NAV

Prothrombin

Identification

Summary

Prothrombin is a coagulation factor used for emergency reversal of vitamin K antagonist therapy.

Brand Names
Balfaxar, Beriplex, Kcentra, Octaplex
Generic Name
Prothrombin
DrugBank Accession Number
DB11311
Background

Prothrombin Complex Concentrate (Human), is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.

Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Blood factors
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
>sp|P00734|THRB_HUMAN Prothrombin OS=Homo sapiens GN=F2 PE=1 SV=2
MAHVRGLQLPGCLALAALCSLVHSQHVFLAPQQARSLLQRVRRANTFLEEVRKGNLEREC
VEETCSYEEAFEALESSTATDVFWAKYTACETARTPRDKLAACLEGNCAEGLGTNYRGHV
NITRSGIECQLWRSRYPHKPEINSTTHPGADLQENFCRNPDSSTTGPWCYTTDPTVRRQE
CSIPVCGQDQVTVAMTPRSEGSSVNLSPPLEQCVPDRGQQYQGRLAVTTHGLPCLAWASA
QAKALSKHQDFNSAVQLVENFCRNPDGDEEGVWCYVAGKPGDFGYCDLNYCEEAVEEETG
DGLDEDSDRAIEGRTATSEYQTFFNPRTFGSGEADCGLRPLFEKKSLEDKTERELLESYI
DGRIVEGSDAEIGMSPWQVMLFRKSPQELLCGASLISDRWVLTAAHCLLYPPWDKNFTEN
DLLVRIGKHSRTRYERNIEKISMLEKIYIHPRYNWRENLDRDIALMKLKKPVAFSDYIHP
VCLPDRETAASLLQAGYKGRVTGWGNLKETWTANVGKGQPSVLQVVNLPIVERPVCKDST
RIRITDNMFCAGYKPDEGKRGDACEGDSGGPFVMKSPFNNRWYQMGIVSWGEGCDRDGKY
GFYTHVFRLKKWIQKVIDQFGE
Download FASTA Format
Synonyms
  • Coagulation factor II (human)
  • Coagulation factor II human
  • Factor II
  • Factor II (prothrombin)
  • Human coagulation factor II
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Pharmacology

Indication

For use in the emergency reversal of coagulation factor deficiency in patients receiving vitamin K antagonist therapy. Prothrombin is administered as part of a cocktail containing several coagulation factors.

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Used in combination for prophylaxis ofBleedingCombination Product in combination with: Protein C (DB11312), Coagulation Factor IX (Recombinant) (DB00100), Protein S human (DB13149), Coagulation factor X human (DB13148), Coagulation factor VII human (DB13150)•••••••••••••••••••••••••••••••••••• ••••••• ••• ••••••••
Used in combination to treatVitamin k antagonist induced major bleedingRegimen in combination with: Coagulation Factor IX Human (DB13152), Protein C (DB11312), Coagulation factor VII human (DB13150), Protein S human (DB13149), Coagulation factor X human (DB13148), Prothrombin (DB11311)••••••••••••
Contraindications & Blackbox Warnings
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Pharmacodynamics

Not Available

Mechanism of action
TargetActionsOrganism
AFibrinogen alpha chain
cleavage
Humans
AFibrinogen beta chain
cleavage
Humans
ACoagulation factor XIII A chain
agonist
Humans
ACarboxypeptidase B2
agonist
Humans
Absorption

Not Available

Volume of distribution

Not Available

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Not Available

Half-life

Approximately 60h 1.

Clearance

Not Available

Adverse Effects
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Toxicity

Not Available

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
AbciximabThe therapeutic efficacy of Prothrombin can be decreased when used in combination with Abciximab.
AcenocoumarolThe therapeutic efficacy of Prothrombin can be decreased when used in combination with Acenocoumarol.
Alpha-1-proteinase inhibitorAlpha-1-proteinase inhibitor may increase the thrombogenic activities of Prothrombin.
AlteplaseThe therapeutic efficacy of Prothrombin can be decreased when used in combination with Alteplase.
Aminocaproic acidThe risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Prothrombin.
Food Interactions
No interactions found.

