Na. Halsey et al., PREVENTION OF RESPIRATORY SYNCYTIAL VIRUS-INFECTIONS - INDICATIONS FOR THE USE OF PALIVIZUMAB AND UPDATE ON THE USE OF RSV-IGIV, Pediatrics (Evanston), 102(5), 1998, pp. 1211-1216
The Food and Drug Administration recently approved the use of palivizu
mab (pale-vizhu-mab), an intramuscularly administered monoclonal antib
ody preparation. Recommendations for its use are based on a large, ran
domized study demonstrating a 55% reduction in the risk of hospitaliza
tion attributable to respiratory syncytial virus (RSV) infections in h
igh-risk pediatric patients. Infants and children with chronic lung di
sease (CLD), formerly designated bronchopulmonary dysplasia, as well a
s 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 intr
avenous (RSV-IGIV) are available for protecting high-risk children aga
inst serious complications from RSV infections. Palivizumab is preferr
ed for most high-risk children because of ease of administration (intr
amuscular), lack of interference with measles-mumps-rubella vaccine an
d varicella vaccine, and lack of complications associated with intrave
nous administration of human immune globulin products. RSV-IGIV, howev
er, provides additional protection against other respiratory viral ill
nesses and may be preferred for selected high-risk children including
those receiving replacement intravenous immune globulin because of und
erlying immune deficiency or human immunodeficiency virus infection. F
or premature infants about to be discharged from hospitals during the
RSV season, physicians could consider administering RSV-IGIV for the f
irst month of prophylaxis. Most of the guidelines from the American Ac
ademy of Pediatrics for the selection of infants and children to recei
ve RSV-prophylaxis remain unchanged. Palivizumab has been shown to pro
vide benefit for infants who were 32 to 35 weeks of gestation at birth
. RSV-IGIV is contraindicated and palivizumab is not recommended for c
hildren with cyanotic congenital heart disease. The number of patients
with adverse events judged to be related to palivizumab was similar t
o that of the placebo group (11% vs 10%, respectively); discontinuatio
n of injections for adverse events related to palivizumab was rare.