Infasurf is intended for intratracheal use only.

THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING INFASURF, OFTEN RAPIDLY IMPROVES OXYGENATION AND LUNG COMPLIANCE. Following administration of Infasurf, patients should be carefully monitored so that oxygen therapy and ventilatory support can be modified in response to changes in respiratory status.

Infasurf therapy is not a substitute for neonatal intensive care. Optimal care of premature infants at risk for RDS and newborn infants with RDS who need endotracheal intubation requires an acute care unit organized, staffed, equipped, and experienced with intubation, ventilator management, and general care of these patients.

TRANSIENT EPISODES OF REFLUX OF INFASURF INTO THE ENDOTRACHEAL TUBE, CYANOSIS, BRADYCARDIA, OR AIRWAY OBSTRUCTION HAVE OCCURRED DURING THE DOSING PROCEDURES. These events require stopping Infasurf administration and taking appropriate measures to alleviate the condition. After the patient is stable, dosing can proceed with appropriate monitoring.

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.

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