infants at highest risk of RSV

BPD/CLDP and RSV

SYNAGIS® reduces RSV hospitalizations and the severity of those hospitalizations among children with BPD1,2

BPD CAN COMPROMISE ALREADY FRAGILE PULMONARY FUNCTION AND DAMAGE IMMATURE LUNGS3-5

Up to 20x

greater rate of RSV hospitalization vs healthy full-term infants6*

About 1⁄3

of hospitalized children with BPD require mechanical ventilation7†

*The reference group comprised full-term (≥37 wGA) infants without BPD, CHD, or certain other specific medical conditions.6

†In a retrospective review of annual RSV hospitalization rates among 117,695 children using the Kids’ Inpatient Database (KID) from 4100 hospitals between 1997 and 2012 and implementing the ICD-9 diagnostic code (770.7x).7

Infants at highest risk RSV

IN THE PIVOTAL IMpact-RSV TRIAL

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Primary group analysis

SYNAGIS significantly reduced RSV hospitalizations by 

39%

among children with BPD1,2 

(RSVH rate 12.8% with placebo vs 7.9% 
with SYNAGIS; P=0.038)
 

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Primary analysis: 

Preterm infants with and without BPD1,2

Reduced Hospitalizations among children with BPD Graph

Primary group analysis: 

Children ≤24 months of age with BPD1,2

Reduced Hospitalizations among children with BPD Graph 2

Get more info about the IMpact-RSV pivotal trial

Study Design

More than 750 children with bronchopulmonary dysplasia (BPD) were randomized in the IMpact-RSV trial.2

740 preterm infants 
≤35 wGA without BPD

  • 405 very preterm infants <32 wGA
  • 335 preterm infants 32-35 wGA

762 children 
≤24 months of age 
with BPD

A multicenter, randomized, placebo-controlled trial in infants born at ≤35 wGA and ≤6 months of age or children with BPD ≤24 months of age randomized 2:1 to receive 1 injection of palivizumab (15 mg/kg) (n=1002) or an equal volume of placebo (n=500) every 30 days for a total of 5 doses.2
 

Secondary Endpoints

SYNAGIS significantly reduced RSVH severity in preterm infants with and without BPD.2‡

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42%

fewer days of RSV hospitalization

(per 100 children: 62.6 days with placebo vs 36.4 days with SYNAGIS; P<0.001)

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57%

lower rate of ICU admissions

(3.0% with placebo vs 1.3% with SYNAGIS; P=0.026)

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40%

fewer days with increased supplemental oxygen

(per 100 children: 50.6 days with placebo vs 30.3 days with SYNAGIS; P<0.001)

‡The placebo and SYNAGIS groups did not show significant differences in incidence of mechanical ventilation (0.2% vs 0.7%, P=0.280) or total days of mechanical ventilation (1.7 days vs 8.4 days, P=0.210). ICU total days were 12.7 with placebo and 13.3 with SYNAGIS (P=0.023).2
 

Most frequently reported adverse events2§

that were judged to be potentially related to study drug

 

Placebo (n=500)

SYNAGIS (n=1002)

Fever

3.0%

2.8%

Nervousness

2.6%

2.5%

Injection-site reaction

1.6%

2.3%

Diarrhea

0.4%

1.0%

§Reported events in at least 1% of childrenin the palivizumab group are provided along with the corresponding incidence in the placebo group. These represent adverse events reported by the investigator and include those identified by protocol-mandated testing and other clinically indicated evaluations.2
 

CHD=congenital heart disease; CLDP=chronic lung disease of prematurity; ICD-9=International Classification of Diseases, Ninth Revision; ICU=intensive care unit; RSV=respiratory syncytial virus; RSVH=respiratory syncytial virus hospitalization; wGA=weeks gestational age. 

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. 3. Allen J, Zwerdling R, Ehrenkranz R, et al; American Thoracic Society. Statement on the care of the child with chronic lung disease of infancy and childhood. Am J Respir Crit Care Med. 2003;168(3):356-396. 4. Baraldi E, Filippone M. Chronic lung disease after premature birth. N Engl J Med. 2007;357(19):1946-1955. 5. Langston C, Kida K, Reed M, Thurlbeck WM. Human lung growth in late gestation and in the neonate. Am Rev Respir Dis. 1984;129(4):607-613. 6. Boyce TG, Mellen BG, Mitchel EF Jr, Wright PF, Griffin MR. Rates of hospitalization for respiratory syncytial virus infection among children in Medicaid. J Pediatr. 2000;137(6):865-870. 7. Doucette A, Jiang X, Fryzek J, Coalson J, McLaurin K, Ambrose CS. Trends in respiratory syncytial virus and bronchiolitis hospitalization rates in high-risk infants in a United States nationally representative database, 1997-2012. PLoS One. 2016;11(4):e0152208. doi:10.1371/journal.pone.0152208 

All imagery is for illustrative purposes only.
 

ALL INFANTS ARE NOT THE SAME

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.