infants at highest risk of RSV

2014 American Academy of Pediatrics (AAP) Guidance

2023-2024 RSV Season | Birthday Guide

Infants at highest risk RSV

Select the month RSV season starts in your region.

Identify any of the 3

AAP guidance supports SYNAGIS® use in any of these high-risk RSV patient groups1:

 
Criteria
Birthday reference

Premature

≤28 weeks, 6 days gestational age

Born after  

CHD

Hemodynamically significant: (Either of these)

  • Has acyanotic* congenital heart disease and is receiving medication to control congestive heart failure and will require cardiac surgery
  • Has moderate to severe pulmonary hypertension

*Decisions regarding palivizumab prophylaxis for infants with cyanotic heart defects in the first year of life may be made in consultation with a pediatric cardiologist.

Born after  

BPD

<32 wGA and requiring >21% oxygen for at least the first 28 days after birth

Born after  

<32 wGA and requiring >21% oxygen for at least the first 28 days after birth and received medical treatment for BPD/CLDP within 6 months of the start of the second RSV season: (Any 1 of these)

  • Supplemental oxygen 
  • Diuretic 
  • Corticosteroid therapy

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

Born after  

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 2014 American Academy of Pediatrics guidance and a June RSV season start.

BPD=bronchopulmonary dysplasia; CHD=congenital heart disease; CLDP=chronic lung disease of prematurity; RSV=respiratory syncytial virus; wGA=weeks gestational age. 

REFERENCES: 1. American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014;134(2):415-420. 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.