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Revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous for the prevention of respiratory syncytial virus infections.

Abstract
Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous (RSV-IGIV) are licensed by the Food and Drug Administration for use in preventing severe respiratory syncytial virus (RSV) infections in high-risk infants, children younger than 24 months with chronic lung disease (formerly called bronchopulmonary dysplasia), and certain preterm infants. This report summarizes the clinical trial information on which the guidance in the accompanying policy statement for administering RSV prophylaxis to certain children with a history of preterm birth, chronic lung disease, or congenital heart disease is based. On the basis of results of a recently completed clinical trial, palivizumab is appropriate for infants and young children with hemodynamically significant congenital heart disease. RSV-IGIV should not be used in children with hemodynamically significant heart disease. Palivizumab is preferred for most high-risk infants and children because of ease of intramuscular administration. Monthly administration of palivizumab during the RSV season results in a 45% to 55% decrease in the rate of hospitalization attributable to RSV. Because of the large number of infants born after 32 to 35 weeks' gestation and because of the high cost, immunoprophylaxis should be considered for this category of preterm infants only if 2 or more risk factors are present.
AuthorsH Cody Meissner, Sarah S Long, American Academy of Pediatrics Committee on Infectious Diseases and Committee on Fetus and Newborn
JournalPediatrics (Pediatrics) Vol. 112 Issue 6 Pt 1 Pg. 1447-52 (Dec 2003) ISSN: 1098-4275 [Electronic] United States
PMID14654628 (Publication Type: Technical Report)
Chemical References
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Immunoglobulins, Intravenous
  • respiratory syncytial virus immune globulin intravenous
  • Palivizumab
Topics
  • Antibodies, Monoclonal (administration & dosage, economics, therapeutic use)
  • Antibodies, Monoclonal, Humanized
  • Child
  • Child, Preschool
  • Clinical Trials as Topic
  • Coronary Disease (complications)
  • Cost-Benefit Analysis
  • Humans
  • Immunoglobulins, Intravenous (administration & dosage, economics, therapeutic use)
  • Infant
  • Palivizumab
  • Respiratory Syncytial Virus Infections (economics, prevention & control)
  • Respiratory Syncytial Viruses (immunology)
  • Risk Factors

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