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What is SYNAGIS?

SYNAGIS helps protect your high-risk baby from severe RSV disease

If your baby is at high risk for severe RSV disease, you naturally want to do all you can to keep your little one at home and out of the hospital. SYNAGIS [si-nah-jis] helps protect babies from RSV through virus-blocking antibodies.

SYNAGIS is not a vaccine—it’s an injection given once a month throughout RSV season, which usually starts in the fall and continues into spring. The exact timing of RSV varies by location.

See which high-risk babies are eligible for SYNAGIS.

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How does SYNAGIS help?

SYNAGIS gives babies who are born prematurely (at or before 35 weeks, and who are 6 months of age or less at the beginning of RSV season) the virus-blocking antibodies they lack, helping protect their vulnerable lungs from RSV.

SYNAGIS can help protect children with certain lung or heart conditions who are at high risk for severe RSV disease. Children with BPD/CLDP or HS-CHD are more likely to be hospitalized with an RSV infection than those without these conditions.

Remember, SYNAGIS is not a vaccine. Children can still get severe RSV disease despite receiving SYNAGIS. If your child has an RSV infection, make sure they continue to get their monthly injections throughout the RSV season—because babies can get RSV more than once.

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

HS-CHD stands for hemodynamically significant congenital heart disease.

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How often is SYNAGIS given?

Each dose of SYNAGIS helps protect your child from severe RSV disease for about a month. SYNAGIS should be given to high-risk babies every 28-30 days during RSV season. Talk to your doctor about a dosing schedule appropriate for your area.

It's important that babies at high risk for severe RSV disease get every injection of SYNAGIS on time throughout the RSV season.

Cradle with CareSM provides RSV information, appointment reminders, and support

What are the side effects?

While SYNAGIS can help protect your baby from RSV, you should be aware of possible side effects associated with SYNAGIS.

Possible, serious side effects of SYNAGIS include severe allergic reaction, which may occur after any dose. Such reactions may be life-threatening or cause death.

Signs and symptoms of a severe allergic reaction could include:

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Severe rash, hives,
or itching skin

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Swelling of the lips,
tongue, or face

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Swelling of the throat,
difficulty swallowing

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Difficult, rapid, or
irregular breathing

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Bluish color of skin, lips,
or under fingernails

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Muscle weakness
or floppiness

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Unresponsiveness

Common side effects of SYNAGIS include fever and rash.

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.

If your baby experiences a negative reaction to SYNAGIS, call your physician immediately.

To report SUSPECTED ADVERSE REACTIONS, contact 1-866-773-52741-866-773-5274.

Learn about SYNAGIS and RSV

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IMPORTANT PRODUCT INFORMATION

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INDICATION

SYNAGIS, 50 mg and 100 mg for injection, 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

IMPORTANT PRODUCT INFORMATION

INDICATION

SYNAGIS, 50 mg and 100 mg for injection, 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

SYNAGIS contains man-made, disease-fighting proteins called antibodies. 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. It is not known if SYNAGIS is safe and effective in children who are older than 24 months of age at the start of dosing.

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 severe rash, hives, or itchy skin; swelling of the lips, tongue, or face; swelling of the throat, difficulty swallowing; difficult, rapid, or irregular breathing; bluish color of skin, lips, or under fingernails; muscle weakness or floppiness; 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.

Before your child receives SYNAGIS, tell your child’s healthcare provider about all of your child’s medical conditions, including if your child:

  • has ever had a reaction to SYNAGIS
  • has bleeding or bruising problems

SYNAGIS is given by injection. If your child has a problem with bleeding or bruises easily, an injection could cause a problem.

Tell your child’s healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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.

The most common side effects of SYNAGIS include fever and rash.

These are not all the possible side effects for SYNAGIS. For more information ask your child’s healthcare provider.

  • Please see full Prescribing Information for SYNAGIS, including Patient Information.

    To report suspected adverse reactions, contact Sobi North America at 1-866-773-5274 or the FDA at 1-800-FDA-1088.

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    Contact Us X

    AstraZeneca has transferred all rights to SYNAGIS (palivizumab) to another manufacturer, Swedish Orphan Biovitrum AB (SOBI), in January of 2019. If you need SYNAGIS support, please contact SYNAGIS CONNECT® at (866)-285-8419(866)-285-8419.

    RSV=respiratory syncytial virus.
    All imagery is for illustrative purposes only.