Identification
NameCalfactant
Accession NumberDB06415
TypeSmall Molecule
GroupsApproved
Description

Calfactant is a sterile, non-pyrogenic lung surfactant intended for intratracheal instillation. It is an off-white suspension of an extract of natural surfactant from calf lungs suspended in 0.9% saline. Each milliliter of calfactant contains 35mg of phospholipids (including 26 mg phosphatidylcholine of which 16 mg is disaturated phosphatidylcholine) and 0.65mg of proteins including surfactant-associated proteins B and C.

Calfactant is approved for use in the United States of America. It is used to prevent or treat respiratory distress syndrome in premature infants with lung surfactant deficiency. Calfactant has been shown to decrease the incidence of respiratory distress syndrome, mortality due to respiratory distress syndrome, and air leaks associated with respiratory distress syndrome in clinical trials. It adsorbs to the air:fluid interface in the lungs and works to reduce surface tension, in a manner similar to endogenous pulmonary surfactant.

Structure
Thumb
Synonyms
Bovactant
Calf lung surfactant extract (CLSE)
External IDs Not Available
Product Ingredients Not Available
Approved Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
InfasurfSuspension35.7 mg/mLEndotrachealOny2011-07-21Not applicableUs
Approved Generic Prescription ProductsNot Available
Approved Over the Counter ProductsNot Available
Unapproved/Other Products Not Available
International BrandsNot Available
Brand mixturesNot Available
Categories
UNIIQ4K217VGA9
CAS number183325-78-2
WeightNot Available
Chemical FormulaNot Available
InChI KeyNot Available
InChINot Available
IUPAC NameNot Available
SMILESNot Available
Pharmacology
Indication

Calfactant is indicated for prophylaxis therapy to prevent respiratory distress syndrome (RDS) in premature infants <29 weeks of gestational age with low lung surfactant and at high risk for RDS. Calfactant therapy is also indicated for the treatment of respiratory distress syndrome in infants 72 hours or less of age with RDS confirmed by clinical and radiologic findings and requiring endotracheal intubation.

Structured Indications
PharmacodynamicsNot Available
Mechanism of action

Pulmonary surfactant is an endogenous substance produced in the lungs that functions to decrease surface tension at the air:fluid interface on the alveolar surface. In premature infants with pulmonary surfactant deficiency, surface tension can increase to the point where sections of lung collapse and respiratory distress syndrome (RDS) develops. Calfactant adsorbs rapidly to the surface of the alveolar air:fluid interface and modifies surface tension to a minimum of less than 3 mN/m. It acts in a manner similar to natural lung surfactant, thus preventing or treating respiratory distress syndrome.

Related Articles
Absorption

Calfactant is administered directly to the lung lumen surface where it acts. No human studies on absorption have been completed.

Volume of distribution

No human studies on the distribution of calfactant have been performed.

Protein bindingNot Available
Metabolism

Endogenous lung surfactant is produced and excreted by Type II alveolar pneumocytes to form a surface monolayer across the alveoli through adsorption. Through repeated contraction and expansion of an alveolus, this monolayer degrades and the surfactant is taken back up into the Type II alveolar pneumocyte for re-packaging. No human studies on the metabolism of calfactant have been completed, but it is likely metabolized through a similar mechanism to endogenous pulmonary surfactant.

Route of elimination

No human studies on elimination of calfactant have been completed.

Half life

Half time clearance from the lung lumen was reported as 12 hours in a study of normal rabbits.

Clearance

No human studies on the metabolism and elimination of calfactant have been performed.

Toxicity

Carcinogenesis and animal reproduction studies have not been performed with calfactant. A single mutagenicity study produced a negative Ames assay. Overdose with calfactant has not yet been reported, but it is recommended that in the case of an overdose ventilation should be supported until all excess fluid is cleared from the lungs. Cyanosis, bradycardia and airway obstruction have been reported with administration of calfactant.

