Infasurf Special Precautions

When repeat dosing was given at fixed 12-hour intervals in the Infasurf vs. Exosurf Neonatal trials, transient episodes of cyanosis, bradycardia, reflux of surfactant into the endotracheal tube, and airway obstruction were observed more frequently among infants in the Infasurf-treated group.
An increased proportion of patients with both intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) was observed in Infasurf-treated infants in the Infasurf-Exosurf Neonatal controlled trials. These observations were not associated with increased mortality.
No data are available on the use of Infasurf in conjunction with experimental therapies of RDS, e.g., high-frequency ventilation.
Data from controlled trials on the efficacy of Infasurf are limited to doses of approximately 100 mg phospholipid/kg body weight and up to a total of 4 doses.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenesis studies and animal reproduction studies have not been performed with Infasurf. A single mutagenicity study (Ames assay) was negative.