Calfactant

1 INDICATIONS AND USAGE INFASURF is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS. for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. INFASURF ® is a surfactant indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates < 29 weeks gestational age at risk for RDS. (1) for the rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. (1)

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Acute Changes in Oxygenation and Lung Compliance [ see Warnings and Precautions (5.1 )] Administration-Related Adverse Reactions [see Warnings and Precautions (5.2) ] Intraventricular Hemorrhage and Periventricular Leukomalacia [ see Warnings and Precautions (5.3) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

5 WARNINGS AND PRECAUTIONS 5.1 Acute Changes in Oxygenation and Lung Compliance The administration of exogenous surfactants, including INFASURF, can rapidly affect oxygenation and lung compliance. Frequently monitor neonates who receive INFASURF so that oxygen and ventilatory support can be modified in response to changes in respiratory status. INFASURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm neonates with RDS who require intubation. 5.2 Administration-Related Adverse Reactions Administration-related adverse reactions associated with INFASURF use included cyanosis, bradycardia, airway obstruction, and reflux of INFASURF into the endotracheal tube. 4 CONTRAINDICATIONS None. None.