Affected organisms
  • Humans and other mammals
PathwaysNot Available
Pharmacogenomic Effects/ADRs Not Available
Interactions
Drug Interactions
DrugInteractionDrug group
AcebutololAcebutolol may increase the bradycardic activities of Calfactant.Approved
AmiodaroneAmiodarone may increase the bradycardic activities of Calfactant.Approved, Investigational
AtenololAtenolol may increase the bradycardic activities of Calfactant.Approved
BendroflumethiazideBendroflumethiazide may increase the bradycardic activities of Calfactant.Approved
BeractantCalfactant may increase the bradycardic activities of Beractant.Approved
BetaxololBetaxolol may increase the bradycardic activities of Calfactant.Approved
BisoprololBisoprolol may increase the bradycardic activities of Calfactant.Approved
BretyliumBretylium may increase the bradycardic activities of Calfactant.Approved
CarteololCarteolol may increase the bradycardic activities of Calfactant.Approved
CarvedilolCarvedilol may increase the bradycardic activities of Calfactant.Approved, Investigational
CeritinibCalfactant may increase the bradycardic activities of Ceritinib.Approved
ClonidineClonidine may increase the bradycardic activities of Calfactant.Approved
CrizotinibCalfactant may increase the bradycardic activities of Crizotinib.Approved
DexmedetomidineDexmedetomidine may increase the bradycardic activities of Calfactant.Approved, Vet Approved
DigoxinDigoxin may increase the bradycardic activities of Calfactant.Approved
DiltiazemDiltiazem may increase the bradycardic activities of Calfactant.Approved
DonepezilDonepezil may increase the bradycardic activities of Calfactant.Approved
DronedaroneDronedarone may increase the bradycardic activities of Calfactant.Approved
EsmololEsmolol may increase the bradycardic activities of Calfactant.Approved
FingolimodCalfactant may increase the bradycardic activities of Fingolimod.Approved, Investigational
GalantamineGalantamine may increase the bradycardic activities of Calfactant.Approved
GuanfacineGuanfacine may increase the bradycardic activities of Calfactant.Approved, Investigational
IvabradineCalfactant may increase the bradycardic activities of Ivabradine.Approved
LabetalolLabetalol may increase the bradycardic activities of Calfactant.Approved
LacosamideCalfactant may increase the atrioventricular blocking (AV block) activities of Lacosamide.Approved
LanreotideCalfactant may increase the bradycardic activities of Lanreotide.Approved
LevobunololLevobunolol may increase the bradycardic activities of Calfactant.Approved
LucinactantLucinactant may increase the bradycardic activities of Calfactant.Approved
MethyldopaMethyldopa may increase the bradycardic activities of Calfactant.Approved
MetipranololMetipranolol may increase the bradycardic activities of Calfactant.Approved
MetoprololMetoprolol may increase the bradycardic activities of Calfactant.Approved, Investigational
NadololNadolol may increase the bradycardic activities of Calfactant.Approved
NebivololNebivolol may increase the bradycardic activities of Calfactant.Approved, Investigational
OctreotideOctreotide may increase the bradycardic activities of Calfactant.Approved, Investigational
PasireotideCalfactant may increase the bradycardic activities of Pasireotide.Approved
PenbutololPenbutolol may increase the bradycardic activities of Calfactant.Approved, Investigational
PindololPindolol may increase the bradycardic activities of Calfactant.Approved
Poractant alfaCalfactant may increase the bradycardic activities of Poractant alfa.Approved
PropafenonePropafenone may increase the bradycardic activities of Calfactant.Approved
PropranololPropranolol may increase the bradycardic activities of Calfactant.Approved, Investigational
RivastigmineRivastigmine may increase the bradycardic activities of Calfactant.Approved, Investigational
RuxolitinibRuxolitinib may increase the bradycardic activities of Calfactant.Approved
SotalolSotalol may increase the bradycardic activities of Calfactant.Approved
SufentanilSufentanil may increase the bradycardic activities of Calfactant.Approved, Investigational
TimololTimolol may increase the bradycardic activities of Calfactant.Approved
TizanidineTizanidine may increase the bradycardic activities of Calfactant.Approved
TofacitinibTofacitinib may increase the bradycardic activities of Calfactant.Approved, Investigational
VerapamilVerapamil may increase the bradycardic activities of Calfactant.Approved
Food InteractionsNot Available
References
Synthesis Reference

Notter RH, Wang Z, Egan EA, Holm BA: Component-specific surface and physiological activity in bovine-derived lung surfactants. Chem Phys Lipids. 2002 Jan;114(1):21-34. Pubmed.

