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Frequently asked questions about Synagis and RSV
Synagis RSV

Q. Is Synagis a vaccine?
A. No. Even though Synagis is given as a shot, it's not a vaccine and it works differently. Each Synagis shot provides a dose of virus-fighting substances called antibodies that help prevent RSV from infecting your baby's lungs for about 28 to 30 days. That's why babies who need Synagis get monthly shots during RSV season.

Q. How many Synagis shots will my baby need?
A. If your baby is on Synagis, he or she will need one shot each month during RSV season. Your baby needs to keep getting Synagis as long as prescribed by your healthcare provider.

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Q. My baby looks healthy. Are monthly Synagis shots still necessary?
A. Yes. No matter how big and strong you baby looks, a prescription for Synagis means he or she is still at high risk for severe RSV disease. Remember, your baby's lungs are still developing and need protection from RSV. Only your doctor can tell when your baby can stop getting Synagis shots.

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Q. What should I do if my insurance won't cover Synagis?
A. While many health plans cover Synagis, the levels of coverage and the requirements for getting it can vary. If you're denied Synagis coverage or have questions about insurance, here are three resources that can help:

Synagis Reimbursement Hotline (1-877-480-8082)
For doctors, office staff, and patients who need assistance with patient benefit verifications, distributor triage, preauthorization assistance, denied claims and appeals.

MedImmune Assistance Program (1-877-480-8082)
For eligible patients who do not have health insurance (including Medicaid and Medicare) and are unable to get coverage for Synagis.

Patient Access Network Foundation (1-866-316-7263)
For patients with high co-pays and deductibles, this nonprofit organization may be able to provide support.

You can also learn more by visiting our Insurance Coverage page.

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Q. Will my baby need Synagis for a second RSV season?
A. Most babies won't need Synagis for a second season. But some babies are still at high risk for severe RSV disease in their second year and may need Synagis for more than one RSV season. Ask your doctor if your baby will need a second season of Synagis.

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Q. What is RSV season?
A. Like the flu or common cold, RSV is a seasonal virus. The season start varies from one part of the country to the next, but it usually starts in the fall and continues into the spring. In some parts of the country, such as Alaska, Hawaii and parts of Texas and Florida, for example, the length of the RSV season may be different. To find out when the season starts in your area, talk to your baby's healthcare provider.

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Q. How serious is RSV?
A. Most people with RSV suffer moderate to severe cold-like symptoms. But in some cases, RSV can be more serious. Preemies and babies born with certain types of heart disease and those with chronic lung disease are at high risk for severe RSV disease, which could lead to hospitalization or serious lung infections like pneumonia and bronchiolitis.

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Q. What are the symptoms of a severe RSV infection?
A.
  • Persistent coughing
  • Wheezing (a whistling sound when breathing)
  • Rapid breathing
  • Problems breathing, or gasping for breath
  • A bluish color around the mouth or fingernails
  • A fever. In infants under three months of age, a fever greater than 100.4°F (rectal) is a cause for concern.

Call your doctor right away if you notice any of the symptoms above.

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Q. How easy is it to catch RSV?
A. Like a common cold, RSV can be spread by sneezing and coughing or by physical contact such as kissing, touching or shaking hands. Unlike cold viruses, RSV can live up to 7 hours on countertops and other surfaces, and spreads very quickly in daycare centers and crowded households. No wonder nearly all babies will have had RSV disease by the age of two.

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Q. What could put my baby at high risk for severe RSV disease?
A. Here are some of the main factors that can increase your baby's risk for severe
RSV disease:

 
  • Premature birth. Lung infections are more common in preemies born at less than 36 weeks.
  • Having chronic lung disease. Babies two years of age or younger who have been treated for chronic lung disease within six months of the start of RSV season are at higher risk.
  • Being born with heart disease. Babies two years of age or younger who were born with certain types of heart disease are at higher risk.

Additional risk factors for premature infants may include:

  • Young chronological age. (≤12 weeks of age at the start of RSV season)
  • Being around other children, at home or in daycare. If there are toddlers and children in the house, make sure they wash their hands before they touch the baby.
  • Family history of wheezing or asthma.
  • Exposure to tobacco smoke and other air pollutants. Never let anyone smoke around your baby.
  • Multiple births. Twins, triplets and other multiples are often premature and have a low birth weight.
  • Low birth weight. (less than 5.5 pounds)
  • Crowded living conditions.
  • School-aged siblings.

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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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