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Poractant Alfa

Class: Pulmonary Surfactants
VA Class: RE900
CAS Number: 129069-19-8
Brands: Curosurf

Introduction

Exogenous natural pulmonary surfactant preparation; porcine lung extract containing mostly phospholipids.1 3

Uses for Poractant Alfa

Respiratory Distress Syndrome (RDS)

Treatment (rescue) of RDS (hyaline membrane disease) in premature neonates (designated an orphan drug by FDA for this use).1 2 6 8

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Prevention of RDS in infants at high risk for RDS.3 7 8

Poractant Alfa Dosage and Administration

General

  • Observe clinical status and monitor systemic oxygenation frequently; decrease inspired oxygen concentrations and ventilator pressures gradually to prevent hyperoxia.1 2

  • 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 Consult manufacturer’s labeling or specialized references for guidelines on administration techniques.1 2

Allow drug to reach room temperature before administration.1 Gently invert vial to obtain a uniform suspension; do not shake.1

Contains no preservatives; discard unused portion.1

Dosage

Available as poractant alfa; dosage expressed in terms of phospholipids.1 4 5

Each mL of the commercially available formulation contains 80 mg of phospholipids (including 54 mg of phosphatidylcholine, of which 30.5 mg is dipalmitoyl phosphatidylcholine) and 1 mg of surfactant proteins (SP-B, SP-C).1 2 8

Pediatric Patients

Treatment of RDS
Intratracheal

Premature neonates: 2.5 mL/kg (200 mg/kg) of birthweight.1

Administer up to 2 repeat doses (1.25 mL/kg of birth weight), given at 12-hour intervals, if neonate remains intubated and respiratory manifestations of RDS persist or worsen.1

Prevention of RDS
Intratracheal

100 or 200 mg/kg, given as a single dose within 10 minutes of birth.3 7

Prescribing Limits

Pediatric Patients

Treatment of RDS
Intratracheal

Premature neonates: Total dosage (initial and repeat doses) should not exceed 5 mL/kg.1 Safety and efficacy not established for administration of >3 doses (1 initial and 2 repeat doses), administration more frequently than every 12 hours, and initiation of therapy >15 hours after diagnosis of RDS.1

Cautions for Poractant Alfa

Contraindications

  • No known contraindications.1

Warnings/Precautions

Warnings

Experience of Supervising Clinician

Use only by clinicians experienced in resuscitation, stabilization, and general care of premature neonates.1

Respiratory Effects

Therapy can rapidly affect oxygenation and lung compliance.1 Perform frequent clinical and laboratory assessments; modify oxygen and ventilatory support in response to respiratory changes.1 2

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 and monitor appropriately.1

Cardiovascular Effects

Transient episodes of bradycardia and hypotension reported.1 If these occur, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.1

Endotracheal Tube Complications

Transient endotracheal tube blockage, reflux of surfactant into endotracheal tube, and airway obstruction reported.1 If these occur, discontinue administration and initiate appropriate measures to alleviate the condition; following stabilization, resume therapy and monitor appropriately.1

General Precautions

Concurrent Illness

Correction of acidosis, hypotension, anemia, hypoglycemia, and hypothermia recommended prior to administration.1

Complications of Prematurity

Therapy expected to reduce severity of RDS but will not eliminate morbidity and mortality associated with other complications of prematurity (e.g., pneumonia, septicemia, intracranial hemorrhage, patent ductus arteriosus).1

Use with Investigational Treatments for RDS

Safety and efficacy in conjunction with investigational therapies for RDS (e.g., high-frequency ventilation) not established.1

Specific Populations

Pregnancy

Not intended for use in adults.1

Lactation

Not intended for use in adults.1

Common Adverse Effects

Transient bradycardia, hypotension, endotracheal tube blockage, decreased oxygen saturation.1

Interactions for Poractant Alfa

No drug interactions reported.1

Poractant Alfa Pharmacokinetics

No pharmacokinetic studies in humans.1

Absorption

Onset

Marked improvements in oxygenation occur within minutes of administration.1

Stability

Storage

Intratracheal

Suspension

2–8° C.1 Protect from light.1

Prior to use, warm to room temperature for up to 24 hours.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 porcine lung extract containing mostly phospholipids and small amounts of neutral lipids, fatty acids, and surfactant-associated proteins (SP-B, SP-C).1 3

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

  • Poractant compensates for surfactant deficiency in premature neonates.1 Increases alveolar stability and pulmonary compliance, decreases pulmonary edema and work required for breathing, and facilitates uniform alveolar recruitment on inspiration.1 3

Advice to Patients

  • Advise patient’s parent(s) or guardian that other complications of prematurity (e.g., pneumonia, septicemia, intracranial hemorrhage, patent ductus arteriosus) will not be eliminated by poractant therapy.1

  • Importance of informing parent(s) or guardian of other important precautionary information. (See Cautions.)1

Preparations

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

Poractant Alfa

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Intratracheal

Suspension

1.5 mL (120 mg phospholipids)

Curosurf

Dey

3 mL (240 mg phospholipids)

Curosurf

Dey

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Dey. Curosurf (poractant alfa) intratracheal suspension prescribing information. Napa, CA; 2000 Feb.

2. Anon. Med Lett Drugs Ther. 42; 2000;27-8.

3. Wiseman LR, Bryson HM. Porcine-derived lung surfactant: a review of the therapeutic efficacy and clinical tolerability of a natural surfactant preparation (Curosurf) in neonatal respiratory distress syndrome. Drugs. 1994; 48:386-403. [PubMed 7527760]

4. Collaborative European Multicenter Study Group. Surfactant replacement therapy for severe neonatal respiratory distress syndrome: an international randomized clinical trial. Pediatrics. 1988; 82:683-91. [IDIS 247745] [PubMed 2903480]

5. Speer CP, Robertson B, Curstedt T et al. Randomized European multicenter trial of surfactant replacement therapy for severe neonatal respiratory distress syndrome: single versus multiple doses of Curosurf. Pediatrics. 1992; 89:13-20. [IDIS 290105] [PubMed 1727997]

6. 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). Rockville, MD; [December 18, 2000]. From FDA web site ().

7. Egberts J, Brand R, Walti H et al. Mortality, severe respiratory distress syndrome, and chronic lung disease of the newborn are reduced more after prophylactic than after therapeutic administration of the surfactant Curosurf. Pediatrics. 1997; 100: E4. [IDIS 427502] [PubMed 9200378]

8. Dey, Napa, CA: Personal communication.

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