Coagulation factor X human

Identification

Name
Coagulation factor X human
Accession Number
DB13148
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Blood factors
Description

Coagulation Factor X (Human), is a plasma-derived human blood coagulation factor is used by adults and children (aged 12 years and above) with hereditary Factor X deficiency. However its use is limited in the perioperative setting for the management of bleeding in major surgery in patients with moderate and severe hereditary Factor X deficiency.

Coagulation Factor X is a vitamin K-dependent, liver-produced serine protease that serves as the first enzyme in the coagulation cascade to form fibrin. It is a two-chain glycoprotein with the molecular weight of approximately 59 kDa 2. While Factor X normally circulates in the plasma as inactive molecules, the activation of Factor X is involved in both the intrinsic and extrinsic coagulation pathways. Inherited factor X deficiency is a rare autosomal recessive bleeding disorder that is estimated to occur in 1:1 000 000 individuals up to 1:500 carriers 1. Administration of coagulation Factor X from healthy donor serves to restore and achieve effective hemostasis.

Coagulation Factor X (Human) solution is approved by the FDA for intravenous injection under the market name Coagadex which contains normally 100 IU/mL of coagulation Factor X derived from healthy donors who have passed viral screening tests Label.

Protein structure
Db13148
Protein chemical formula
Not Available
Protein average weight
59000.0 Da
Sequences
Not Available
Synonyms
  • Coagulation factor X
  • Coagulation factor X (human)
  • Factor X
  • Factor X (stuart prower factor)
  • Human coagulation factor X
  • Stuart-prower factor
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
CoagadexKit100 [iU]/1mLIntravenousBio Products Laboratory Limited2015-10-21Not applicableUs
CoagadexKit100 [iU]/1mLIntravenousBio Products Laboratory Limited2015-10-21Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Beriplex P/n 1000Coagulation factor X human (2040 unit) + Coagulation Factor IX Human (1240 unit) + Coagulation factor VII human (1000 unit) + Protein C (1640 unit) + Protein S human (1360 unit) + Prothrombin (1600 unit)Powder, for solutionIntravenousCsl Behring2013-11-21Not applicableCanada
Beriplex P/n 500Coagulation factor X human (1020 unit) + Coagulation Factor IX Human (620 unit) + Coagulation factor VII human (500 unit) + Protein C (820 unit) + Protein S human (680 unit) + Prothrombin (800 unit)Powder, for solutionIntravenousCsl Behring2011-07-28Not applicableCanada
Feiba Vh Immuno Anti InhibitorCoagulation factor X human + Antihemophilic factor human (4 unit) + Coagulation factor VII human + Factor IX Complex (Human) + ProthrombinPowder, for solutionIntravenousOsterreichisches Institut Fur Haemoderivate Ges M.B.H.1986-12-311998-08-13Canada
KcentraCoagulation factor X human (1520 U/40mL) + Coagulation Factor IX Human (1020 U/40mL) + Coagulation factor VII human (700 U/40mL) + Protein C (1240 U/40mL) + Protein S human (920 U/40mL) + Prothrombin (1180 U/40mL)KitIntravenousCSL Behring GmbH2013-12-13Not applicableUs
KcentraCoagulation factor X human (760 U/20mL) + Coagulation Factor IX Human (510 U/20mL) + Coagulation factor VII human (350 U/20mL) + Protein C (620 U/20mL) + Protein S human (460 U/20mL) + Prothrombin (590 U/20mL)KitIntravenousCSL Behring GmbH2013-04-29Not applicableUs
OctaplexCoagulation factor X human (1200 unit) + Coagulation Factor IX Human (1000 unit) + Coagulation factor VII human (960 unit) + Protein C (1240 unit) + Protein S human (1280 unit) + Prothrombin (1520 unit)Kit; Powder, for solutionIntravenousOctapharma Pharmazeutika Produktionsges M B H2015-08-11Not applicableCanada
OctaplexCoagulation factor X human (600 unit) + Coagulation Factor IX Human (500 unit) + Coagulation factor VII human (480 unit) + Protein C (620 unit) + Protein S human (640 unit) + Prothrombin (760 unit)Kit; Powder, for solutionIntravenousOctapharma Pharmazeutika Produktionsges M B H2008-07-08Not applicableCanada
Categories
UNII
HYF6HN9XGQ
CAS number
Not Available

Pharmacology

Indication

Indicated in adults and children (aged 12 years and above) with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes, or for perioperative management of bleeding in patients with mild hereditary Factor X deficiency Label.

Associated Conditions
Pharmacodynamics

Clinical human coagulation Factor X solution increases plasma levels of Factor X and can temporarily correct the coagulation defect in these patients, as reflected by decrease in the activated Partial Thromboplastin Time (aPTT) and prothrombin time (PT) Label.

