Pharmacological Class:
Pulmonary surfactant.
Active Ingredient(s):
Lucinactant 8.5mL/vial; contains phospholipids 30mg (dipalmitoylphosphatidylcholine 22.5mg, palmitoyloleoyl-phosphatidylglycerol 7.5mg, sodium salt), palmitic acid 4.05mg, sinapultide 0.862mg; per mL; susp for intratracheal administration; preservative-free.
Company
Discovery Laboratories, Inc.
Indication(s):
For the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS.
Pharmacology:
Endogenous pulmonary surfactant lowers surface tension at the air-liquid interface of the alveolar surfaces during respiration and stabilizes the alveoli against collapse at resting transpulmonary pressures. A deficiency of pulmonary surfactant in premature infants results in RDS. Surfaxin compensates for the deficiency of surfactant and restores surface activity to the lungs of these infants.
Clinical Trials:
The efficacy and safety of Surfaxin for the prevention of RDS in premature infants was demonstrated in a single randomized, double-blind, multicenter, active-controlled, multi-dose study involving 1,294 premature infants (Study 1). Within the first 30 minutes after birth, infants were randomized to receive 1 of 3 surfactants, Surfaxin (N = 527), colfosceril palmitate (N = 509), or beractant (N = 258). Surfaxin was administered at a dose of 5.8mL/kg, colfosceril palmitate at a dose of 5mL/kg, and beractant at a dose of 4mL/kg. Infants in the Surfaxin and beractant groups could be given up to 3 additional doses between 6 and 24 hours of birth, as often as every 6 hours, if they subsequently developed RDS and required mechanical ventilation with an FiO2 ≥ 0.3 and a mean airway pressure (MAP) ≥ 6cm H2O. Infants in the colfosceril palmitate group could receive up to 2 additional doses at least 12 hours apart if they met the retreatment criteria. Some infants received sham air to maintain blinding of the study.
Co-primary endpoints were the incidence of RDS (defined as having a chest x-ray consistent with RDS and an FiO2 ≥ 0.3) at 24 hours and RDS-related mortality at 14 days. The primary comparison of interest was between Surfaxin and colfosceril palmitate with the intent of demonstrating superiority. Beractant served as an additional active comparator. Compared to colfosceril palmitate, Surfaxin demonstrated a statistically significant improvement in both RDS at 24 hours (39% of patients on Surfaxin vs. 47% of patients on colfosceril palmitate) and RDS-related mortality through Day 14 (5% of patients for Surfaxin vs. 9% of patients for colfosceril palmitate).
A second multicenter, double-blind, active-controlled study involving 252 premature infants was also conducted (Study 2), however the study was terminated prematurely and can only be used to support the safety of Surfaxin relevant to another surfactant product.
Legal Classification:
Rx
Adults:
Not recommended.
Children:
See full labeling. For intratracheal administration only. 5.8mL/kg. Can give up to 4 doses in the first 48hrs of life, not more frequently than every 6hrs.
Warnings/Precautions:
Not for treating acute RDS. Should be administered only by clinicians trained and experienced in intubation, ventilator management, and general care of premature infants. Monitor respiratory status frequently. Interrupt dosing and assess status if bradycardia, oxygen desaturation, reflux of drug into endotracheal tube (ETT) or airway/ETT obstruction occurs.
Adverse Reaction(s)
Endotracheal tube reflux, pallor, endotracheal tube obstruction, need for dose interruption.
How Supplied:
Single-use vial—1
LAST UPDATED:
1/2/2014
