PEDIATRICS Vol. 102 No. 5 November 1998, pp. 1211-1216

AMERICAN ACADEMY OF PEDIATRICS:
Prevention of Respiratory Syncytial Virus Infections: Indications for the Use of Palivizumab and Update on the Use of RSV-IGIV

The Food and Drug Administration recently approved the use of palivizumab (pal-vizh-mäb), an intramuscularly administered monoclonal antibody preparation. Recommendations for its use are based on a large, randomized study demonstrating a 55% reduction in the risk of hospitalization attributable to respiratory syncytial virus (RSV) infections in high-risk pediatric patients. Infants and children with chronic lung disease (CLD), formerly designated bronchopulmonary dysplasia, as well as 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 intravenous (RSV-IGIV) are available for protecting high-risk children against serious complications from RSV infections. Palivizumab is preferred for most high-risk children because of ease of administration (intramuscular), lack of interference with measles-mumps-rubella vaccine and varicella vaccine, and lack of complications associated with intravenous administration of human immune globulin products. RSV-IGIV, however, provides additional protection against other respiratory viral illnesses and may be preferred for selected high-risk children including those receiving replacement intravenous immune globulin because of underlying immune deficiency or human immuno-deficiency virus infection. For premature infants about to be discharged from hospitals during the RSV season, physicians could consider administering RSV-IGIV for the first month of prophylaxis.

Most of the guidelines from the American Academy of Pediatrics for the selection of infants and children to receive RSV-prophylaxis remain unchanged. Palivizumab has been shown to provide benefit for infants who were 32 to 35 weeks of gestation at birth. RSV-IGIV is contraindicated and palivizumab is not recommended for children with cyanotic congenital heart disease. The number of patients with adverse events judged to be related to palivizumab was similar to that of the placebo group (11% vs 10%, respectively); discontinuation of injections for adverse events related to palivizumab was rare.

The following policy statement is a revision:

Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections

Pediatrics 112: 1442-1446. [Full Text]

This article has been cited by other articles:

				N. O. ElHassan, M. E. S. Sorbero, C. B. Hall, T. P. Stevens, and A. W. Dick Cost-effectiveness Analysis of Palivizumab in Premature Infants Without Chronic Lung Disease. Arch Pediatr Adolesc Med, October 1, 2006; 160(10): 1070 - 1076. [Abstract] [Full Text] [PDF]

				C. J. Wang, E. A. McGlynn, R. H. Brook, C. H. Leonard, R. E. Piecuch, S. I. Hsueh, and M. A. Schuster Quality-of-Care Indicators for the Neurodevelopmental Follow-up of Very Low Birth Weight Children: Results of an Expert Panel Process. Pediatrics, June 1, 2006; 117(6): 2080 - 2092. [Abstract] [Full Text] [PDF]

				D. Prais, D. Danino, T. Schonfeld, J. Amir, and for the Israeli RSV Monitoring Group Impact of Palivizumab on Admission to the ICU for Respiratory Syncytial Virus Bronchiolitis: A National Survey Chest, October 1, 2005; 128(4): 2765 - 2771. [Abstract] [Full Text] [PDF]

				P. Manzoni, U. Sala, G. Gomirato, A. Coscia, and C. Fabris Optimal Timing and Dosing Intervals of Palivizumab in Premature Neonates: Still Some Work to Do Pediatrics, May 1, 2005; 115(5): 1439 - 1440. [Full Text] [PDF]

				T Heikkinen, H Valkonen, L Lehtonen, R Vainionpaa, and O Ruuskanen Hospital admission of high risk infants for respiratory syncytial virus infection: implications for palivizumab prophylaxis Arch. Dis. Child. Fetal Neonatal Ed., January 1, 2005; 90(1): F64 - F68. [Abstract] [Full Text] [PDF]

				S. Wegner, J. J. Vann, G. Liu, P. Byrns, C. Cypra, W. Campbell, and A. Stiles Direct Cost Analyses of Palivizumab Treatment in a Cohort of At-Risk Children: Evidence From the North Carolina Medicaid Program Pediatrics, December 1, 2004; 114(6): 1612 - 1619. [Abstract] [Full Text] [PDF]

				K. Hashimoto, B. S. Graham, M. W. Geraci, G. A. FitzGerald, K. Egan, W. Zhou, K. Goleniewska, J. F. O'Neal, J. D. Morrow, R. K. Durbin, et al. Signaling through the Prostaglandin I2 Receptor IP Protects against Respiratory Syncytial Virus-Induced Illness J. Virol., October 1, 2004; 78(19): 10303 - 10309. [Abstract] [Full Text] [PDF]

				A Duppenthaler, R A Ammann, M Gorgievski-Hrisoho, J-P Pfammatter, and C Aebi Low incidence of respiratory syncytial virus hospitalisations in haemodynamically significant congenital heart disease Arch. Dis. Child., October 1, 2004; 89(10): 961 - 965. [Abstract] [Full Text] [PDF]

