• Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

• Patient less than 24 months of age with severe immunodeficiencies (e.g. severe combined immunodeficiency or severe acquired immunodeficiency syndrome) at the start of RSV season

OR

• Patient less than 24 months of age who undergo cardiac transplantation during the RSV season

OR

First year course of prophylaxis:

• Infants born before 29 weeks, 0 days gestation younger than 12 months at the start of RSV season

OR

• Infants born before 32 weeks, 0 days gestation who are:
  • Younger than 12 months at the start of RSV season
  • Develop Chronic Lung Disease (CLD, formerly called bronchopulmonary dysplasia) of prematurity, defined as a requirement of >21% oxygen for at least the first 28 days after birth

OR

• Patient less than 12 months of age at the start of RSV season who has either congenital abnormalities of the airway or neuromuscular disease that compromises handling of respiratory secretions

OR

• Patient less than or equal to 12 months of age at the start of RSV season with hemodynamically significant congenital heart disease with ONE of the following:
  • Infant with acyanotic heart disease who is receiving medication for congestive heart failure and will require cardiac surgical procedures
  • Infant with moderate to severe pulmonary hypertension
  • Infant with cyanotic heart disease (i.e. tetralogy of Fallot) in consultation with a pediatric cardiologist

OR

• Patient less than 12 months of age at the start of RSV season with cystic fibrosis with clinical evidence of CLD and/or nutritional compromise

Second Course of Prophylaxis:

• Infants born before 32 weeks, 0 days gestation who are:
  • Younger than 24 months at the start of RSV season
  • Develop Chronic Lung Disease (CLD, formerly called bronchopulmonary dysplasia) of prematurity, defined as a requirement of >21% oxygen for at least the first 28 days after birth
  • Require medical support during the 6 month period before the start of the second RSV season (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen)

OR

• Patients less than 24 months of age with cystic fibrosis and one of the following:
  • Previous hospitalization for pulmonary exacerbation in the first year of life
  • Abnormalities on chest radiography or chest CT that persist when stable
  • Weight for length less than the 10th percentile
    

• Children older than 2 years of age.
• Infants with congenital heart disease (CHD) that is:
• Hemodynamically insignificant (e.g., secundum artrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus)
• With lesions adequately corrected by surgery, unless they continue to require medication for congestive heart failure
• Characterized as mild cardiomyopathy who are not receiving medical therapy for the condition
• More than 5 injections, except for patients that will be undergoing cardiac surgery.
• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and usage guidelines section unless there is sufficient documentation of efficacy and safety in the published literature

• Prophylaxis is administered only during the RSV season. In the temperate climates of North America, peak RSV activity typically occurs between November and April.
• If an infant or child qualifies for prophylaxis, Synagis should be continued throughout the RSV season and not be stopped because the infant or childs chronological age reaches a cut off of 24 months.
• If any infant or young child receiving monthly Synagis prophylaxis experiences a breakthrough RSV hospitalization, monthly prophylaxis should be discontinued because of the extremely low likelihood of a second RSV hospitalization in the same season (<0.5%).
• Although epidemiologic data suggest that RSV infection is more likely to lead to hospitalization for infants with risk factors including exposure to environmental air pollutants, passive household exposure to tobacco smoke has not been associated with an increased risk of RSV hospitalization on a consistent basis. Furthermore, exposure to tobacco smoke is a risk factor that can be controlled by the family of an infant at increased risk of severe RSV disease.
• Clinical evidence of CLD may include tachypnea, tachycardia, rales, intercostal recession, grunting, and nasal flaring.
• Examples of cyanotic heart diseases include tetralogy of fallot, total anomalous pulmonary venous connection, hypoplastic left heart syndrome, transposition of the great arteries, truncus arteriosus, tricuspid atresia, interrupted aortic arch, pulmonary valve atresia, pulmonary stenosis with an atrial or ventricular septal defect, and patent ductus arteriosus (in late stage).
• Some examples of hemodynamically significant heart disease are: pulmonary valve atresia, tetralogy of Fallot, single ventricle including hypoplastic left or right heart, tricuspid atresia, double outlet right ventricle with or without transposed great arteries, Ebsteins anomaly, D-transposition of great arteries with ventral septal defect (VSD), and atrial ventricular canal defect.
• Hemodynamically significant congenital heart disease alone does not qualify a patient for coverage, additional cardiac risk factors listed above are necessary.
• Synagis 50 mg and 100 mg vials are produced with a volume overfill greater than the labeled amount, approximately 0.1 ml each. Consider rounding down rather than opening a new vial (up to 10% of the dose).
• The AAP (American Academy of Pediatrics) encourages providers to prevent wastage by arranging for administration so that 2 or more eligible patients can receive the antibody within the 6-hour period after opening a vial.
• Criteria was reviewed for expanded usage for high risk infants up to 35 weeks of gestational age in November,2016. Criteria was not revised due to insufficient evidence supporting expanded usage at the time of review.

1. Synagis [Prescribing information]. Gaithersburg, MD; MedImmune, March 2014.
2. Subcommittee on Diagnosis and Management of Bronchiolitis. Diagnosis and management of bronchiolitis clinical practice guideline. Pediatrics. 2006;118(4):1174-1793.
3. Sondheimer HM, Cabalka AK, Feltes TF, Piazza FM, Connor EM, and the Cardiac Synagis Study Group. The safety and efficacy of palivizumab in children with congenital heart disease: results of a randomized, double-blind, placebo-controlled study. (abstract) Presented at the Cardiology Section of the American Academy of Pediatrics Conference, Oct 18, 2002.
4. American Academy of Pediatrics Committee on Infectious Diseases. Policy statementModified recommendations for the use of palivizumab for prevention of respiratory syncytial virus infections. Pediatrics. 2009;1694-1701.
5. American Academy of Pediatrics Committee on Infectious Diseases. Policy statement  Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for Respiratory Syncytial Virus infection. Pediatrics. 2014; 134(2): 415-420.
6. American Academy of Pediatrics Committee on Infectious Diseases. Technical report  Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for Respiratory Syncytial Virus infection. Pediatrics. 2014; 134(2): e620-e638.