Synagis® (palivizumab)

Synagis (palivizumab) is covered only for prevention of RSV lower respiratory tract disease in specified high‑risk pediatric groups—FDA‑approved for preterm infants (born <29w GA and <12 months at RSV season start), chronic lung disease of prematurity (born <32w with >21% O2 for first 28 days and age/therapy criteria), and hemodynamically significant CHD (<12 months with cardiology/intensivist involvement)—and for compendial off‑label groups (airway anomalies/neuromuscular disorders impairing secretion clearance, profoundly immunocompromised children, and cardiac transplant patients, some eligible to <24 months); other indications are excluded. Key requirements: must meet the specific gestational‑age and age‑at‑season criteria with documentation (gestational age, oxygen/therapy history, specialist consults/prescriptions where required), dosing is 15 mg/kg IM monthly for up to 5 doses per RSV season, and off‑season single doses require regional RSV activity thresholds per CDC NREVSS (≥10% rapid antigen or ≥3% PCR within 2 weeks).