VA Class:RE900

AHFS Class:

• Pulmonary Surfactants 48:36

Generic Name(s):

• Beractant

• Dipalmitoylphosphatidylcholine

Beractant is an exogenous pulmonary surfactant preparation.1,2

Respiratory Distress Syndrome

Beractant is used for the prevention or rescue treatment of hyaline membrane disease (respiratory distress syndrome [RDS]) in premature neonates.1,2 The drug is designated an orphan drug by the US Food and Drug Administration (FDA) for use in neonatal RDS.10 Beractant can reduce the incidence of RDS, mortality secondary to RDS, and air leak complications (e.g., pneumothorax, pneumopericardium).1,2 Marked improvements in oxygenation (as determined by arterial-alveolar oxygen ratio and fraction of inspired oxygen) may be evident within minutes of beractant administration.1,2 Analysis of data at 12 months follow-up indicate that infants treated with multiple doses of beractant had a lower incidence of wheezing compared with untreated infants.1,11 At 24 months follow-up, beractant-treated infants had a lower incidence of rhonchi, wheezing, and tachypnea than untreated infants.1 The manufacturer states that efficacy of beractant has not been established in controlled trials for neonates with birthweights less than 600 g or greater than 1750 g or in conjunction with investigational therapies for RDS (e.g., high-frequency ventilation, extracorporeal membrane oxygenation).1

Administration

Beractant is intended for intratracheal administration only using specialized techniques.1,2 The manufacturer's labeling and/or specialized references should be consulted for guidelines on administration techniques.1,2

Beractant should be administered by or under the supervision of clinicians experienced in intubation, ventilatory management, and general care of premature neonates since the drug can rapidly affect oxygenation and pulmonary compliance.1 Arterial or transcutaneous measurement of systemic oxygen and carbon dioxide should be performed frequently in neonates receiving the drug.1 Careful clinical observation and other measures to avoid hyperoxia are essential.1

Dosage

Dosage of beractant is expressed in terms of phospholipids.1,2 Each dose of beractant consists of 100 mg of phospholipids per kg of birthweight.1,2

The recommended intratracheal (administered via a catheter inserted into an endotracheal tube) dosage of beractant for prevention of RDS in premature neonates with low birthweight or in those with evidence of an endogenous surfactant deficiency is 100 mg of phospholipids (4 mL of Survanta^®) per kg of birthweight as soon as possible (preferably within 15 minutes) after birth and intubation.1 The recommended intratracheal dosage of the drug for active ( rescue ) treatment of RDS in neonates having radiographic evidence of the disease and requiring mechanical ventilation also is 100 mg of phospholipids per kg of birthweight;1 the first dose should be administered as soon as possible following initiation of mechanical ventilation, preferably within 8 hours of birth.1 Transient episodes of bradycardia and decreased oxygen saturation may occur during dosing; if they occur, the dosing procedure should be interrupted, and appropriate measures to alleviate the condition initiated.1 Once stabilization occurs, dosing can be resumed.1

Following an initial dose of beractant, the need for additional doses of the drug is determined by evidence of continuing respiratory distress.1 If there is evidence of continuing distress, the manufacturer states that doses of 100 mg of phospholipids per kg of birthweight (the neonate should not be reweighed) can be repeated no more frequently than every 6 hours;1 however, the manufacturer states that no more than 4 doses of beractant should be administered during the first 48 hours of life.1 The manufacturer states that the safety and efficacy of doses other than 100 mg/kg, regimens exceeding 4 doses or involving administration more frequently than every 6 hours, or administration beyond 48 hours of age have not been determined.1

The manufacturer's labeling should be consulted for more detailed dosing information.1

Description

Beractant is an exogenous surfactant preparation.1,2 Beractant, a modified natural surfactant, is a bovine lung extract containing mostly phospholipids, which has been modified by the addition of colfosceril palmitate (dipalmitoylphosphatidylcholine, DPPC, disaturated phosphatidylcholine, dipalmitoyllecithin), palmitic acid, and tripalmitin.1,2 The resultant commercially available beractant provides 25 mg/mL of phospholipids (including 11-15.5 mg/mL of disaturated phosphatidylcholine [approximately 90% of which is colfosceril palmitate]), 1.4-3.5 mg/mL of free fatty acids, 0.5-1.75 mg/mL of triglycerides, and less than 1 mg/mL of protein.1,2,3 The protein consists principally of 2 lipophilic (hydrophobic) surfactant-specific proteins (SP-B, SP-C); the hydrophilic protein, SP-35 (surfactant protein 35, apoprotein A, SAP-35, SP-A), does not appear to be present in beractant.3,4,5,6,7,8,9

Additional Information

SumMon^® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the labeling be consulted for detailed information on the usual cautions, precautions, and contraindications.

1. Ross Laboratories. Survanta^® (beractant) intratracheal suspension prescribing information. Columbus, OH: 2004 May.

2. Ross Laboratories. Neonatal respiratory distress syndrome. Columbus, OH: 1991 Mar.

3. Ross Laboratories, Columbus, OH: Personal communication.

4. Whitsett JA, Ohning BL, Ross G et al. Hydrophobic surfactant-associated protein in whole lung surfactant and its importance for biophysical activity in lung surfactant extracts used for replacement therapy. Pediatr Res . 1986; 20:460-7. [PubMed 3754957]

5. Reynolds MS, Wallander KA. Use of surfactant in the prevention and treatment of neonatal respiratory distress syndrome. Clin Pharm . 1989; 8:559-76. [PubMed 2670398]

6. Jobe A, Ikegami M. Surfactant for the treatment of respiratory distress syndrome. Am Rev Respir Dis . 1987; 136:1256-76. [PubMed 3314618]

7. Weaver TE, Whitsett JA. Structure and function of pulmonary surfactant proteins. Semin Perinatol . 1988; 12:213-20. [PubMed 3041604]

8. Chida S, Phelps DS, Cordle C et al. Surfactant-associated proteins in tracheal aspirates of infants with respiratory distress syndrome after surfactant therapy. Am Rev Respir Dis . 1988; 137:943-7. [PubMed 3355003]

9. Taeusch HW, Keough KMW, Williams M et al. Characterization of bovine surfactant for infants with respiratory distress syndrome. Pediatrics . 1986; 77:572-81. [PubMed 3634296]

10. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 28, 1996. Rockville, MD; 1996 Jul.

11. Anon. Two-year follow-up of infants treated for neonatal respiratory distress syndrome with bovine surfactant. Survanta Multidose Study Group. J Pediatr . 1994; 124:962-7. [PubMed 8201487]