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.