Lucinactant approved for premie RDS

June 15, 2012

FDA approves Lucinactant and Peginesatide


(Surfaxin, Discovery Laboratories)

Safety. In SELECT, the most common adverse effects of lucinactant are related to its administration down a premature infant's endotracheal tube and include endotracheal tube reflux (18 events per 100 doses), skin paleness (9 events per 100 doses), and endotracheal tube obstruction (6 events per 100 doses), often resulting in infants' needing a dose interruption (9 events per 100 doses). Administration-related adverse reactions were more common in premature infants receiving lucinactant compared to control surfactants. Oxygen desaturation was reported in 17%, 9%, and 13%, and bradycardia for 5%, 2%, and 3% of infants treated with lucinactant, colfosceril palmitate, and beractant, respectively.

Dosing. The recommended dose of lucinactant is 5.8 mL/kg birthweight administered by intratracheal administration. Up to 4 doses of lucinactant can be administered in the first 48 hours of life; however, doses should be given no more frequently than every 6 hours. Dosing should be interrupted if administration-related adverse reactions occur.