Potential RSV Prophylaxis Candidates

This chart lists the patient groups to consider for immunoprophylaxis with Synagis, based on identified risk factors and the age of the patient at the start of the respiratory syncytial virus (RSV) season.

Candidates to consider for RSV Immunoprophylaxis

^†BPD = Bronchopulmonary dysplasia.

Documented RSV Risk Factors

School-age siblings¹
Daycare attendance^2-4 (≥ 4 hrs/wk with > 2 unrelated children)
Exposure to environmental air pollutants⁵
Severe neuromuscular disease^6,7
Congenital abnormalities of the airways^6-7
Low birth weight ⁸(<2500 g)
Crowded living conditions^1,9
Multiple birth¹⁰
Family history of asthma^1,9,11
Young chronologic age ≤ 12 weeks^1,5

References

Figueras-Aloy J, et al. Case-control study of the risk factors linked to respiratory syncytial virus infection requiring hospitalization in premature infants born at gestational age of 33-35 weeks in Spain. Pediatric Dis J. 2004;23:815-820.
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(3 Pt 1):495-500.
Holberg CJ, Wright AI, Martinez FD, et al. Child day care, smoking by caregivers, and lower respiratory tract illness in the first 3 years of life. Group Health Medical Associates. Pediatrics. 1993;91:885-892.
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.
Carbonell-Estrany X, Quero J, and the IRIS Study Group. Hospitalization rates for respiratory syncytial virus in premature infants born during two consecutive seasons. Pediatr Infect Dis J. 2001;20:874-879.
Panitch HB. Viral respiratory infections in children with technology dependence and neuromuscular disorders. Pediatr Infect Dis J. 2004;23(11):S222-S227
Arnold SR, et al. Variable morbidity of respiratory syncytial virus infection in patients with underlying disease: a review of the PICNIC RSV database. Pediatr Infect Dis J. 1999;18(10):866-869.
Lanari M, Giovannini M, Giuffre L, et al. 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.
Anderson LJ, Parker RA, Strikas RA, et al. Day-care center attendance and hospitalization for lower respiratory tract illness. Pediatrics. 1988;82:300-308.
Simoes EAF, King SJ, Lehr MV, Groothuis JR. Preterm twins and triplets: a high-risk group for severe respiratory syncytial virus infection. Am J Dis Child. 1993;147:303-306.
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.

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.