PEDIATRICS Vol. 102 No. 5 November 1998, pp. 1211-1216
AMERICAN ACADEMY OF PEDIATRICS:
Prevention of Respiratory Syncytial Virus Infections: Indications
for the Use of Palivizumab and Update on the Use of RSV-IGIV
The Food and Drug Administration recently approved
the use of palivizumab (pal
-vizh
-mäb), an
intramuscularly administered monoclonal antibody preparation.
Recommendations for its use are based on a large, randomized study
demonstrating a 55% reduction in the risk of hospitalization
attributable to respiratory syncytial virus (RSV) infections in
high-risk pediatric patients. Infants and children with chronic lung
disease (CLD), formerly designated bronchopulmonary dysplasia, as well
as prematurely born infants without CLD experienced a reduced number of
hospitalizations while receiving palivizumab compared with a placebo.
Both palivizumab and respiratory syncytial virus immune globulin
intravenous (RSV-IGIV) are available for protecting high-risk children
against serious complications from RSV infections. Palivizumab is
preferred for most high-risk children because of ease of administration
(intramuscular), lack of interference with measles-mumps-rubella
vaccine and varicella vaccine, and lack of complications associated
with intravenous administration of human immune globulin products.
RSV-IGIV, however, provides additional protection against other
respiratory viral illnesses and may be preferred for selected
high-risk children including those receiving replacement
intravenous immune globulin because of underlying immune deficiency or
human immuno-deficiency virus infection. For premature infants
about to be discharged from hospitals during the RSV season, physicians
could consider administering RSV-IGIV for the first month of
prophylaxis.
Most of the guidelines from the American Academy of Pediatrics for the selection of infants and children to receive RSV-prophylaxis remain unchanged. Palivizumab has been shown to provide benefit for infants who were 32 to 35 weeks of gestation at birth. RSV-IGIV is contraindicated and palivizumab is not recommended for children with cyanotic congenital heart disease. The number of patients with adverse events judged to be related to palivizumab was similar to that of the placebo group (11% vs 10%, respectively); discontinuation of injections for adverse events related to palivizumab was rare.
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The following policy statement is a revision:
- Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections
Pediatrics 112: 1442-1446.[Full Text]
The following policy statement has been revised:
- Respiratory Syncytial Virus Immune Globulin Intravenous: Indications for Use
- and
Pediatrics 99: 645-650.[Full Text]
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