Infasurf Adverse Reactions


ONY Biotech


Full Prescribing Info
Adverse Reactions
The most common adverse reactions associated with Infasurf dosing procedures in the controlled trials were cyanosis (65%), airway obstruction (39%), bradycardia (34%), reflux of surfactant into the endotracheal tube (21%), requirement for manual ventilation (16%), and reintubation (3%). These events were generally transient and not associated with serious complications or death.
The incidence of common complications of prematurity and RDS in the 4 controlled Infasurf trials are presented in Table 3.
Prophylaxis and treatment study results for each surfactant are combined. (See Table 3.)

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Follow-Up Evaluations: Two-year follow-up data of neurodevelopmental outcomes in 415 infants enrolled in 5 centers that participated in the Infasurf versus Exosurf Neonatal controlled trials demonstrated significant developmental delays in equal percentages of Infasurf and Exosurf Neonatal patients.
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