Class: Pulmonary Surfactants
- Pulmonary Surfactants
VA Class: RE900
CAS Number: 108778-82-1
Exogenous natural pulmonary surfactant preparation; bovine lung extract containing mostly phospholipids.
Uses for Beractant
Respiratory Distress Syndrome (RDS)
Prevention of RDS (hyaline membrane disease) in premature neonates with birth weight <1250 g or in those with evidence of surfactant deficiency (designated an orphan drug by FDA for this use).
Treatment (rescue) of RDS in premature neonates whose disease is confirmed by radiograph and who require mechanical ventilation (designated an orphan drug by FDA for this use).
Beractant therapy associated with lower incidence of rhonchi, wheezing, and tachypnea at 24 months follow-up.
Beractant Dosage and Administration
Observe clinical status and monitor systemic oxygenation frequently to avoid hyperoxia. (See Oxygenation and Lung Compliance under Cautions.)
Following completion of dosing procedure, resume usual ventilator management and clinical care. Do not suction airways for 1 hour after dosing unless substantial obstruction occurs. (See Experience of Supervising Clinician under Cautions.)
Administer only by intratracheal instillation using specialized techniques. Consult manufacturer’s labeling and/or specialized references for guidelines on administration techniques.
Warm drug at room temperature for ≥20 minutes or warm in the hand for ≥8 minutes before administration. Avoid artificial warming methods.
Gently swirl vial to obtain a uniform suspension; do not shake. Do not filter.
Do not administer doses more frequently than every 6 hours.
Contains no preservatives; discard unused portion.
Dosage expressed in terms of phospholipids.
Each mL of the commercially available formulation contains 25 mg of phospholipids (including 11–15.5 mg disaturated phosphatidylcholine) and <1 mg of surfactant proteins (SP-B, SP-C).
Prevention of RDSIntratracheal
Premature neonates: 100 mg/kg (4 mL/kg) of birth weight, given in 4 divided doses. Give first quarter-dose as soon as possible (preferably within 15 minutes after birth).
Administer repeat doses (100 mg/kg of birth weight) if neonate has radiographically confirmed RDS, remains intubated, and requires ≥30% inspired oxygen to maintain a PaO2 ≤80 torr.
Treatment (Rescue) of RDSIntratracheal
Premature neonates: 100 mg/kg (4 mL/kg) of birth weight, given in 4 divided doses. Give first quarter-dose as soon as possible (preferably within 8 hours after birth).
Administer repeat doses (100 mg/kg of birth weight) if neonate remains intubated and requires ≥30% inspired oxygen to maintain a PaO2 ≤80 torr.
Premature neonates: Maximum 4 doses within first 48 hours of life. Safety and efficacy not established for single doses >100 mg/kg of birth weight or for administration beyond 48 hours of life.
Cautions for Beractant
No known contraindications.
Experience of Supervising Clinician
Use by or under supervision of clinicians experienced in intubation, ventilatory management, and general care of premature neonates.
Oxygenation and Lung Compliance
Therapy can rapidly affect oxygenation and lung compliance. Perform arterial or transcutaneous measurement of systemic oxygen and carbon dioxide frequently to avoid hyperoxia.
Transient episodes of decreased oxygen saturation reported. If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy.
Transient episodes of bradycardia reported. If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy.
Possible post-treatment nosocomial sepsis. Sepsis not associated with increased mortality.
Rales and moist breath sounds may occur transiently. Endotracheal suctioning or other corrective measures not necessary unless obvious signs of airway obstruction are present.
Use with Investigational Treatments for RDS
Safety and efficacy in conjunction with investigational therapies for RDS (e.g., high-frequency ventilation, extracorporeal membrane oxygenation) not established.
Not intended for use in adults.
Not intended for use in adults.
Safety and efficacy not established in neonates with birth weights <600 g or >1750 g.
Common Adverse Effects
Transient bradycardia, oxygen desaturation, endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, apnea.
Interactions for Beractant
No drug interactions reported.
No pharmacokinetic studies in humans.
Marked improvements in oxygenation occur within minutes of administration.
Improvements in arterial-alveolar oxygen ratio (a/APO2), FiO2, and mean airway pressure (MAP) sustained for 48–72 hours following administration.
2–8° C in carton. Protect from light. Usual color of commercially available suspension is off-white to light brown.
Prior to use, warm at room temperature for up to 24 hours (see Intratracheal Administration under Dosage and Administration); record date and time whenever vial is removed from refrigerator.
May return unopened, unused vials to refrigerator within 24 hours of warming. Do not warm and return to refrigeration more than once.
Natural bovine lung extract containing mostly phospholipids and small amounts of neutral lipids, fatty acids, and surfactant-associated proteins (SP-B, SP-C).
Endogenous pulmonary surfactant reduces alveolar surface tension and increases alveolar stability.
Beractant compensates for surfactant deficiency in premature neonates. Restores pulmonary compliance and improves lung pressure-volume measurements and oxygenation in animals.
Advice to Patients
Advise patient’s parent(s) or guardian of risk of bradycardia and decreased oxygen saturation.
Importance of informing parent(s) or guardian of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
25 mg (of phospholipids) per mL
AHFS DI Essentials™. © Copyright 2022, Selected Revisions May 1, 2006. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.