The American Academy of Pediatrics (AAP) has released a policy statement on the revised indications for the use of palivizumab and respiratory syncytial virus immune globulin intravenous (RSV-IGIV) for the prevention of RSV infections. The full statement was published in the December 2003 issue of Pediatrics.
This statement provides revised recommendations for administering RSV prophylaxis to infants and children with congenital heart disease, for identifying infants with a history of preterm birth and chronic lung disease who are most likely to benefit from immunoprophylaxis, and for reducing the risk of RSV exposure and infection in high-risk children.
Palivizumab and RSV-IVIG are licensed by the U.S. Food and Drug Administration for prevention of RSV in high-risk infants, children younger than 24 months with chronic lung disease (formerly called bronchopulmonary dysplasia), and certain preterm infants (35 weeks of gestation). Only palivizumab is indicated for children with hemodynamically significant congenital heart disease. In all instances, immunoprophylaxis should be reserved for infants and children at greatest risk of RSV infection because of the high cost of the intervention.
Palivizumab is administered intramuscularly at a dose of 15 mg per kg. It is packed in 100- and 50-mg vials that must be used within six hours after they have been opened. RSV-IGIV is administered intravenously at a dose of 750 mg per kg (15 mL per kg). Both options are given once a month beginning just before the onset of RSV season, which typically occurs in November but may vary by region. In general, four subsequent monthly doses are sufficient to provide protection during the RSV season. Hospitalized infants at risk for severe RSV infection should receive prophylaxis 48 to 72 hours before discharge and every 30 days until the end of the season.
Palivizumab does not interfere with vaccine administration. For patients receiving RSV-IGIV prophylaxis, immunization with measles-mumps-rubella and varicella vaccines should be deferred for nine months after the last dose. No data exist on the use of RSV-IGIV and the response to hepatitis B vaccine, but there is no reason to expect interference.
The updated AAP recommendations for RSV prophylaxis are as follows:
Palivizumab or RSV-IVIG prophylaxis should be considered for infants and children younger than two years with chronic lung disease who have required medical therapy (i.e., supplemental oxygen, bronchodilator, diuretic or corticosteroid therapy) within six months before the start of RSV season. Palivizumab is preferred for most high-risk children because of its ease of administration, safety, and effectiveness.
Infants born at 32 weeks of gestation or earlier may benefit from RSV prophylaxis even if they do not have chronic lung disease. For these infants, major risk factors to consider include their gestational and chronologic age at the start of the RSV season. Once a child qualifies for initiation of prophylaxis, administration should continue throughout the season and not stop until the child is six or 12 months of age.
Although palivizumab and RSV-IGIV have been shown to decrease the likelihood of hospitalization for infants born between 32 and 35 weeks of gestation, the cost of administering prophylaxis to this large group must be considered carefully. Prophylaxis should be considered for these infants if two or more risk factors (i.e., child care attendance, school-aged siblings, exposure to environmental air pollutants, congenital abnormalities of the airways, or severe neuromuscular disease) are present. High-risk infants never should be exposed to tobacco smoke. Participation in child care should be restricted during the RSV season if possible. All high-risk infants and their contacts should be immunized against influenza beginning at six months of age.
Prophylaxis against RSV should be initiated just before the onset of the season (beginning of November) and stopped at the end of the season (beginning of March).
Children who are 24 months or younger with hemo-dynamically significant cyanotic and acyanotic congenital heart disease will benefit from five monthly intramuscular injections of palivizumab (15 mg per kg). The following groups are not at increased risk for RSV infection and generally should not receive prophylaxis: infants and children with hemodynamically insignificant heart disease, infants with lesions adequately corrected by surgery unless they continue to require medication for congestive heart failure, and infants with mild cardiomyopathy who are not receiving medical therapy. RSV-IVIG is contraindicated in children with cyanotic congenital heart disease.
Palivizumab and RSV-IGIV have not been evaluated in randomized trials in immunocompromised children, but these patients may benefit from prophylaxis.
Neither palivizumab nor RSV-IGIV is licensed for treatment of RSV disease because they are not effective for this indication.
Limited evidence suggests that some patients with cystic fibrosis may be at increased risk for RSV infection, but there are insufficient data to determine the effectiveness of palivizumab in this population.
If a patient who is receiving immunoprophylaxis has a breakthrough RSV infection, prophylaxis should continue through the RSV season.
Recommendations cannot be made about the use of palivizumab to prevent nosocomial RSV disease.