Patient
Information
Synagis®
(palivizumab) for Prevention of
RSV Infection
RSV is a type of virus that causes lung infections. In
most people, an RSV infection may seem no worse than a bad cold,
but in some children, particularly infants born prematurely, an
infection with RSV can be quite severe. Although there is no
vaccine for RSV, there is a treatment of monthly injections with
antibodies (Synagis
or palivizumab) that seems to benefit infants born
prematurely, particularly those with chronic lung problems.
Although it is apparent that infants with certain types of
congenital heart diseases also have a much rougher time with RSV
infections, it has not been conclusively shown that giving Synagis
benefits them in the same way. For this reason, the American
Academy of Pediatrics has not recommended using Synagis for
children with heart disease unless they are also premature.
Background: The American Academy of
Pediatrics and a leading group of academic physicians specializing
in pediatric respiratory diseases have published two series of
recommendations for using Synagis. The following is a combined
summary of these two statements.
Patients who meet the following criteria should be considered
candidates for SYNAGIS®:
- Infant or child younger than two years of age with chronic
lung disease (CLD) who has required medical therapy for CLD within
6 months before the anticipated RSV season.
- Infants born at 32 weeks of gestation or earlier without CLD
or who do not meet the criteria in the previous condition may also
benefit from RSV prophylaxis. Major risk factors to consider are
gestational age and chronological age at the start of RSV season.
- Infants born at 28 weeks gestation or earlier may benefit
from prophylaxis up to 12 months of age.
- Infants born at 29 to 32 weeks gestation may benefit from
prophylaxis up to 6 months of age.
For patients born between 32 and 35 weeks without CLD, the use of
palivizumab should be reserved for those infants who are less than 6
months of age at the start of RSV season, with additional risk
factors.
These factors include other underlying conditions which may
predispose the patient to respiratory complications:
- Neurologic disease in very low birth weight infants
- A number of school age siblings or crowding in the home
- Multiple births
- Child care center attendance
- Exposure to tobacco smoke in the home
- Anticipated cardiac surgery
- Distance to and availability of hospital care for severe
respiratory illness.
Patients who have CLD, are premature, or have both conditions, who
meet the criteria in recommendations 1 and 2, and who also have
asymptomatic acyanotic congenital heart disease may benefit from
prophylaxis.
Although specific recommendations for immunocompromised patients
cannot be made, children with severe immunodeficiencies may benefit
from prophylaxis.
American Academy of Pediatrics.
Prevention of respiratory syncytial virus infections: Indications
for the use of palivizumab and update on the use of RSV-IGIV.
Pediatrics 1998;102(5):1211-1216.
Meissner HC, Welliver RC, Chartrand SA et al. Immunoprophylaxis with
palivizumab, a humanized respiratory syncytial virus monoclonal
antibody for prevention of respiratory syncytial virus infection in
high risk infants: a consensus opinion. Pediatr Infect Dis J l999;
18:223-31.
The Blue Cross Blue Shield Guidelines
for the use of Synagis can be found here
or at http://www.bluecrossma.com/common/en_US/medical_policies/422%20RSV%20Immunoprophylaxis%20prn.pdf.
SYNAGIS is a registered trademark of MedImmune, Inc.
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