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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
Pharmacology
- Indication
Poractant alfa is indicated for the treatment of Respiratory Distress Syndrome (RDS) in premature infants.
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Treatment of Respiratory distress syndrome •••••••••••• •••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- 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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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.
Drug Interaction Integrate drug-drug
interactions in your softwareAcebutolol Acebutolol may increase the bradycardic activities of Poractant alfa. Alfentanil Alfentanil may increase the bradycardic activities of Poractant alfa. Amiodarone Amiodarone may increase the bradycardic activities of Poractant alfa. Amlodipine Amlodipine may increase the bradycardic activities of Poractant alfa. Atenolol Atenolol may increase the bradycardic activities of Poractant alfa. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Curosurf Suspension 80 mg/1mL Endotracheal Chiesi USA, Inc. 1999-11-18 Not applicable US 
Curosurf Suspension 80 mg/1mL Endotracheal Dey 2006-04-07 2006-04-07 US Curosurf Suspension 80 mg / mL Endotracheal Chiesi Farmaceutici S.P.A. 2016-12-19 Not applicable Canada 
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
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- External Links
- KEGG Drug
- D08402
- PubChem Substance
- 347910412
- 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
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Completed Treatment Hyaline Membrane Disease (HMD) / Respiratory Distress Syndrome 1 somestatus stop reason just information to hide Not Available Completed Treatment Poor Peripheral Perfusion 1 somestatus stop reason just information to hide Not Available Completed Treatment Pulmonary Haemorrhage 1 somestatus stop reason just information to hide Not Available Completed Treatment Respiratory Distress Syndrome 1 somestatus stop reason just information to hide Not Available Completed Treatment Respiratory Distress Syndrome, Newborn 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Suspension Endotracheal 80 mg / mL Suspension Endotracheal 80 mg/1mL Suspension Endotracheal 240 mg Suspension Intrapulmonary 120 mg/1.5ml Suspension Endotracheal 120 mg/1.5ml Suspension Intrapulmonary 240 mg/3ml Suspension Endotracheal 240 mg/3ml Suspension Endotracheal 1.5 ml Suspension Endotracheal 3 ml Suspension 400 mg/5ml - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
Property Value Source water solubility Insoluble. #MSDS
Drug created at September 22, 2015 16:04 / Updated at December 05, 2023 12:31