Drug Information

Bovine lipid extract surfactant

Bovine lipid extract surfactant

Brand Names: Canada

  • BLES
Pharmacologic Category

  • Lung Surfactant
Dosing: PediatricRespiratory distress: Rescue treatment: Intratracheal: Infants: Administer 5 mL/kg/dose (equals phospholipids 135 mg/kg/dose); may repeat if needed, to a maximum of 4 doses within the first 5 days of life.

Dosage Forms: CanadaExcipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, intratracheal [bovine derived, preservative free]:

BLES®: Phospholipids 27 mg/mL (3 mL, 4 mL, 5 mL)

Product AvailabilityNot available in U.S.

AdministrationFor intratracheal administration only. Suction infant prior to administration. Inspect solution to verify complete mixing of the suspension (may swirl gently, but DO NOT SHAKE). Do not filter dose. After proper placement of ETT has been established, administer intratracheally by instillation through a #5-French feeding tube inserted into the infant's ETT.

Administer as a single bolus dose or administer dose in up to 3 aliquots as tolerated. Each dose or aliquot is instilled over 2-3 seconds followed by at least 30 seconds of manual ventilation. Avoid administering as a slow drip or in small aliquots as this may lead to poor distribution and uneven lung compliance.

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Infant should be supine for the first aliquot, than turned to the left and right for subsequent aliquots. Allow 1-2 minute recovery periods after each aliquot; oxygen saturation should be ~95% before administration of next aliquot. Following administration of one full dose, withhold suctioning for 2 hours unless clinically necessary.

UseTreatment of neonatal respiratory distress syndrome (NRDS)

Adverse Reactions Significant>10%:

Cardiovascular: Bradycardia (13%)

Respiratory: Pulmonary function decreased (defined as decreased oxygen saturation or increased CO2) (39%)

Miscellaneous: Sepsis (28%)

1% to 10%:

Cardiovascular: Hypotension (2%)

Central nervous system: Periventricular leukomalacia (8%), seizures (2%), hydrocephalus (1%)

Respiratory: Pulmonary interstitial emphysema (9%), pneumothorax (8%), pulmonary hemorrhage (8%), endotracheal tube complications (6%), respiratory acidosis (4%), apnea (2%), pneumonia (1%)

<1% (Limited to important or life-threatening): Acidosis, hypertension, hypoxia

ContraindicationsActive pulmonary hemorrhage

Warnings/Precautions Concerns related to adverse effects:

• Mucous plugs: Marked impairment of ventilation during or shortly after dosing may indicate mucous plugs within the endotracheal tube (ETT); suctioning prior to administration may decrease chance of ETT obstruction. Replace ETT immediately if obstruction is not removed with suctioning.

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• Sepsis: Therapy may be associated with increased incidence of sepsis; monitor closely for signs/symptoms of sepsis.

• Transient adverse effects: Transient episodes of bradycardia and decreased oxygen saturation may occur. Discontinue dosing procedure and initiate measures to alleviate the condition; may reinstitute after the patient is stable.

Other warnings/precautions:

• Administration: For intratracheal administration only. Correct any acidosis, hypoglycemia, hypothermia, or hypotension prior to administration.

• Monitoring: Rapidly affects oxygenation and lung compliance; hyperoxia may occur within minutes of administration. Assess and adjust ventilator and oxygen delivery as necessary.

• Trained personnel: Restrict use to a highly-supervised clinical setting with immediate availability of clinicians experienced in intubation and ventilatory management of premature infants.

There are no known significant interactions.

Mechanism of ActionReplaces deficient or ineffective endogenous lung surfactant in neonates with respiratory distress syndrome (RDS). Surfactant prevents the alveoli from collapsing during expiration by lowering surface tension between air and alveolar surfaces.

Pharmacodynamics/KineticsOnset of action: 5-30 minutes

REFERENCES

  1. Canadian Paediatric Society, “Recommendations for Neonatal Surfactant Therapy,” Paediatr Child Health, 2005, 10(2):109-16. [PubMed 19668609]
  2. Lam BC, Ng YK, and Wong KY, “Randomized Trial Comparing Two Natural Surfactants (Survanta vs. bLES) for Treatment of Neonatal Respiratory Distress Syndrome,” Pediatr Pulmonol, 2005, 39(1):64-9. [PubMed 15558604]
  3. Sinha S, Moya F, and Donn SM, “Surfactant for Respiratory Distress Syndrome: Are There Important Clinical Differences Among Preparations,” Curr Opin Pediatr, 2007, 19(2):150-4. [PubMed 17496757]
  4. Sweet D, Bevilacqua G, Carnielli V, et al, “European Consensus Guidelines on the Management of Neonatal Respiratory Distress Syndrome,” J Perinat Med, 2007, 35(3):175-86. [PubMed 17480144]

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