infants at highest risk of RSV

FOR PREMATURE INFANTS OR CHILDREN WITH BPD/CLDP OR HS-CHD

SYNAGIS®—OVER 25 YEARS OF PROVEN PROTECTION* AGAINST SEVERE RSV DISEASE1

*In the pivotal IMpact-RSV study of preterm children with and without BPD, the RSV hospitalization rate was 4.8% in the SYNAGIS group and 10.6% in the placebo group (P<0.001).2

Learn More About the Highest-Risk RSV Patients

Very Preterm Infants

BPD/CLDP

HS-CHD

BPD=bronchopulmonary dysplasia; CLDP=chronic lung disease of prematurity; HS-CHD=hemodynamically significant congenital heart disease; RSV=respiratory syncytial virus.

REFERENCES: 1. SYNAGIS (palivizumab) [prescribing information]. Waltham, MA: Sobi, Inc. 2021. 2. The IMpact-RSV Study Group. Palivizumab, a humanized respiratory syncytial virus monoclonal antibody, reduces hospitalization from respiratory syncytial virus infection in high-risk infants. Pediatrics. 1998;102(3):531-537.

All imagery is for illustrative purposes only. 

INDICATION

SYNAGIS, 50 mg and 100 mg for injection, is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:

  • with a history of premature birth (≤35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season
  • with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season
  • with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season

Limitations of Use

The safety and efficacy of SYNAGIS have not been established for treatment of RSV disease.

INDICATION & IMPORTANT SAFETY INFORMATION

INDICATION

SYNAGIS, 50 mg and 100 mg for injection, is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients:

  • with a history of premature birth (≤35 weeks gestational age) and who are 6 months of age or younger at the beginning of RSV season
  • with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season
  • with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season

Limitations of Use

The safety and efficacy of SYNAGIS have not been established for treatment of RSV disease.

Contraindications

Previous significant hypersensitivity reaction to SYNAGIS.

Warnings and Precautions

Hypersensitivity Reactions: Anaphylaxis and anaphylactic shock (including fatal cases) and other severe acute hypersensitivity reactions have been reported. Permanently discontinue SYNAGIS and administer appropriate medication if such reactions occur.

Coagulation Disorders: SYNAGIS should be given with caution to children with thrombocytopenia or any coagulation disorder.

RSV Diagnostic Test Interference: Palivizumab may interfere with immunological-based RSV diagnostic tests, such as some antigen detection-based assays.

Adverse Reactions

Serious Adverse Reactions: The most common serious adverse reactions occurring with SYNAGIS are anaphylaxis and other acute hypersensitivity reactions.

Most Common Adverse Reactions: The most common adverse reactions are fever and rash.

Postmarketing Experience: Severe thrombocytopenia and injection site reactions have been identified during post approval use of SYNAGIS. 
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These are not all the possible risks associated with SYNAGIS. 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.

For Statutory Pricing Disclosure, visit synagishcp.com/wac-pricing.