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.

IMPORTANT SAFETY INFORMATION

Who should not receive SYNAGIS?

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 full Prescribing Information for SYNAGIS, including Patient Information.

To report SUSPECTED ADVERSE REACTIONS, contact (800)-236-9933(800)-236-9933.

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^TM at (866)-285-8419(866)-285-8419.