Dosage and Administration for Infasurf®

FOR INTRATRACHEAL ADMINISTRATION ONLY Infasurf® should be administered under the supervision of clinicians experienced in the acute care of newborn infants with respiratory failure who require intubation.

Rapid and substantial increases in blood oxygenation and improved lung compliance often follow Infasurf® instillation. Close clinical monitoring and surveillance following administration may be needed to adjust oxygen therapy and ventilator pressures appropriately.

Dosage
Each dose of Infasurf® is 3 mL/kg body weight at birth. Infasurf® has been administered every 12 hours for a total of up to 3 doses.

Directions for Use
Infasurf® is a suspension which settles during storage. Gentle swirling or agitation of the vial is often necessary for redispersion. DO NOT SHAKE. Visible flecks in the suspension and foaming at the surface are normal for Infasurf®.

Infasurf® should be stored at refrigerated temperature 2°-8°C (36°-46°F). Warming of Infasurf® before administration is not necessary.

Unopened, unused vials of Infasurf® that have warmed to room temperature can be returned to refrigerated storage within 24 hours for future use. Repeated warming to room temperature should be avoided. Each single-use vial should be entered only once and the vial with any unused material should be discarded after the initial entry.

Infasurf® DOES NOT REQUIRE RECONSTITUTION. DO NOT DILUTE OR SONICATE.

Dosing Procedures

General
Infasurf® should only be administered intratracheally through an endotracheal tube. The dose of Infasurf® is 3 mL/kg birth weight. The dose is drawn into a syringe from the single-use vial using a 20-gauge or larger needle with care taken to avoid excessive foaming. Administration is made by instillation of the Infasurf® suspension into the endotracheal tube.

Administration for Treatment of RDS

Initial Dose
Infasurf® should be administered intratracheally through a side-port adapter into the endotracheal tube. Two attendants, one to instill the Infasurf®, the other to monitor the patient and assist in positioning, facilitate the dosing. The dose (3 mL/kg) should be administered in two aliquots of 1.5 mL/kg each. After each aliquot is instilled, the infant should be positioned with either the right or the left side dependent. Administration is made while ventilation is continued over 20-30 breaths for each aliquot, with small bursts timed only during the inspiratory cycles. A pause followed by evaluation of the respiratory status and repositioning should separate the two aliquots.

Repeat Doses
Repeat doses of 3 mL/kg of birth weight, up to a total of 3 doses 12 hours apart, have been given in the Infasurf® controlled clinical trials if the patient was still intubated.

In the Infasurf® versus Survanta® trials, Infasurf® was administered through a 5 French feeding catheter inserted into the endotracheal tube. The total dose was instilled in four equal aliquots with the catheter removed between each of the instillations and mechanical ventilation resumed for 0.5 to 2 minutes. Each of the aliquots was administered with the patient in one of four different positions (prone, supine, right, and left lateral) to facilitate even distribution of the surfactant. Repeat doses were administered as early as 6 hours after the previous dose for a total of up to four doses if the infant was still intubated and required at least 30% inspired oxygen to maintain a PaO2 £ 80 torr.

Administration for Prophylaxis of RDS at Birth
The amount of a prophylaxis dose of Infasurf® should be based on the infant's birth weight. Administration of Infasurf® should be given as soon as possible after birth. Usually the immediate care and stabilization of the premature infant born with hypoxemia and or bradycardia should precede Infasurf® prophylaxis.

The dosing procedures are described under Administration for Treatment of RDS.

Dosing Precautions
During administration of Infasurf® liquid suspension into the airway, infants often experience bradycardia, reflux of Infasurf® into the endotracheal tube, airway obstruction, cyanosis, dislodgement of the endotracheal tube, or hypoventilation. If any of these events occur, the administration should be interrupted and the infant's condition should be stabilized using appropriate interventions before the administration of Infasurf® is resumed. Endotracheal suctioning or reintubation is sometimes needed when there are signs of airway obstruction during the administration of the surfactant.

HOW SUPPLIED
Infasurf® (calfactant) Intratracheal Suspension is supplied sterile in single-use, rubber-stoppered glass vials containing 6 mL off-white suspension (NDC 0456-4600-06).

Store Infasurf® (calfactant) Intratracheal Suspension at refrigerated temperature 2° to 8°C (36° to 46°F) and protect from light. Vials are for single use only. After opening, discard unused drug.