infants at highest risk of RSV

Highest-risk RSV Patients

Risk of hospitalization for severe RSV disease is greatest in certain vulnerable populations

infants at highest risk RSV

Interrupted lung development and reduced serum antibody levels1,2

Preterm infants

Very Preterm Infants

Up to a 20x greater rate of RSV hospitalization3

Infant with breathing mask

BPD/CLDP

5x greater rate of RSV hospitalization3

Infant with HS-CHD

HS-CHD

proven RSV protection Icon

SYNAGIS® has more than 25 years of real-world evidence 

and proven protection* against severe RSV disease in the most vulnerable populations4

*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).5

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

REFERENCES: 1. 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. 2. Yeung CY, Hobbs JR. Serum-gamma-G-globulin level in normal premature, post mature, and “small-for-dates” newborn babies. Lancet. 1968;1(7553):1167-1170. 3. 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. 4. SYNAGIS (palivizumab) [prescribing information]. Waltham, MA: Sobi, Inc. 2021. 5. 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.
 

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

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 Colorado prescribers, visit synagishcp.com/wac-pricing.