NAV

Poractant alfa

Identification

Summary

Poractant alfa is a pulmonary surfactant used for the treatment of Respiratory Distress Syndrome (RDS) in premature infants.

Brand Names
Curosurf
Generic Name
Poractant alfa
DrugBank Accession Number
DB09113
Background

Poractant alfa is a pulmonary surfactant marketed as Curosurf in the United States and Canada. It is used to treat Respiratory Distress Syndrome (RDS) in premature infants with an endogenous pulmonary surfactant deficiency. Poractant alfa is an extract of natural porcine lung surfactant consisting of 99% polar lipids (mainly phospholipids) and 1% hydrophobic low molecular weight proteins (surfactant associated proteins SP-B and SP-C). The phospholipid content of the extract consists primarily of phosphatidylcholine and dipaImitoylphosphatidylcholine. Poractant alfa is a creamy white suspension of this extract in 0.9% sodium chloride solution. It contains no preservatives.

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Other protein based therapies
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
Not Available
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Pharmacology

Indication

Poractant alfa is indicated for the treatment of Respiratory Distress Syndrome (RDS) in premature infants.

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofRespiratory distress syndrome••••••••••••••••••••
Contraindications & Blackbox Warnings
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Pharmacodynamics

Poractant alfa improved lung compliance, pulmonary gas exchange and survival in preterm rabbits.

Mechanism of action

Endogenous pulmonary surfactant reduces surface tension at the air-liquid interface of the alveoli in the lungs, thus stabilizing them against collapse under transpulmonary pressures. A deficiency of pulmonary surfactant in premature infants allows surface tension to increase to the point where sections of lung collapse and respiratory distress syndrome (RDS) develops. Poractant alfa lowers minimum surface tension to less than or equal to 4 mN/m. This compensates for the lack of endogenous surfactant and restores adequate surface activity to the lungs.

Absorption

Poractant alfa is administered directly to the site of action in the lungs via endotracheal tube. It very rapidly adsorbs to the air-liquid interface to form a stable surfactant monolayer. No studies on absorption of poractant alfa have been performed in humans.

Volume of distribution

No studies on the distribution of poractant alfa have been performed in humans.

Protein binding

Not Available

Metabolism

No studies on the metabolism of poractant alfa have been performed in humans. One small study in rabbits did find that poractant alfa may be degraded by macrophages and that it may, in part, be recycled in the alveoli in a similar manner to endogenous lung surfactant.

Route of elimination

No studies on elimination of poractant alfa have been performed in humans.

Half-life

The half-life of poractant alfa has only been evaluated in animal studies. When studied in adult and newborn rabbits, the half-life in the lungs was found to be 25 and 67 respectively.

Clearance

No studies on clearance of poractant alfa have been performed in humans.

Adverse Effects
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Toxicity

Studies on the carcinogenicity or reproductive effects of poractant alfa have not been conducted. Mutagenicity assays were negative. In the case of an overdose with poractant alfa where there are clear clinical effects on the infant's respiration, ventilation, or oxygenation, it is recommended that as much of the solution be aspirated as possible and the infant be managed with supportive measures. Fluid and electrolyte balances should be monitored closely in this case.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
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interactions in your software
AcebutololAcebutolol may increase the bradycardic activities of Poractant alfa.
AlfentanilAlfentanil may increase the bradycardic activities of Poractant alfa.
AmiodaroneAmiodarone may increase the bradycardic activities of Poractant alfa.
AmlodipineAmlodipine may increase the bradycardic activities of Poractant alfa.
AtenololAtenolol may increase the bradycardic activities of Poractant alfa.
Food Interactions
No interactions found.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
CurosurfSuspension80 mg/1mLEndotrachealChiesi USA, Inc.1999-11-18Not applicableUS flag
CurosurfSuspension80 mg/1mLEndotrachealDey2006-04-072006-04-07US flag
CurosurfSuspension80 mg / mLEndotrachealChiesi Farmaceutici S.P.A.2016-12-19Not applicableCanada flag

Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
  • Humans and other mammals

Chemical Identifiers

UNII
KE3U2023NP
CAS number
129069-19-8

References

Synthesis Reference

Curosurf: Product Monograph. Parma, Italy: Chiesi Farmaceutici S.p.A.; 2008: 25-27.

