Synagis

Synagis is a prescription medication used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in children younger than 24 months of age (at the start of dosing). Synagis belongs to a group of drugs called monoclonal antibodies which work by preventing the virus from replicating.

This medication comes in an injectable form to be given once a month for several months.

Common side effects include fever, rash, and redness or swelling at the injection site.

Synagisis is a prescription medication that is used to help prevent a serious lung disease caused by Respiratory Syncytial Virus (RSV) in children at high risk for severe lung disease from RSV. Synagisis is for children younger than 24 months of age at the start of dosing.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Astrazeneca

• MedImmune, LLC

Synagisis may cause serious side effects including:

• Severe allergic reactions (may occur after any dose of Synagisis). Such reactions may be life-threatening or cause death.
  • See “Drug Precautions” for a list of signs and symptoms.
• Unusual bruising or groups of tiny red spots on the skin.

Call your child’s healthcare provider or get medical help right away if your child has any of the serious side effects listed above after any dose of Synagisis.

Common side effects of Synagisis include:

• fever
• rash

Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth, or discomfort).

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your child’s healthcare provider about all the medicines your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your child’s healthcare provider if your child takes a blood thinner medicine.

Your child should not receive Synagisis 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 itching skin
• swelling of the lips, tongue, or face
• closing of the throat, difficulty swallowing
• difficult, rapid, or irregular breathing
• bluish color of skin, lips, or under fingernails
• muscle weakness or floppiness
• a drop in blood pressure
• unresponsiveness

Tell your child’s healthcare provider about:

• any reactions you believe your child has ever had to Synagisis.
• any bleeding or bruising problems. Synagisis is given by injection. If your child has a problem with bleeding or bruises easily, an injection could cause a problem.
• any other medical problems.

Tell your child’s healthcare provider about all the medicines your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your child’s healthcare provider if your child takes a blood thinner medicine.

Synagisis is not for use in adults. It is not known if Synagisis will harm the unborn baby.

Synagisis is not for use in adults. It is not known if Synagisis is excreted in human breast milk.

• Synagisis is given as a monthly injection, usually in the thigh (leg) muscle, by your child’s healthcare provider. Your child’s healthcare provider will prescribe the amount of Synagisis that is right for your child (based on their weight).
• Your child’s healthcare provider will give you detailed instructions on when Synagisis will be given.
  • “RSV season” is a term used to describe the time of year when RSV infections most commonly occur (usually fall through spring in most parts of the country). During this time, when RSV is most active, your child will need to receive Synagisis shots. Your child’s healthcare provider can tell you when the RSV season starts in your area.
  • Your child should receive their first Synagisis shot before the RSV season starts to help protect them before RSV becomes active. If the season has already started, your child should receive their first Synagisis shot as soon as possible to help protect them when exposure to the virus is more likely.
  • Synagisis is needed every 28-30 days during the RSV season. Each dose of Synagisis helps protect your child from severe RSV disease for about a month. Keep all appointments with your child’s healthcare provider.
• If your child misses an injection, talk to your healthcare provider and schedule another injection as soon as possible. 
• Your child may still get severe RSV disease after receiving Synagisis; talk to your child’s healthcare provider about what symptoms to look for. If your child has an RSV infection, they should continue to get their scheduled Synagisis injections to help prevent severe disease from new RSV infections.
• If your child has certain types of heart disease and has corrective surgery, your healthcare provider may need to give your child an additional Synagisis injection soon after surgery.

The dose your doctor recommends may be based on your child's weight.

The recommended dose of Synagisis is 15 mg per kg of body weight given monthly by into the muscle (intramuscular injection).

In case of overdose, call your local Poison Control Center or seek emergency medical attention right away.