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IMpact study: significantly decreased RSV-related hospitalization rates
compared to placebo1

IMpact study: Decreased RSV-related hospitalization rates compared to placebo in all patients IMpact study: Decreased RSV-related hospitalization rates compared to placebo in patients with BPD IMpact study: Decreased RSV-related hospitalization rates compared to placebo in patients without BPD

STUDY DESIGN: A multicenter, randomized, placebo-controlled trial in infants born at ≤35 weeks GA or children with BPD (≤24 months of age) randomized (N=1,502) to receive 1 injection of Synagis (15 mg/kg) (n=1,002) or equivalent volume of placebo (n=500) every 30 days for a total
of 5 doses.1

BPD = bronchopulmonary dysplasia

Significant reductions in rate of RSV-related hospitalizations in all premature infant age groupings were demonstrated with Synagis compared to placebo1,2*

*Premature infants without BPD: <32 weeks GA: 72% reduction (1.8% vs. 6.5%), P=0.027; 32–35 weeks GA: 82% reduction (1.8% vs. 10%), P=0.0013

Secondary endpoints in all patients1

RSV-related hospitalization – Secondary Endpoints in all Patients

There was no statistically significant difference in incidence (0.2% vs. 0.7%) or total number of days per 100 children (1.7 days vs. 8.4 days) of mechanical ventilation, incidence (14% vs. 13%) or total days per 100 children (118 days vs. 88 days) of hospitalization for non-RSV respiratory illness, or incidence of otitis media (40% vs. 42%)1

Feltes et al trial: Synagis significantly reduced RSV-related hospitalization rates in infants and children with CHD4

RSV-related hospitalizations may be preventable for infants and children with hemodynamically significant CHD4

Feltes et al trial: Synagis significantly reduced RSV-related hospitalization rates in infants and children with CHD Feltes et al trial: Synagis significantly reduced RSV-related hospitalization rates in infants and children with CHD

STUDY DESIGN: A randomized, double-blind, placebo-controlled trial including 1,287 children with hemodynamically significant CHD randomly assigned 1:1 to receive 5 monthly intramuscular injections of 15 mg/kg Synagis or placebo.4

Synagis cardiac study secondary endpoints

Synagis cardiac study secondary endpoints

There was no statistically significant difference in incidence of RSV-related intensive care (3.7% for placebo vs. 2.0% for Synagis), days of RSV-related intensive care unit stay per 100 children (71.2 days for placebo vs. 15.9 days for Synagis), incidence of RSV-related mechanical ventilation (2.2% for placebo vs. 1.3% for Synagis), or days of RSV-related mechanical ventilation per 100 children (54.7 days for placebo vs. 6.5 days for Synagis).4

Important Safety Information

Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease. Safety and efficacy were established in children with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). The recommended dose of Synagis is 15 mg/kg of body weight given monthly by intramuscular injection. The first dose of Synagis should be administered prior to commencement of the RSV season and the remaining doses should be administered monthly throughout the RSV season. Children who develop an RSV infection should continue to receive monthly doses throughout the RSV season.

The efficacy of Synagis at doses less than 15 mg/kg, or of dosing less frequently than monthly throughout the RSV season, has not been established.

Synagis is contraindicated in children who have had a previous significant hypersensitivity reaction to Synagis. Cases of anaphylaxis and anaphylactic shock, including fatal cases, have been reported following initial exposure or re-exposure to Synagis. Other acute hypersensitivity reactions, which may be severe, have also been reported on initial exposure or re-exposure to Synagis. The relationship between these reactions and the development of antibodies to Synagis is unknown. If a significant hypersensitivity reaction occurs with Synagis, its use should be permanently discontinued. If a mild hypersensitivity reaction occurs, clinical judgment should be used regarding cautious readministration of Synagis. As with any intramuscular injection, Synagis should be given with caution to children with thrombocytopenia or any coagulation disorder. Palivizumab may interfere with immunological-based RSV diagnostic tests, such as some antigen detection-based assays.

Adverse reactions occurring greater than or equal to 10% and at least 1% more frequently than placebo are fever and rash. In post-marketing reports, cases of severe thrombocytopenia (platelet count <50,000/microliter) and injection site reactions have been reported.

Please see full Prescribing Information for Synagis, including Patient Information.