General References
  1. Willson D: Calfactant. Expert Opin Pharmacother. 2001 Sep;2(9):1479-93. [PubMed:11585026 ]
  2. Bloom BT, Clark RH: Comparison of Infasurf (calfactant) and Survanta (beractant) in the prevention and treatment of respiratory distress syndrome. Pediatrics. 2005 Aug;116(2):392-9. [PubMed:16061594 ]
  3. Willson DF, Thomas NJ, Markovitz BP, Bauman LA, DiCarlo JV, Pon S, Jacobs BR, Jefferson LS, Conaway MR, Egan EA: Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial. JAMA. 2005 Jan 26;293(4):470-6. [PubMed:15671432 ]
  4. Attar MA, Becker MA, Dechert RE, Donn SM: Immediate changes in lung compliance following natural surfactant administration in premature infants with respiratory distress syndrome: a controlled trial. J Perinatol. 2004 Oct;24(10):626-30. [PubMed:15201857 ]
  5. Nguyen TN, Cunsolo SM, Gal P, Ransom JL: Infasurf and curosurf: theoretical and practical considerations with new surfactants. J Pediatr Pharmacol Ther. 2003 Apr;8(2):97-114. doi: 10.5863/1551-6776-8.2.97. [PubMed:23300398 ]
  6. Willson DF, Zaritsky A, Bauman LA, Dockery K, James RL, Conrad D, Craft H, Novotny WE, Egan EA, Dalton H: Instillation of calf lung surfactant extract (calfactant) is beneficial in pediatric acute hypoxemic respiratory failure. Members of the Mid-Atlantic Pediatric Critical Care Network. Crit Care Med. 1999 Jan;27(1):188-95. [PubMed:9934915 ]
  7. Logan JW, Moya FR: Animal-derived surfactants for the treatment and prevention of neonatal respiratory distress syndrome: summary of clinical trials. Ther Clin Risk Manag. 2009 Feb;5(1):251-60. Epub 2009 Mar 26. [PubMed:19436610 ]
  8. Willson DF, Truwit JD, Conaway MR, Traul CS, Egan EE: The Adult Calfactant in Acute Respiratory Distress Syndrome Trial. Chest. 2015 Aug;148(2):356-64. doi: 10.1378/chest.14-1139. [PubMed:25855884 ]
  9. McPherson C, Gal P, Ransom JL, Carlos RQ, Dimaguila MA, Smith M, Davonzo C, Wimmer JE Jr: Indomethacin pharmacodynamics are altered by surfactant: a possible challenge to current indomethacin dosing guidelines created before surfactant availability. Pediatr Cardiol. 2010 May;31(4):505-10. doi: 10.1007/s00246-009-9628-6. Epub 2010 Jan 10. [PubMed:20063159 ]
External Links
ATC CodesNot Available
AHFS CodesNot Available
PDB EntriesNot Available
FDA labelDownload (35.6 KB)
MSDSNot Available
Clinical Trials
Clinical Trials
PhaseStatusPurposeConditionsCount
1, 2RecruitingPreventionBronchopulmonary Dysplasia (BPD)1
2Unknown StatusPreventionChronic Lung Disease of Prematurity1
2, 3CompletedTreatmentAcute Lung Injury (ALI)1
2, 3Unknown StatusPreventionPrimary Graft Dysfunction / Transplantation, Lung1
3CompletedTreatmentChronic Lung Disease of Prematurity / Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) / Surfactant Dysfunction1
3RecruitingTreatmentRespiratory Distress Syndrome (RDS)1
3TerminatedTreatmentRespiratory Distress Syndrome, Adult1
Not AvailableCompletedBasic ScienceCystic Fibrosis (CF)1
Not AvailableCompletedTreatmentChronic Lung Disease of Prematurity / Respiratory Distress Syndrome (RDS)1
Not AvailableCompletedTreatmentRespiratory Distress Syndrome (RDS)2
Pharmacoeconomics
ManufacturersNot Available
PackagersNot Available
Dosage forms
FormRouteStrength
SuspensionEndotracheal35.7 mg/mL
PricesNot Available
PatentsNot Available
Properties
StateLiquid
Experimental PropertiesNot Available
Predicted PropertiesNot Available
Predicted ADMET featuresNot Available
Spectra
Mass Spec (NIST)Not Available
Spectra
Spectrum TypeDescriptionSplash Key
Taxonomy
ClassificationNot classified
Drug created on March 19, 2008 10:32 / Updated on June 22, 2017 14:46