Calfactant

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. for the rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation.

Endogenous lung surfactant is essential for effective ventilation because it modifies alveolar surface tension thereby stabilizing the alveoli. Lung surfactant deficiency is the cause of Respiratory Distress Syndrome (RDS) in preterm neonates. INFASURF is a lung surfactant that restores lung surface activity in preterm neonates with RDS by adsorbing to the surface of the air:liquid interface and modifying surface tension similarly to natural lung surfactant.

Recommended Dosage The recommended dose of INFASURF is 3 mL/kg body weight at birth administered intratracheally through an endotracheal tube. INFASURF can be administered every 12 hours for a total of up to three doses. To reduce the risk of RDS in preterm neonates <29 weeks of gestational age at risk for RDS, administer INFASURF within 30 minutes after birth.

None. None.

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.

The following clinically significant adverse reactions are described elsewhere in the labeling: Acute Changes in Oxygenation and Lung Compliance Administration-Related Adverse Reactions Intraventricular Hemorrhage and Periventricular Leukomalacia

INFASURF (calfactant) intratracheal suspension is an off-white suspension available in a sterile, rubber-stoppered glass single-dose vial packaged as one vial per carton: 105 mg/3 mL (35 mg/mL) (NDC 61938-456-03) 210 mg/6 mL (35 mg/mL) (NDC 61938-456-06) Refrigerate INFASURF (calfactant) intratracheal suspension at 2°C to 8°C (36°F to 46°F) and protect from light. Do not remove INFASURF from the refrigerator for more than 24 hours. Unopened, unused INFASURF vials that have reached room temperature within 24 hours can be refrigerated for future use, however, do not re-refrigerate INFASURF more than once. Record the date and time on the carton when INFASURF is removed from the refrigerator.