				K L Brown, G Walker, D J Grant, K Tanner, D A Ridout, L S Shekerdemian, J H Smith, C Davis, R K Firmin, and A P Goldman Predicting outcome in ex-premature infants supported with extracorporeal membrane oxygenation for acute hypoxic respiratory failure Arch. Dis. Child. Fetal Neonatal Ed., September 1, 2004; 89(5): F423 - F427. [Abstract] [Full Text] [PDF]

				T Lacaze-Masmonteil, P Truffert, D Pinquier, P Daoud, G Goldfarb, E Vicaut, and B Fauroux Lower respiratory tract illness and RSV prophylaxis in very premature infants Arch. Dis. Child., June 1, 2004; 89(6): 562 - 567. [Abstract] [Full Text] [PDF]

				A. Mejias, S. Chavez-Bueno, A. M. Rios, J. Saavedra-Lozano, M. Fonseca Aten, J. Hatfield, P. Kapur, A. M. Gomez, H. S. Jafri, and O. Ramilo Anti-Respiratory Syncytial Virus (RSV) Neutralizing Antibody Decreases Lung Inflammation, Airway Obstruction, and Airway Hyperresponsiveness in a Murine RSV Model Antimicrob. Agents Chemother., May 1, 2004; 48(5): 1811 - 1822. [Abstract] [Full Text] [PDF]

				H. C. Meissner, M. B. Rennels, S. S. Long, and L. K. Pickering Immunoprophylaxis With RespiGam Pediatrics, March 1, 2004; 113(3): 629 - 629. [Full Text] [PDF]

				L. Saiman and J. Siegel Infection Control in Cystic Fibrosis Clin. Microbiol. Rev., January 1, 2004; 17(1): 57 - 71. [Abstract] [Full Text] [PDF]

				Committee on Infectious Diseases and Committee on Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections Pediatrics, December 1, 2003; 112(6): 1442 - 1446. [Abstract] [Full Text] [PDF]

				H. C. Meissner, S. S. Long, and Committee on Infectious Diseases, and Committee on Revised Indications for the Use of Palivizumab and Respiratory Syncytial Virus Immune Globulin Intravenous for the Prevention of Respiratory Syncytial Virus Infections Pediatrics, December 1, 2003; 112(6): 1447 - 1452. [Abstract] [Full Text] [PDF]

				S A Deshpande and V Northern The clinical and health economic burden of respiratory syncytial virus disease among children under 2 years of age in a defined geographical area Arch. Dis. Child., December 1, 2003; 88(12): 1065 - 1069. [Abstract] [Full Text] [PDF]

				E. A. Helm, G. E. Cummings, V. Keane, and J. C. King Jr Administration of Palivizumab: A Medical Provider's Perspective Clinical Pediatrics, November 1, 2003; 42(9): 821 - 826. [PDF]

				D. Prais, T. Schonfeld, and J. Amir Admission to the Intensive Care Unit for Respiratory Syncytial Virus Bronchiolitis: A National Survey Before Palivizumab Use Pediatrics, September 1, 2003; 112(3): 548 - 552. [Abstract] [Full Text] [PDF]

				C. A. McCarthy and C. B. Hall Respiratory Syncytial Virus: Concerns and Control Pediatr. Rev., September 1, 2003; 24(9): 301 - 309. [Full Text] [PDF]

				A. Hu, M. Colella, J. S. Tam, R. Rappaport, and S.-M. Cheng Simultaneous Detection, Subgrouping, and Quantitation of Respiratory Syncytial Virus A and B by Real-Time PCR J. Clin. Microbiol., January 1, 2003; 41(1): 149 - 154. [Abstract] [Full Text] [PDF]

				Identify patients who should receive RSV immunoprophylaxis AAP News, November 1, 2002; 21(5): 232 - 233. [Full Text] [PDF]

				S. Kamal-Bahl, J. Doshi, and J. Campbell Economic Analyses of Respiratory Syncytial Virus Immunoprophylaxis in High-Risk Infants: A Systematic Review Arch Pediatr Adolesc Med, October 1, 2002; 156(10): 1034 - 1041. [Abstract] [Full Text] [PDF]

				J. Bockova, K. L. O'Brien, J. Oski, J. Croll, R. Reid, R. C. Weatherholtz, M. Santosham, and R. A. Karron Respiratory Syncytial Virus Infection in Navajo and White Mountain Apache Children Pediatrics, August 1, 2002; 110(2): e20 - 20. [Abstract] [Full Text] [PDF]

				F. F. Nievas and V. Chernick Bronchopulmonary Dysplasia (Chronic Lung Disease of Infancy): An Update for the Pediatrician Clinical Pediatrics, March 1, 2002; 41(2): 77 - 85. [Abstract] [PDF]

