SURFAXIN LS™ (lyophilized formulation)
SURFAXIN LSTM is a lyophilized (dry powder) formulation of KL4 Surfactant intended
to improve the convenience of product use for healthcare practitioners, eliminate the need for cold-chain storage, and potentially further improve product clinical performance.
The lyophilized product is intended to be reconstituted with sterile water and administered, like SURFAXIN® liquid instillate and current surfactants, into the endotracheal
tube (ETT) of a mechanically ventilated patient. SURFAXIN LSTM has the potential, over time, to displace the animal-derived products and significantly increase the total market value
of ETT delivered surfactants above the current global market of approximately $200 million.
IMPORTANT SAFETY INFORMATION
SURFAXIN (lucinactant intratracheal suspension) is intended for intratracheal use only.
The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance. SURFAXIN should be administered only by clinicians trained and
experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent
clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status. Most common adverse reactions associated with the use of
SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for dose interruption. During SURFAXIN administration, if bradycardia, oxygen desaturation,
endotracheal tube reflux, or airway obstruction occurs, administration should be interrupted and the infant's clinical condition assessed and stabilized. SURFAXIN is not indicated for
use in acute respiratory distress syndrome (ARDS).
SURFAXIN LSTM is an investigational drug and not approved for use by the US Food & Drug Administration or any other world health authority.