Infasurf Dosage

2.1 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.

2.2 Preparation Instructions

• INFASURF does not require reconstitution. Do not dilute or sonicate.
• INFASURF does not need to reach room temperature before administration.
• Gently swirl or agitate the INFASURF intratracheal suspension vial for redispersion. Do not shake.
• Visually inspect the INFASURF intratracheal suspension for discoloration prior to administration. The color of the INFASURF intratracheal suspension should be off-white. Discard the INFASURF vial if the intratracheal suspension is discolored. Visible flecks in the intratracheal suspension and foaming at the surface are normal.
• Using a 20-gauge or larger needle and syringe to avoid excessive foaming, withdraw INFASURF from the vial.
• Discard unopened INFASURF vials stored at room temperature for more than 24 hours.
• Discard unused INFASURF after the initial vial entry.

2.3 Administration Instructions

INFASURF should be administered by healthcare providers who are experienced in the acute care of neonates with RDS who require intubation. Two attendants should be present to facilitate dosing; one to instill the INFASURF, the other to monitor the neonate.

Administer INFASURF intratracheally through an endotracheal tube using the prepared syringe [ see Dosage and Administration (2.2)] using either of the following two methods. Instill the INFASURF dose through a:

• Side-port adapter into the endotracheal tube as two equal aliquots of 1.5 mL/kg each. During and after each aliquot that is instilled, position the neonate with either the right or the left side dependent and maintain ventilation over 20 to 30 breaths for each aliquot, with small bursts timed only during the inspiratory cycles. Between aliquot administration evaluate the respiratory status and reposition to the other side.

• 5-French feeding catheter inserted into the endotracheal tube as four equal aliquots of 0.75 mL/kg each. During and after each aliquot is instilled, position the neonate in four different positions (i.e., prone, supine, right, and left lateral) to facilitate even distribution of INFASURF. Remove the catheter between each of the instillations and resume mechanical ventilation for 0.5 to 2 minutes.

After INFASURF administration, frequently monitor neonate oxygenation and ventilatory status [ see Warnings and Precautions (5.1)].