				Respiratory Syncytial Virus Activity--United States, 2000-01 Season JAMA, February 20, 2002; 287(7): 834 - 835. [Full Text] [PDF]

				A. Bukreyev, I. M. Belyakov, J. A. Berzofsky, B. R. Murphy, and P. L. Collins Granulocyte-Macrophage Colony-Stimulating Factor Expressed by Recombinant Respiratory Syncytial Virus Attenuates Viral Replication and Increases the Level of Pulmonary Antigen-Presenting Cells J. Virol., December 15, 2001; 75(24): 12128 - 12140. [Abstract] [Full Text] [PDF]

				H. C. Meissner RSV prophylaxis addressed AAP News, November 1, 2001; 19(5): 195 - 203. [Full Text] [PDF]

				H. C. Meissner Uncertainty in the Management of Viral Lower Respiratory Tract Disease Pediatrics, October 1, 2001; 108(4): 1000 - 1003. [Full Text] [PDF]

				C. B. Hall Respiratory Syncytial Virus and Parainfluenza Virus N. Engl. J. Med., June 21, 2001; 344(25): 1917 - 1928. [Full Text] [PDF]

				G. M. Onady Effectiveness of Palivizumab Therapy for RSV AAP Grand Rounds, April 1, 2001; 5(4): 37 - 38. [Full Text] [PDF]

				Respiratory Syncytial Virus Activity--United States, 1999-2000 Season JAMA, January 17, 2001; 285(3): 287 - 288. [Full Text] [PDF]

				and Preventing respiratory syncitial virus BMJ, January 13, 2001; 322(7278): 62 - 63. [Full Text] [PDF]

				M. A. Keller and E. R. Stiehm Passive Immunity in Prevention and Treatment of Infectious Diseases Clin. Microbiol. Rev., October 1, 2000; 13(4): 602 - 614. [Abstract] [Full Text] [PDF]

				L. Brunvand, R. Lindemann, J. Grøgaard;, E. M. Connor, D. Carlin, F. H. Top Jr., and L. E. Weisman Who Shall Not Receive Palivizumab? Pediatrics, October 1, 2000; 106(4): 866 - 866. [Abstract] [Full Text]

				M. Thomas, A. Bedford-Russell, and M. Sharland Hospitalisation for RSV infection in ex-preterm infants---implications for use of RSV immune globulin Arch. Dis. Child., August 1, 2000; 83(2): 122 - 127. [Abstract] [Full Text] [PDF]

				W. LENNEY;, C. CARNEGIE;, and H. MARCOVITCH Palivizumab and RSV prevention Arch. Dis. Child., July 1, 2000; 83(1): 87a - 87. [Full Text]

				S. DESHPANDE; and R M NICHOLL RSV prevention Arch. Dis. Child., January 1, 2000; 82(1): 88 - 88. [Full Text]

				D. K. Shay, R. C. Holman, R. D. Newman, L. L. Liu, J. W. Stout, and L. J. Anderson Bronchiolitis-Associated Hospitalizations Among US Children, 1980-1996 JAMA, October 20, 1999; 282(15): 1440 - 1446. [Abstract] [Full Text] [PDF]

				S. Joffe, G. J. Escobar, S. B. Black, M. A. Armstrong, and T. A. Lieu Rehospitalization for Respiratory Syncytial Virus Among Premature Infants Pediatrics, October 1, 1999; 104(4): 894 - 899. [Abstract] [Full Text]

				G. Suresh;, W. T. Zempsky, N. L. Schechter;, J. L. Fox;, E. M. Connor, D. Carlin, F. H. Top, J. MD, and L. E. Weisman IMpact-RSV Study Group Report Pediatrics, October 1, 1999; 104(4): 993 - 994. [Full Text]

				S. Joffe, G. T. Ray, G. J. Escobar, S. B. Black, and T. A. Lieu Cost-effectiveness of Respiratory Syncytial Virus Prophylaxis Among Preterm Infants Pediatrics, September 1, 1999; 104(3): 419 - 427. [Abstract] [Full Text] [PDF]

				F. W. Moler RSV Immune Globulin Prophylaxis: Is an Ounce of Prevention Worth a Pound of Cure? Pediatrics, September 1, 1999; 104(3): 559 - 560. [Full Text] [PDF]

				F. W. MOLER and S. E. OHMIT Severity Of Illness Models For Respiratory Syncytial Virus-Associated Hospitalization Am. J. Respir. Crit. Care Med., April 1, 1999; 159(4): 1234 - 1240. [Abstract] [Full Text] [PDF]

				S. C. Eppes;, S. L. Lee, J. L. Robinson;, E. M. Connor, D. Carlin, F. H. Top Jr, and L. E. Weisman Questions About Palivizumab (Synagis) Pediatrics, February 1, 1999; 103(2): 534 - 535. [Full Text]