Safety and pharmacokinetics of palivizumab, administered in infants with a history of prematurity or chronic lung disease

• Published in: Japanese Journal of Chemotherapy Vol. 50; no. 4; pp. 215 - 222
• Main Author: Takeuchi, Yoshinao
• Format: Journal Article
• Language: Japanese
• Published: Japanese Society of Chemotherapy 2002; 公益社団法人 日本化学療法学会
• Subjects: palivizumab; respiratory syncytial virus; 早産児; 気管支肺異形成症; 血清中濃度
• ISSN: 1340-7007; 1884-5886
• DOI: 10.11250/chemotherapy1995.50.215

RSV lower respiratory tract illness (RSV-LRI) is often severe in preterm infants and in those with chronic lung disease (CLD), also known as bronchopulmonary dysplasia (BPD). Palivizumab is a humanized monoclonal antibody developed to prevent serious RSV illness in such infants. In this study, palivizumab was given intramuscularly at 15mg/kg every 30 days for up to 2 doses to 31 infants born prematurely at<35 weeks of gestation who were<6 months old or infants with CLD who were<24 months old. Palivizumab serum concentrations were measured (30μg/mL is the effective concentration) and its safety and immunogenicity evaluated. Mean serum concentration 30 days after the first injection was 50.5±17.5μg/mL and 76±17.6μg/mL after the second, respectively. The number of infants with palivizumab serum concentrations exceeding 30μg/mL was 26/31 (83.9%) following the first infusion and 30/31 (96.8%) following the second. Adverse events included the respiratory system in 9 subjects (17 cases), fever in 6 subjects (9 cases), digestive system in 4 subjects (8 cases), and skin in 6 subjects (6 cases). One subject developed diarrhea and dehydration and was hospitalized. Laboratory abnormalities (1 subject each) included protein in urine, increased AST, and increased AST-EALT. None of these adverse events was judged by investigators to be related to palivizumab. One subject reportedly had mild RSV illness (nasal discharge and obstruction) but was not hospitalized. No antipalivizumab antibodies were observed in any subject. Palivizumab appears safe, is not immunogenic, and may inhibit serious RSV LRI in preterm infants and in those with CLD.