Mechanism of action

Factor X is an inactive zymogen that is synthesized in the liver, which can be activated by Factor IXa (via the intrinsic pathway) or by Factor VIIa (via the extrinsic pathway). It is composed of a light chain which contains the Gla (glutamic acid) domain and two epidermal growth factor domains, and a heavy chain that contains the catalytic serine protease domain 1. The conversion of inactive Factor X into the active form Factor Xa requires the cleavage of a 52-residue peptide from the heavy chain Label and the release of 52-residue activation peptide that contains the His236, Asp228 and Ser379 catalytic site. This activation step can occur through the extrinsic or intrinsic pathway and is considered to be the first step in the common pathway to fibrin formation 1.

Factor Xa plays a critical initiation step of the coagulation pathway by cleaving and activating prothrombin to thrombin in complex with FVa, Ca2+ and phospholipids. This complex is also known as the prothrombinase complex. Thrombin then acts upon soluble fibrinogen and Factor XIII to generate a cross-linked fibrin clot Label,3.

Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

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Additional Data Available
Blackbox Warnings

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Absorption

Following a single intravenous dose of 25 IU/kg, the mean peak plasma concentration (CV%) was 0.504 (17.2) IU/mL Label.

Volume of distribution

Following a single intravenous dose of 25 IU/kg, the mean volume of distribution at steady state (CV%) was 56.3 (24.0) mL/kg Label.

Protein binding
Not Available
Metabolism
Not Available
Route of elimination
Not Available
Half life

Following a single intravenous dose of 25 IU/kg, the mean plasma half-life (CV%) was 30.3 (22.8) hr Label.

Clearance

Following a single intravenous dose of 25 IU/kg, the mean total body clearance was 1.35 (21.7) mL/kg/hr Label.

Toxicity
Not Available
Affected organisms
  • Humans and other mammals
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
(R)-warfarinThe therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with (R)-warfarin.
(S)-WarfarinThe therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with (S)-Warfarin.
4-hydroxycoumarinThe therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with 4-hydroxycoumarin.
AbciximabThe therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with Abciximab.
AcenocoumarolThe therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with Acenocoumarol.
Acetylsalicylic acidThe therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with Acetylsalicylic acid.
Alpha-1-proteinase inhibitorAlpha-1-proteinase inhibitor may increase the thrombogenic activities of Coagulation factor X human.
AlteplaseThe therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with Alteplase.
AmediplaseThe therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with Amediplase.
Aminocaproic acidThe risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Coagulation factor X human.
Additional Data Available
  • Extended Description
    Extended Description

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  • Severity
    Severity

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  • Evidence Level
    Evidence Level

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  • Action
    Action

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Food Interactions
Not Available

References

General References
  1. Brown DL, Kouides PA: Diagnosis and treatment of inherited factor X deficiency. Haemophilia. 2008 Nov;14(6):1176-82. doi: 10.1111/j.1365-2516.2008.01856.x. [PubMed:19141158]
  2. Venkateswarlu D, Perera L, Darden T, Pedersen LG: Structure and dynamics of zymogen human blood coagulation factor X. Biophys J. 2002 Mar;82(3):1190-206. doi: 10.1016/S0006-3495(02)75476-3. [PubMed:11867437]
  3. Palta S, Saroa R, Palta A: Overview of the coagulation system. Indian J Anaesth. 2014 Sep;58(5):515-23. doi: 10.4103/0019-5049.144643. [PubMed:25535411]
External Links
PubChem Substance
347911432
RxNav
4262
ATC Codes
B02BD13 — Coagulation factor x
FDA label
Download (288 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedTreatmentHealthy Volunteers1
1CompletedTreatmentThrombotic events1
2Not Yet RecruitingTreatmentTrauma Injury1
2RecruitingOtherBleeding in Cardiac Surgery1
3CompletedPreventionFactor X Deficiency1
3CompletedTreatmentAcute Major Bleeding / Disorders, Blood Coagulation1
3CompletedTreatmentFactor X Deficiency1
3CompletedTreatmentReversal of Anticoagulant Treatment1
3CompletedTreatmentReversal of Coagulopathy1
3RecruitingTreatmentCongestive Heart Failure / Heart Disease End Stage1
3RecruitingTreatmentSignificant Bleeding Risk1
3TerminatedTreatmentFactor X Deficiency1
4Enrolling by InvitationTreatmentBleeding / Blood Loss,Surgical / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates1
4WithdrawnTreatmentPostpartum Haemorrhage (PPH)1
Not AvailableCompletedNot AvailableHemorrhage1
Not AvailableRecruitingNot AvailableFactor 10 Deficiency1
Not AvailableRecruitingNot AvailableHemorrhage1
Not AvailableWithdrawnTreatmentIntracranial Hemorrhage, Spontaneous / Intracranial Hemorrhage, Traumatic1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
KitIntravenous100 [iU]/1mL
Powder, for solutionIntravenous
KitIntravenous
Kit; powder, for solutionIntravenous
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Taxonomy

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

Drug created on November 18, 2016 13:47 / Updated on March 01, 2020 21:26

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