infants at highest risk of RSV

2024 National Perinatal Association (NPA) Guidelines

2024-2025 RSV Season | Birthday Guide

Infants at highest risk RSV

Select the month RSV season starts in your region.

Help to identify patients in your practice at highest risk for severe RSV disease this season.

Identify any of the 3

NPA guidelines support SYNAGIS® use in any of these high-risk RSV patient groups1:

 
Criteria
Birthday reference

Premature

<28 0/7 wGA and <12 months CA* at the start of RSV season†

Born after  

28 0/7 to 32 0/7 wGA and <6 months CA at the start of RSV season

Born after  

32 1/7 to 35 6/7 wGA and <6 months CA at the start of RSV season, with significant provider-identified risk factors

Born after  

CHD

Hemodynamically significant:

<24 months CA at the start of RSV season, unless cardiology waiver obtained

Born after  

BPD

<24 months CA at the start of RSV season, and with medical management required within 6 months

Born after  

*6 to <12 months of age is outside the approved SYNAGIS Indication. 

†An infant may receive 5 or more monthly doses of SYNAGIS during the RSV season. RSV seasonal onset and duration can vary by year and geographic region. Year-round activity has been reported in Florida and Puerto Rico.2-6

Patients should be evaluated based on the independent clinical judgment of the healthcare professional, and applicable risk factors for appropriate patients should be documented.

This form is intended for use in assessing children for risk of acquiring severe RSV disease. This form has been provided as a guide only and is not intended to be a substitute for or an influence on the independent medical judgment of the healthcare professional. If evaluating in the off-season, assess risk factors again at the beginning of the RSV season as the presence of risk factors may change. The patient assessment criteria are based on 2018 National Perinatal Association guidelines and a June RSV season start.

BPD=bronchopulmonary dysplasia; CA=chronological age; CHD=congenital heart disease; RSV=respiratory syncytial virus; wGA=weeks gestational age. 

REFERENCES: 1. Goldstein M, Hopkins B, Kadri M, et al. National Perinatal Association 2024 respiratory syncytial virus (RSV) prevention clinical practice guideline: clinical presentation, prevention strategies, and social impacts in children: an evidence-based interdisciplinary collaboration. Neonatology Today. 2024;19(1):9-38. 2. SYNAGIS (palivizumab) [prescribing information]. Waltham, MA: Sobi, Inc. 2021. 3. Respiratory syncytial virus infection (RSV): RSV surveillance & research. Centers for Disease Control and Prevention. Reviewed July 17, 2023. Accessed October 28, 2023. https://www.cdc.gov/rsv/research/index.html 4. Centers for Disease Control and Prevention. Brief report: respiratory syncytial virus activity—United States, July 2012–June 2014. MMWR Morb Mortal Wkly Rep. 2014;63(48):1133-1136. 5. Mullins JA, Lamonte AC, Bresee JS, Anderson LJ. Substantial variability in community respiratory syncytial virus season timing. Pediatr Infect Dis J. 2003;22(10):857-862. 6. Molinari Such M, García I, García L, et al. Respiratory syncytial virus-related bronchiolitis in Puerto Rico. P R Health Sci J. 2005;24(2):137-140. 

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

IMPORTANT SAFETY INFORMATION

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.

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.

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.

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

 

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 WAC pricing, visit synagishcp.com/wac-pricing.