RSV Overview
Disease Burden
RSV is a major human pathogen and the leading cause of infant hospitalization in the US.1
It is also the leading cause of lower respiratory infection in infants and small children. Approximately two-thirds
of all infants are infected with RSV during their first year of life, and infection
is virtually universal by the age of two years.2,3 Reinfection is
also common, because infection does not provide long-lasting immunity.
Premature Infants Are At High Risk for Severe Hospital Outcomes From RSV Disease4
Once Hospitalized With RSV Disease, 33-35 Week GA Infants Have Significantly Worse Outcomes vs Full-Term
Infants
†ICU = intensive care unit.
*LOS
= length of stay.
‡Statistically significant difference from
full-term infants (Duncan multiple range test).
§P
values derived from comparison of 4 GA groups (≤32 weeks' GA, 33-35 weeks'
GA, 36 weeks' GA, ≥37 weeks' GA).
A retrospective, multicenter study by Horn and Smout measured the severity of illness in 304 infants
≤1 year of age who were admitted to the hospital with confirmed RSV disease from April 1995 to September
1996.
In the same study4:
Both ≤32 week GA and 33-35
week GA infant groups had greater use of hospital resources and poorer
hospital outcomes compared to full-term infants.
Each year, respiratory syncytial virus (RSV) is responsible for up to
125,000 hospitalizations in infants under one year of age in the United States.5-7 Among
hospitalized infants with heart and chronic lung disease, the RSV mortality
rate may be as high as 3.5%.8 Up to half of all pediatric
admissions for bronchiolitis and 25% of admissions for pneumonia are due to
RSV.9
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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