Drug Profile 10.1586/14787210.3.5.719 © 2005 Future Drugs Ltd ISSN 1478-7210 719 www.future-drugs.com Palivizumab in the prophylaxis of respiratory syncytial virus infection Silvia Cardenas, Alexander Auais and Giovanni Piedimonte † † Author for correspondence University of Miami, Departments of Pediatrics, Medicine and Molecular and Cellular Pharmacology, Pediatric Pulmonary Research, 1580 NW 10th Avenue, Room 307 Miami, FL 33136, USA Tel.: +1 305 243 1425 Fax: +1 305 243 6708 gpiedimo@med.miami.edu KEYWORDS: bronchiolitis, bronchopulmonary dysplasia, IVIG, passive immunization, prematurity, prophylaxis, respiratory syncytial virus Respiratory syncytial virus infection continues to be one of the most important health problems in infancy. Active prophylaxis against this infection (i.e., vaccination) is not available. Therefore, protection of high-risk infants is possible only by passive prophylaxis with specific antibodies. Palivizumab (Synagis ® ) and respiratory syncytial virus intravenous immune globulin are licensed by the US Food and Drug Administration for the prevention of severe lower respiratory tract infections caused by respiratory syncytial virus in infants with bronchopulmonary dysplasia, infants with a history of premature birth (≤35 weeks gestational age) and children with hemodynamically significant congenital heart disease. Palivizumab is a humanized monoclonal antibody produced by recombinant DNA technology, directed to an epitope in the A antigenic side of the F-protein of the respiratory syncytial virus. This review discusses the characteristics of this drug in detail. Expert Rev. Anti Infect. Ther. 3(5), 719–726 (2005) Respiratory syncytial virus (RSV) infection continues to be one of the most important health problems in infancy, and the most frequent reason for hospitalization of infants in developed countries [1]. Half of all North- American children are infected during their first RSV season [2,3], and virtually all are infected by the age of 2 years [4]. Approxi- mately 20% of all infants have RSV-associated wheezing in the first year of life, and 2–3% require hospitalization for this illness [5]. It has been estimated that more than 120,000 infants in the USA will be hospitalized annually with RSV infection, with more than 200 deaths as a result of this illness [6,7]. Premature infants, especially those with underlying cardiopulmonary pathology, are at increased risk for severe infection, as are older children and adults with immune deficits or cystic fibrosis (CF) [8,9]. Primary infection does not confer immunity, and reinfection is common. Active prophylaxis against RSV (i.e., vacci- nation) is not available. Therefore, protection of high-risk infants is possible only by passive prophylaxis with specific antibodies. Palivizu- mab (Synagis ® ) and RSV intravenous immune globulin (IVIG) are licensed by the US Food and Drug Administration (FDA) for the prevention of severe lower respiratory tract infections caused by RSV in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age) and children with a hemo- dynamically significant congenital heart disease (CHD). Overview of the market Current literature shows that there is no evidence-based therapy against acute RSV bronchiolitis and the subsequent recurrence of wheezing episodes (FIGURE 1). Ribavirin is the only antiviral agent approved for this indication, but its efficacy is quite contro- versial, as several prospective and retro- spective studies have failed to show a signifi- cant therapeutic effect. This, combined with safety concerns and the technical complexity of delivering small particle aerosols to the distal airways, have dramatically reduced the use of this agent, which is now limited to the management of immunosuppressed patients. The usefulness of racemic bronchodilators is controversial [10,101], and steroids do not affect the acute and long-term clinical outcome significantly, whether administered CONTENTS Overview of the market Introduction to the compound Chemistry Pharmacodynamics Pharmacokinetics & metabolism Clinical efficacy Postmarketing surveillance Safety & tolerability Conclusion Expert commentary Five-year view Key issues References Affiliations For reprint orders, please contact reprints@future-drugs.com