General: BLES (bovine lipid extract surfactant) is intended for intratracheal use only (See Dosage & Administration).
Use of BLES should be restricted to a highly supervised clinical setting with immediate availability of experienced neonatologists and other clinicians experienced with intubation, ventilator management, and general care of premature infants.
A higher rate of sepsis has been described in those infants treated with BLES than those in the control arm. Health professionals caring for these infants should be aware of this increased risk, take appropriate precautionary measures and be vigilant for any signs and symptoms of sepsis.
Carcinogenesis and Mutagenesis: No studies have been performed to investigate the carcinogenesis or mutagenesis of BLES.
Immunogenicity: Long-term studies comparing BLES to placebo (sham air) treatment demonstrated no significant differences in development of allergic manifestations.
Ophthalmologic: Hyperoxia may occur within minutes of administration of BLES. If hyperoxia develops and oxygen saturation is in excess of 95%, FiO2 should be reduced until saturation is 90 to 95%, to decrease the risk of retinopathy of prematurity.
Respiratory: Vigilant clinical attention should be given to all infants prior to, during and after administration of BLES. Monitor infants for oxygenation with a transcutaneous oxygen probe or oxygen saturation monitor as well as occasional blood gas measurements. In addition, carbon dioxide (CO2) levels should be monitored with transcutaneous CO2 probe correlated with blood gas readings.
BLES can rapidly affect oxygenation and lung compliance. If the improvement in chest expansion seems excessive, peak ventilator inspiratory pressures should be reduced immediately, to avoid over distension and pulmonary air leaks. Monitor tidal volume after dosing, as sudden lung compliance may occur without much chest movement.
During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported (See Adverse Reactions). If these occur, the dosing procedure should be stopped and appropriate measures to alleviate the condition initiated. After stabilization, the dosing procedure can be resumed.
Administration techniques used with other surfactant products, such as slow administration or the use of small test aliquots, are not recommended with BLES. Unlike other products that require a slow drip to prevent reflux, BLES has a much lower viscosity and a higher protein content that promote a more rapid distribution. Slow administration may lead to uneven distribution, resulting in uneven lung compliance.
If the dose fails to subside in the ETT with additional pressures, consider the possibility of a mucous plug.
Mucous Plugs: Infants whose ventilation becomes markedly impaired during or shortly after dosing may have mucous plugging of the endotracheal tube, particularly if pulmonary secretions were prominent prior to drug administration. Suctioning of all infants prior to dosing may lessen the chance of mucous plugs obstructing the endotracheal tube. After dosing, exogenous surfactant may encourage the transport of resident mucus. If endotracheal tube obstruction from such plugs is suspected, and suctioning is unsuccessful in removing the obstruction, the blocked endotracheal tube should be replaced immediately.
Monitoring and Laboratory Tests: Correction of acidosis, hypotension, hypoglycemia and hypothermia is recommended prior to administration.