Infasurf Special Precautions


ONY Biotech


Full Prescribing Info
Special Precautions
When repeat dosing was given at fixed 12-hr intervals in the Infasurf versus 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 eg, high-frequency ventilation.
Data from controlled trials on the efficacy of Infasurf are limited to doses of approximately phospholipid 100 mg/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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