Open AccessSAFETY AND TOLERANCE OF PALIVIZUMAB ADMINISTRATION IN A LARGE NORTHERN HEMISPHERE TRIAL
Author(s) -
Jessie R. Groothuis
Publication year - 2001
Publication title -
the pediatric infectious disease journal/the pediatric infectious disease journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.028
H-Index - 140
eISSN - 1532-0987
pISSN - 0891-3668
DOI - 10.1097/00006454-200106000-00018
Subject(s) - palivizumab , bronchopulmonary dysplasia , tolerability , bronchiolitis , medicine , adverse effect , pediatrics , respiratory system , gestational age , biology , pregnancy , genetics
An Expanded Access Study was conducted to collect additional safety data on palivizumab. Preterm infants with or without bronchopulmonary dysplasia received palivizumab every 30 days during the respiratory syncytial virus season. Adverse events were low (6.9%) in the 565 subjects. Serious adverse events included hospitalization and 1 case of respiratory syncytial virus bronchiolitis not requiring hospitalization. This study reaffirms the safety and tolerability of palivizumab.