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Synagis Efficacy & Safety

Research

Research has shown that Synagis can reduce RSV-related hospitalizations.

Synagis® (palivizumab) Pivotal Trial

The IMpact-RSV Study Group. Palivizumab, a humanized RSV monoclonal antibody, reduces hospitalization from RSV infection in high-risk infants.

Overview: IMpact-RSV was a randomized, multicenter, double-blind, placebo-controlled phase 3 trial in which 1502 patients were randomized (n=1002 palivizumab; n=500 placebo) to receive five monthly injections of either placebo or palivizumab 15 mg/kg through the respiratory syncytial virus (RSV) season.

Results: The two groups were well matched. Results showed that regular monthly doses of 15 mg/kg of Synagis® (palivizumab) reduced the incidence of RSV-related hospitalizations by 55% (10.6 % vs. 4.8%). Ninety-nine percent of the patients completed this trial. Overall, 94% of the placebo group and 92% of the palivizumab group received all 5 injections, and more than 95% of both groups received at least 4 injections.

IMpact Trial Results:

Synagis Decreased RSV-Related Hospitalization Rates in Premature Infants With and Without CLD*1,2

The IMpact Study - Primary endpoint
*CLD = chronic lung disease.

Synagis Also Significantly Decreased RSV-Related Hospitalization Rates in Premature Infants Without CLD1,2

The IMpact Study - Secondary endpoint

Adverse events:

  • No significant differences were observed in reported adverse events between the Synagis® (palivizumab) and placebo groups.
  • Discontinuation due to related adverse events was 0.3%.

Most Frequently Reported Adverse Events Potentially Related to Study Drug.1

Adverse Events

* Reported events in at least 1% of children in 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.

IMpact-RSV Study: Adverse Events

  • The number of children reporting adverse events judged by the blinded investigator to be related to the study drug was similar in the placebo (10%) and the Synagis® (11%) groups.
  • No statistically significant differences were found in related events by body system.
  • Discontinuation of injections for adverse events related to Synagis was rare (0.3%).
  • Overall, 1.8% of the placebo group and 2.7% of the Synagis group reported adverse events related to the injection site.
  • The adverse events seen on this slide represent all events reported in at least 1% of children in the palivizumab group. Other adverse events were non-significant

Synagis Reduced RSV-Related Hospitalizations in Children With CHD3

Graph for RSV hospitalization rate
  • Serious adverse events occurred in 55.4% of palivizumab recipients and 63.1% of placebo recipients (p < 0.005); None were related to palivizumab.

Most Frequently Reported Adverse Events Potentially Related to Study Drug*3

Most Frequently Reported Adverse Events Potentially Related to Study Drug*(3)

Important Safety Information

Synagis® (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease and is administered by intramuscular injection. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). Synagis has been used in more than one million children in the U.S. since its introduction in 1998. The first dose of Synagis should be administered prior to commencement of the RSV season. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season.

Synagis should not be used in pediatric patients with a history of severe prior reaction to Synagis or its components. Cases of anaphylaxis were reported following re-exposure to Synagis and severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on re-administration of Synagis. In post-marketing reports, cases of severe thrombocytopenia (platelet count <50,000/microliter) have been reported.

In clinical trials, the most common adverse events occurring at least 1% more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever, and rhinitis. Cyanosis and arrhythmia were seen in children with CHD. There have also been post-marketing reports of injection site reactions.

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References

  1. The IMpact-RSV Study Group. Pediatrics. 1998;102:531-537.
  2. Data on file at MedImmune, LLC
  3. Feltes T, Cabalka A, Meissner C, et al. J Pediatr. 2003; 143:532-540.
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