Biotechnology Healthcare - July/August 2008 - (Page CB7)

Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child. 1986;140:543–546. Horn SD, Smout RJ. Effect of prematurity on respiratory syncytial virus hospital resource use and outcomes. J Pediatr. 2003;143(5):S133–S141. Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr. 2003a;143(5):S127–S132. Leader S, Yang H, DeVincenzo J, et al. Time and out-of-pocket costs associated with respiratory synctial virus hospitalization of infants. Value in Health. 2003b;6(2):100–106. Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. Pediatr Infect Dis J. 2002;21:629–632 . Light M. Respiratory syncytial virus seasonality in southeast Florida: Results from three area hospitals caring for children. Pediatr Infect Dis J. 2007;26(11):S55–S59. McLaurin KK, Leader S. Growing impact of RSV hospitalizations among infants in the US, 1997-2002. Abstract 936. Presented at: Pediatric Academic Societies Annual Meeting, May 14-17, 2005; Washington, D.C. MedImmune, LLC, Gaithersburg, Md. Data on File. 2008. Mullins JA, Lamonte AC, Bresee JS, Anderson LJ. Substantial variability in community respiratory syncytial virus season timing. Pediatr Infect Dis J. 2003;22(10):857–862. Panozzo CA, Fowlkes AL, Anderson LJ. Variation in timing of respiratory syncytial virus outbreaks: Lessons from national surveillance. Pediatr Infect Dis J. 2007;26(11):S41–S45. Peret TCT, Hall CB, Hammond GW, et al. Circulation patterns of group A and B human respiratory syncytial virus genotypes in 5 communities in North America. J Infect Dis. 2000;181:1891–1896. Peret TCT, Hall CB, Schnabel KC, et al. Circulation patterns of genetically distinct group A and B strains of human respiratory syncytial virus in a community. J Gen Virol. 1998;79:2221–2229. Shay DK, Holman RC, Newman RD, et al. Bronchiolitis-associated hospitalizations among U S children, 1980–1996. JAMA. 1999;282(15):1440–1446. Shay DK, Holman RC, Roosevelt GE, et al. Bronchiolitis-associated mortality and estimates of respiratory syncytial virus-associated deaths among US children, 1979–1997. J Infect Dis. 2001;183:16–22. Important Safety Information Synagis® (palivizumab) is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease and is administered by intramuscular injection. Safety and efficacy were established in infants with bronchopulmonary dysplasia (BPD), infants with a history of premature birth (≤35 weeks gestational age), and children with hemodynamically significant congenital heart disease (CHD). Synagis has been used in more than one million children in the U.S. since its introduction in 1998. The first dose of Synagis should be administered prior to commencement of the RSV season. Patients, including those who develop an RSV infection, should continue to receive monthly doses throughout the season. Very rare cases (<1 per 100,000 patients) of anaphylaxis and rare (<1 per 1,000 patients) hypersensitivity reactions have been reported with Synagis. Cases of anaphylaxis were reported following re-exposure to Synagis and rare severe hypersensitivity reactions occurred on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reaction occurs, caution should be used on re-administration of Synagis. In post-marketing reports, very rare cases (<1 case per 100,000 patients) of severe thrombocytopenia (platelet count <50,000/microliter) have been reported. In clinical trials, the most common adverse events occurring at least 1% more frequently in Synagis-treated patients than controls were upper respiratory infection, otitis media, fever, and rhinitis. Cyanosis and arrhythmia were seen in children with CHD. There have also been post-marketing reports of injection site reactions. Please see Full Prescribing Information on page 8. 7

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Biotechnology Healthcare - July/August 2008 Openers Contents Editorial/David B. Nash, MD, MBA Drug Track Health Plan Confidential Rheumatoid Arthritis A Decade of Trial, Error, False Starts, and Hope What Path Will Comparative Effectiveness Research Take? RA Therapies in Development: A New Generation of Relief Assessing the Full Impact of RA on Employers and Payers Stem Cells: Health Insurance You Can Bank On Specialty Pharmacy Employer to Employer Personalized Medicine Trends Clinical Briefs

Biotechnology Healthcare - July/August 2008

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