Infasurf is indicated for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment ("rescue") of premature infants who develop RDS. Infasurf decreases the incidence of RDS, mortality due to RDS and air leaks associated with RDS.
Infasurf therapy is intended for infants greater than or equal to 72 hours of age with RDS and requiring endotracheal intubation.
The efficacy of Infasurf was demonstrated in two multiple-dose controlled clinical trials involving approximately 2,000 infants treated with Infasurf (approximately 100mg phospholipid/kg) or Exosurf Neonatal. In addition, two controlled trials of Infasurf versus Survanta and four uncontrolled trials were conducted that involved approximately 15,500 patients treated with Infasurf.
The most common side effects occurring with Infasurf were: cyanosis, airway obstruction, bradycardia, reflux of surfactant into the endotracheal tube, requirement for manual vantilation and reintubation. These events were generally transient and not associated with serious complications or death.