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AAP releases guidelines on the pediatric use of new RSV drug

Palivizumab provides an alternative approach to the prevention of RSV infections in high-risk infants.

[Indications for usage]

[Your turn]

December 1998

ELK GROVE VILLAGE, Ill. - The American Academy of Pediatrics (AAP) recently released guidelines for the prevention of respiratory syncytial virus (RSV) and indications for the use of the newest RSV treatment.

In June, the Food and Drug Administration (FDA) approved the use of palivizumab (Synagis, MedImmune Inc.) an intramuscularly administered monoclonal antibody preparation directed against the F glycoprotein of RSV. The guidelines were drafted by the AAP Committee on Infectious Diseases and the Committee on Fetus and the Newborn.

Indications for usage

While 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. It is easier to administer and there is a lack of interference with measles-mumps-rubella and varicella vaccines. In addition, there is also a lack of complications associated with intravenous administration of human immune globulin products, according to the AAP.

Choosing which product to use will depend on age, availability of intravenous access, cost and other factors. However, the AAP guidelines also state that RSV-IGIV provides additional protection against other respiratory viral illness and may be preferred for selected high-risk children including those receiving replacement intravenous immune globulin because of underlying immune deficiency.

Physicians should also consider administering RSV-IGIV for the first month of prophylaxis to premature infants who are about to leave the hospital during RSV season. Palivizumab is not recommended - and RSV-IGIV is contraindicated - for use in children with cyanotic congenital heart disease.

There is no peer-reviewed data available on the cost-benefit analysis for palivizumab, and only a limited amount of data available for RSV-IGIV. However, the cost-benefit analyses of RSV-IGIV did not demonstrate an overall savings in hospitalization considering the costs of therapy for all at-risk children.

AAP Recommendations on the Use of Palivizumab

Palivizumab or RSV-IGIV prophylaxis should be considered for infants and children younger than 2 years with chronic lung disease (CLD) who have required medical therapy for their CLD within six 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 first recommendation may benefit from RSV prophylaxis. In these infants, major risk factors to consider are gestational age and chronological age at the start of the RSV season. Given the large number of patients born between 32-25 weeks and the cost of the drug, the use of palivizumab in this population should be reserved for those infants with additional risk factors until more data are available. Palivizumab and RSV-IGIV are not licensed by the FDA for patients with congenital heart disease (CHD). Available data indicate that RSV-IGIV is contraindicated in patients with cyanotic CHD. However, patients with CLD, who are premature or both, who meet the criteria in the first and second recommendations. Palivizumab or RSV-IGIV prophylaxis has not been evaluated in randomized trials in immunocompromised children. Although specific recommendations for immunocompromised patients cannot be made, children with severe immunodeficiencies may benefit from prophylaxis. RSV prophylaxis should be initiated at the onset of the RSV season and terminated at the end of the RSV season. In most areas of the United States, the usual time for the beginning of RSV outbreaks is October to December, and termination is March to May, but regional differences occur. The onset of RSV infection occurs earlier in southern states than in northern states. The AAP recommends practitioners contact their health departments and/or diagnostic virology laboratories in their geographic areas to determine the optimal time to begin administration. RSV is transmitted in the hospital setting and causes serious disease in high-risk infants. In high-risk patients, the major means to prevent RSV disease is strict observance of infection control practices, including the use of rapid means to identify and cohort RSV-infected infants. The guidelines for modification of immunizations after RSV-IGIV have not changed. Palivizumab does not interfere with the response to vaccines.

For your information:

• AAP Committee on Infectious Diseases and Committee on Fetus and Newborn. Prevention of respiratory syncytial virus infections: indications for the use of palivizumab and update on the use of RSV-IVIG. Pediatrics 1998;5:1211-1216.

Your turn

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