Products

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
BalfaxarProthrombin (26 [iU]/1mL) + Coagulation Factor IX Human (25.5 [iU]/1mL) + Coagulation factor VII human (16.5 [iU]/1mL) + Coagulation factor X human (24 [iU]/1mL) + Protein C (22 [iU]/1mL) + Protein S human (22 [iU]/1mL)Powder, for solutionIntravenousOctapharma USA Inc2023-11-30Not applicableUS flag
Beriplex P/n 1000Prothrombin (1600 unit) + Coagulation Factor IX Human (1240 unit) + Coagulation factor VII human (1000 unit) + Coagulation factor X human (2040 unit) + Protein C (1640 unit) + Protein S human (1360 unit)Powder, for solutionIntravenousCsl Behring2013-11-21Not applicableCanada flag
Beriplex P/N 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer InjektionslösungProthrombin (1360 IE) + Coagulation Factor IX Human (1020 IE) + Coagulation factor VII human (700 IE) + Coagulation factor X human (1640 IE) + Protein C (1200 I.E.) + Protein S human (1000 IE)Injection, powder, for solutionParenteralCsl Behring2013-04-16Not applicableAustria flag
Beriplex P/N 250 I.E. Pulver und Lösungsmittel zur Herstellung einer InjektionslösungProthrombin (340 I.E.) + Coagulation Factor IX Human (255 IE) + Coagulation factor VII human (175 IE) + Coagulation factor X human (410 IE) + Protein C (300 IE) + Protein S human (250 IE)Injection, powder, for solutionParenteralCsl Behring2008-02-27Not applicableAustria flag
Beriplex P/n 500Prothrombin (800 unit) + Coagulation Factor IX Human (620 unit) + Coagulation factor VII human (500 unit) + Coagulation factor X human (1020 unit) + Protein C (820 unit) + Protein S human (680 unit)Powder, for solutionIntravenousCsl Behring2011-07-28Not 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
8FB1K07F16
CAS number
9001-26-7

References

General References
  1. 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. [Article]
PubChem Substance
347911184
RxNav
1441689
Wikipedia
Thrombin
FDA label
Download (638 KB)
MSDS
Download (77.5 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4CompletedTreatmentBleeding / Blood Loss During Surgery / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates1
4CompletedTreatmentHemophilia A1
4RecruitingTreatmentCoagulation Disorder / Massive Hemorrhage / Traumatic haemorrhage1
4WithdrawnTreatmentPostpartum Haemorrhage (PPH)1
3CompletedTreatmentAcute Major Bleeding / Coagulation Disorder1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, powder, for solutionIntravenous
InjectionIntravenous
Powder, for solutionIntravenous
Injection, powder, lyophilized, for solution; kitIntravenous
Powder, for solutionParenteral
Kit; powder, for solutionIntravenous
Injection, powder, for solutionIntravenous drip520 IU/vial
Injection, powder, for solutionParenteral
SolutionIntravenous
Prices
Not Available
Patents
Not Available

Properties

State
Liquid
Experimental Properties
Not Available

Targets

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Details1. Fibrinogen alpha chain
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Cleavage
General Function
Structural molecule activity
Specific Function
Cleaved by the protease thrombin to yield monomers which, together with fibrinogen beta (FGB) and fibrinogen gamma (FGG), polymerize to form an insoluble fibrin matrix. Fibrin has a major function ...
Gene Name
FGA
Uniprot ID
P02671
Uniprot Name
Fibrinogen alpha chain
Molecular Weight
94972.455 Da
References
  1. 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. [Article]
  2. UniProt: Fibrinogen Alpha Chain [Link]
Details2. Fibrinogen beta chain
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Cleavage
General Function
Structural molecule activity
Specific Function
Cleaved by the protease thrombin to yield monomers which, together with fibrinogen alpha (FGA) and fibrinogen gamma (FGG), polymerize to form an insoluble fibrin matrix. Fibrin has a major function...
Gene Name
FGB
Uniprot ID
P02675
Uniprot Name
Fibrinogen beta chain
Molecular Weight
55927.9 Da
References
  1. 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. [Article]
  2. UniProt: Fibrinogen Beta Chain [Link]
Details3. Coagulation factor XIII A chain
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Agonist
General Function
Protein-glutamine gamma-glutamyltransferase activity
Specific Function
Factor XIII is activated by thrombin and calcium ion to a transglutaminase that catalyzes the formation of gamma-glutamyl-epsilon-lysine cross-links between fibrin chains, thus stabilizing the fibr...
Gene Name
F13A1
Uniprot ID
P00488
Uniprot Name
Coagulation factor XIII A chain
Molecular Weight
83266.805 Da
References
  1. 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. [Article]
Details4. Carboxypeptidase B2
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Agonist
General Function
Zinc ion binding
Specific Function
Cleaves C-terminal arginine or lysine residues from biologically active peptides such as kinins or anaphylatoxins in the circulation thereby regulating their activities. Down-regulates fibrinolysis...
Gene Name
CPB2
Uniprot ID
Q96IY4
Uniprot Name
Carboxypeptidase B2
Molecular Weight
48423.85 Da
References
  1. 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. [Article]

Enzymes

Details1. Coagulation factor X
Kind
Protein
Organism
Humans
Pharmacological action
No
Actions
Substrate
General Function
Serine-type endopeptidase activity
Specific Function
Factor Xa is a vitamin K-dependent glycoprotein that converts prothrombin to thrombin in the presence of factor Va, calcium and phospholipid during blood clotting.
Gene Name
F10
Uniprot ID
P00742
Uniprot Name
Coagulation factor X
Molecular Weight
54731.255 Da
References
  1. 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. [Article]

Drug created at December 03, 2015 16:52 / Updated at May 21, 2021 10:21