevent serious RSV disease. If your baby already has RSV, you should work with your doctor to help treat the symptoms. Your doctor may then recommend Synagis to help prevent any future cases of severe RSV disease.

How Synagis helps high-risk babies

Preemies are often born before getting enough antibodies from their mothers to help fight RSV and other viruses. But preemies are also at greater risk for severe RSV disease because their lungs are less developed and their airways are narrower than those of full-term babies. Synagis helps preemies by providing more infection-fighting antibodies to help protect their vulnerable lungs from RSV.

The first Synagis shot should be given before RSV season starts.

Babies born with certain types of heart disease and those with chronic lung disease also need help fighting RSV. These babies are more likely to be hospitalized due to an RSV infection. The antibodies in Synagis help prevent these babies from developing severe RSV disease.

What to expect

Common side effects after receiving Synagis include fever, cold-like symptoms (upper respiratory tract infection), including runny nose and ear infection, and rash. Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth or discomfort). In children born with certain heart problems, other possible side effects include bluish color of the skin and abnormal heart rhythms. Possible, serious side effects include severe allergic reaction which can occur after any dose of Synagis, not just the first one. Unusual bruising and/or groups of tiny red spots on the skin have also been reported.

These are not all the possible side effects of Synagis. Tell your child's healthcare provider about any side effect that bothers your child or that does not go away. For more information about what to expect, please see the Important Saftey Information below.

Important Safety Information

What is Synagis® (palivizumab)?

Synagis is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in infants and children at high risk for severe lung disease from RSV. Over one million children have been given Synagis. It is given as a shot, usually in the thigh muscle, each month during the RSV season. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season.

Who should not receive Synagis?

Synagis should not be used in children who have ever had a severe allergic reaction to Synagis or its ingredients. Signs and symptoms of a severe allergic reaction could include: itchy rash; difficulty breathing; difficulty swallowing; swelling of the face; 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, be sure to tell your child's healthcare provider or get medical help right away.

What are the side effects with Synagis?

Possible, serious side effects include severe allergic reaction which may occur after any dose of Synagis. Unusual bruising and/or groups of tiny red spots on the skin have also been reported.

Common side effects of Synagis include fever, cold-like symptoms (upper respiratory tract infection), including runny nose and ear infection, and rash. Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth or discomfort). In children born with certain heart problems, other possible side effects include bluish color of the skin and abnormal heart rhythms.

These are not all the possible side effects of Synagis. Tell your child's healthcare provider about any side effect that bothers your child or that does not go away.

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