General References
  1. Fujii AM, Carillo M: Animal-derived surfactant treatment of respiratory distress syndrome in premature neonates: a review. Drugs Today (Barc). 2009 Sep;45(9):697-709. doi: 1396674/dot.2009.45.9.1418185. [Article]
  2. Jeon GW, Oh M, Sin JB: Efficacy of surfactant-TA, calfactant and poractant alfa for preterm infants with respiratory distress syndrome: a retrospective study. Yonsei Med J. 2015 Mar;56(2):433-9. doi: 10.3349/ymj.2015.56.2.433. [Article]
  3. Alberti A, Pettenazzo A, Enzi GB, Palamidese A, Mapp C, Ventura P, Baritussio A: Uptake and degradation of Curosurf after tracheal administration to newborn and adult rabbits. Eur Respir J. 1998 Aug;12(2):294-300. [Article]
  4. Bourbon JR, Chailley-Heu B, Gautier B: The exogenous surfactant Curosurf enhances phosphatidylcholine content in isolated type II cells. Eur Respir J. 1997 Apr;10(4):914-9. [Article]
  5. Calkovska A, Uhliarova B, Joskova M, Franova S, Kolomaznik M, Calkovsky V, Smolarova S: Pulmonary surfactant in the airway physiology: a direct relaxing effect on the smooth muscle. Respir Physiol Neurobiol. 2015 Apr;209:95-105. doi: 10.1016/j.resp.2015.01.004. Epub 2015 Jan 10. [Article]
  6. Cogo PE, Facco M, Simonato M, Verlato G, Rondina C, Baritussio A, Toffolo GM, Carnielli VP: Dosing of porcine surfactant: effect on kinetics and gas exchange in respiratory distress syndrome. Pediatrics. 2009 Nov;124(5):e950-7. doi: 10.1542/peds.2009-0126. Epub 2009 Oct 12. [Article]
  7. Singh N, Halliday HL, Stevens TP, Suresh G, Soll R, Rojas-Reyes MX: Comparison of animal-derived surfactants for the prevention and treatment of respiratory distress syndrome in preterm infants. Cochrane Database Syst Rev. 2015 Dec 21;12:CD010249. doi: 10.1002/14651858.CD010249.pub2. [Article]
  8. 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 Sep;48(3):386-403. [Article]
  9. Sweet D, Bevilacqua G, Carnielli V, Greisen G, Plavka R, Saugstad OD, Simeoni U, Speer CP, Valls-I-Soler A, Halliday H: European consensus guidelines on the management of neonatal respiratory distress syndrome. J Perinat Med. 2007;35(3):175-86. [Article]
  10. Schurch S, Schurch D, Curstedt T, Robertson B: Surface activity of lipid extract surfactant in relation to film area compression and collapse. J Appl Physiol (1985). 1994 Aug;77(2):974-86. [Article]
  11. Malloy CA, Nicoski P, Muraskas JK: A randomized trial comparing beractant and poractant treatment in neonatal respiratory distress syndrome. Acta Paediatr. 2005 Jun;94(6):779-84. [Article]
  12. Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K: A randomized, multicenter masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. Am J Perinatol. 2004 Apr;21(3):109-19. [Article]
  13. Speer CP, Robertson B, Curstedt T, Halliday HL, Compagnone D, Gefeller O, Harms K, Herting E, McClure G, Reid M, et al.: Randomized European multicenter trial of surfactant replacement therapy for severe neonatal respiratory distress syndrome: single versus multiple doses of Curosurf. Pediatrics. 1992 Jan;89(1):13-20. [Article]
KEGG Drug
D08402
PubChem Substance
347910412
RxNav
236381
ChEMBL
CHEMBL1201622
RxList
RxList Drug Page
Drugs.com
Drugs.com Drug Page
Wikipedia
Poractant_alfa
FDA label
Download (529 KB)
MSDS
Download (60.4 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedPreventionRespiratory Distress Syndrome, Newborn1
4CompletedTreatmentChronic Lung Disease of Prematurity / Infant, Premature, Diseases / Respiratory Distress Syndrome, Newborn1
4CompletedTreatmentMeconium Aspiration Syndrome1
4CompletedTreatmentRespiratory Distress Syndrome, Newborn / Respiratory Failure1
4Not Yet RecruitingTreatmentRespiratory Distress Syndrome1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SuspensionEndotracheal80 mg/1mL
SuspensionEndotracheal80 mg / mL
SuspensionEndotracheal240 mg
SuspensionIntrapulmonary120 mg/1.5ml
SuspensionEndotracheal120 mg/1.5ml
SuspensionIntrapulmonary240 mg/3ml
SuspensionEndotracheal240 mg/3ml
SuspensionEndotracheal
Suspension400 mg/5ml
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
PropertyValueSource
water solubilityInsoluble. #MSDS

Drug created at September 22, 2015 16:04 / Updated at December 05, 2023 12:31