Survanta

Generic Name: Beractant
Class: Pulmonary Surfactants
VA Class: RE900
CAS Number: 108778-82-1

Introduction

Exogenous natural pulmonary surfactant preparation; bovine lung extract containing mostly phospholipids.1 2

Uses for Survanta

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).1 2

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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).1 2 10

Beractant therapy associated with lower incidence of rhonchi, wheezing, and tachypnea at 24 months follow-up.1 11

Survanta Dosage and Administration

General

  • Observe clinical status and monitor systemic oxygenation frequently to avoid hyperoxia.1 (See Oxygenation and Lung Compliance under Cautions.)

  • Following completion of dosing procedure, resume usual ventilator management and clinical care.1 Do not suction airways for 1 hour after dosing unless substantial obstruction occurs.1 (See Experience of Supervising Clinician under Cautions.)

Administration

Intratracheal Administration

Administer only by intratracheal instillation using specialized techniques.1 2 Consult manufacturer’s labeling and/or specialized references for guidelines on administration techniques.1 2

Warm drug at room temperature for ≥20 minutes or warm in the hand for ≥8 minutes before administration.1 Avoid artificial warming methods.1

Gently swirl vial to obtain a uniform suspension; do not shake.1 Do not filter.1

Do not administer doses more frequently than every 6 hours.1

Contains no preservatives; discard unused portion.1

Dosage

Dosage expressed in terms of phospholipids.1

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).1

Pediatric Patients

RDS
Prevention of RDS
Intratracheal

Premature neonates: 100 mg/kg (4 mL/kg) of birth weight, given in 4 divided doses.1 Give first quarter-dose as soon as possible (preferably within 15 minutes after birth).1

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.1

Treatment (Rescue) of RDS
Intratracheal

Premature neonates: 100 mg/kg (4 mL/kg) of birth weight, given in 4 divided doses.1 Give first quarter-dose as soon as possible (preferably within 8 hours after birth).1

Administer repeat doses (100 mg/kg of birth weight) if neonate remains intubated and requires ≥30% inspired oxygen to maintain a PaO2 ≤80 torr.1

Prescribing Limits

Pediatric Patients

RDS
Intratracheal

Premature neonates: Maximum 4 doses within first 48 hours of life.1 Safety and efficacy not established for single doses >100 mg/kg of birth weight or for administration beyond 48 hours of life.1

Cautions for Survanta

Contraindications

  • No known contraindications.1

Warnings/Precautions

Warnings

Experience of Supervising Clinician

Use by or under supervision of clinicians experienced in intubation, ventilatory management, and general care of premature neonates.1

Oxygenation and Lung Compliance

Therapy can rapidly affect oxygenation and lung compliance.1 Perform arterial or transcutaneous measurement of systemic oxygen and carbon dioxide frequently to avoid hyperoxia.1

Transient episodes of decreased oxygen saturation reported.1 If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy.1

Cardiovascular Effects

Transient episodes of bradycardia reported.1 If this occurs, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy.1

Major Toxicities

Infectious Complications

Possible post-treatment nosocomial sepsis.1 Sepsis not associated with increased mortality.1

General Precautions

Respiratory Effects

Rales and moist breath sounds may occur transiently.1 Endotracheal suctioning or other corrective measures not necessary unless obvious signs of airway obstruction are present.1

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.1

Specific Populations

Pregnancy

Not intended for use in adults.1

Lactation

Not intended for use in adults.1

Pediatric Use

Safety and efficacy not established in neonates with birth weights <600 g or >1750 g.1

Common Adverse Effects

Transient bradycardia, oxygen desaturation, endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, apnea.1

Interactions for Survanta

No drug interactions reported.1

Survanta Pharmacokinetics

No pharmacokinetic studies in humans.1

Absorption

Onset

Marked improvements in oxygenation occur within minutes of administration.1 2

Duration

Improvements in arterial-alveolar oxygen ratio (a/APO2), FiO2, and mean airway pressure (MAP) sustained for 48–72 hours following administration.1

Stability

Storage

Intratracheal

Suspension

2–8° C in carton.1 Protect from light.1 Usual color of commercially available suspension is off-white to light brown.1

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.1

May return unopened, unused vials to refrigerator within 24 hours of warming.1 Do not warm and return to refrigeration more than once.1

Actions

  • Natural bovine lung extract containing mostly phospholipids and small amounts of neutral lipids, fatty acids, and surfactant-associated proteins (SP-B, SP-C).1

  • Endogenous pulmonary surfactant reduces alveolar surface tension and increases alveolar stability.1

  • Beractant compensates for surfactant deficiency in premature neonates.1 Restores pulmonary compliance and improves lung pressure-volume measurements and oxygenation in animals.1

Advice to Patients

  • Advise patient’s parent(s) or guardian of risk of bradycardia and decreased oxygen saturation.1

  • Importance of informing parent(s) or guardian of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Beractant (Bovine)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Intratracheal

Suspension, sterile

25 mg (of phospholipids) per mL

Survanta

Ross

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions May 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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. [IDIS 257816] [PubMed 2670398]

6. Jobe A, Ikegami M. Surfactant for the treatment of respiratory distress syndrome. Am Rev Respir Dis. 1987; 136:1256-76. [IDIS 236107] [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. [IDIS 240444] [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 folow-up of infants treated for neonatal respiratory distress syndrome with bovine surfactant. Survanta Multidose Study Group. J Pediatr. 1994; 124:962-7.

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