For Healthcare Providers

Candidates for RSV Prophylaxis

Patient groups to consider for immunoprophylaxis with Synagis®, based on risk factors of the patient identified by the start of the respiratory syncytial virus (RSV) season.

High-Risk Infants Evidence-based risk factors for sever RSV disease to be considered when evaluating premature infants

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.

Synagis should not be used in pediatric patients with a history of severe prior reaction to Synagis or its components. Cases of anaphylaxis were reported following re-exposure to Synagis and severe acute hypersensitivity reactions have also been reported on initial exposure or re-exposure. If a severe hypersensitivity reaction occurs, therapy with Synagis should be permanently discontinued. If milder hypersensitivity reactions occur, caution should be used on re-administration of Synagis. In post-marketing reports, cases 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.

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References

  1. Synagis [package insert]. Gaithersburg,MD:MedImmune.
  2. McConnochie KM, Roghmann KJ. Parental smoking, presence of older siblings, and family history of asthma increase risk of bronchiolitis. Am J Dis Child. 1986;140:806-812.
  3. Figueras-Aloy J, Carbonell-Estrany X, Quero J; for the IRIS Study Group. Case-control study of the risk factors linked to respiratory syncytial virus infection requiring hospitalization in premature infants born at a gestational age of 33-35 weeks in Spain. Pediatr Infect Dis J. 2004;23:815-820.
  4. Carbonell-Estrany X, Quero J; and the IRIS Study Group. Hospitalization rates for respiratory syncytial virus infection in premature infants born during two consecutive seasons. Pediatr Infect Dis J. 2001;20:874-879.
  5. Law BJ, Langley JM, Allen U, et al. The Pediatric Investigators Collaborative Network on Infections in Canada study of predictors of hospitalization for respiratory syncytial virus infection for infants born at 33 through 35 completed weeks of gestation. Pediatr Infect Dis J. 2004;23:806-814.
  6. Holberg CJ,Wright AL,Martinez FD,MorganWJ, Taussig LM; and Group Health Medical Associates. Child day care, smoking by caregivers, and lower respiratory tract illness in the first 3 years of life. Pediatrics. 1993;91:885-892.
  7. Marbury MC,Maldonado G,Waller L. Lower respiratory illness, recurrent wheezing, and day care attendance. Am J Respir Crit Care Med. 1997;155:156-161.
  8. Celedon JC, Litonjua AA,Weiss ST, Gold DR. Day care attendance in the first year of life and illnesses of the upper and lower respiratory tract in children with a familial history of atopy. Pediatrics. 1999;104:495-500.
  9. Rossi GA, Medici MC, Arcangeletti MC, et al; and Osservatorio RSV Study Group. Risk factors for severe RSV-induced lower respiratory tract infection over four consecutive epidemics. Eur J Pediatr. 2007;166:1267-1272.
  10. Holberg CJ, Wright AL, Martinez FD, Ray CG, Taussig LM, Lebowitz MD; and Group Health Medical Associates. Risk factors for respiratory syncytial virus-associated lower respiratory illnesses in the first year of life. Am J Epidemiol. 1991;133:1135-1151.
  11. Anderson LJ, Parker RA, Strikas RA, et al. Day-care center attendance and hospitalization for lower respiratory tract illness. Pediatrics.1988;82:300-308.
  12. von Linstow ML, Hogh M, Nordbo SA, Eugen-Olsen J, Koch A, Hogh B. A community study of clinical traits and risk factors for human metapneumovirus and respiratory syncytial virus infection during the first year of life. Eur J Pediatr. 2008;167:1125-1133.
  13. Figueras-Aloy J, Carbonell-Estrany X, Quero-Jimenez J, et al; for the IRIS Study Group. FLIP-2 Study: Risk factors linked to respiratory syncytial virus infection requiring hospitalization in premature infants born in Spain at a gestational age of 32 to 35 weeks. Pediatr Infect Dis J. 2008;27:788-793.
  14. Stensballe LG, Kristensen K, Simoes EAF, et al; for the Danish RSV Data Network. Atopic disposition, wheezing, and subsequent respiratory syncytial virus hospitalization in Danish children younger than 18 months: a nested case-control study. Pediatrics. 2006;118:1360-1368.
  15. Lanari M, Giovannini M, Giuffre L, et al; and the Investigators R.A.D.A.R. Study Group. Prevalence of respiratory syncytial virus infection in Italian infants hospitalized for acute lower respiratory tract infections, and association between respiratory syncytial virus infection risk factors and disease severity. Pediatr Pulmonol. 2002;33:458-465.
  16. Cilla G, Sarasua A, Montes M, et al. Risk factors for hospitalization due to respiratory syncytial virus infection among infants in the Basque Country, Spain. Epidemiol Infect. 2006;134:506-513.
  17. Resch B, Pasnocht A, Gusenleitner W, Müller W. Rehospitalisations for respiratory disease and respiratory syncytial virus infection in preterm infants of 29-36 weeks gestational age. J Infect. 2005;50:397-403.
  18. Carroll KN, Gebretsadik T, Griffin MR, et al. Maternal asthma and maternal smoking are associated with increased risk of bronchiolitis during infancy. Pediatrics. 2007;119:1104-1112.
  19. Panitch HB. Viral respiratory infection in children with technology dependence and neuromuscular disorders. Pediatr Infect Dis J. 2004;23:S222-S227.
  20. Arnold SR, Wang EE, Law BJ, et al. Variable morbidity of respiratory syncytial virus infection in patients with underlying lung disease: a review of the PICNIC RSV database. Pediatr Infect Dis J. 1999;18:866-869.
  21. Wilkesmann A, Ammann RA, Schildgen O, et al; and the DSM RSV Ped Study Group. Hospitalized children with respiratory syncytial virus infection and neuromuscular impairment face an increased risk of a complicated course. Pediatr Infect Dis J. 2007;26:485-491.
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