Coagulation factor VII human

Identification

Summary

Coagulation factor VII human is a coagulation factor used to treat bleeding disorders such as hemophilia and Glanzmann's thrombasthenia.

Brand Names
Balfaxar, Beriplex, Kcentra, Octaplex
Generic Name
Coagulation factor VII human
DrugBank Accession Number
DB13150
Background

Coagulation factor VII is human serine protease type enzyme that is involved in the extrinsic coagulation cascade which results in blood clotting.

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Blood factors
Protein Chemical Formula
Not Available
Protein Average Weight
Not Available
Sequences
Not Available
Synonyms
  • Coagulation factor VII (human)
  • Factor VII
  • Factor VII (proconvertin)
  • Factor VII human
  • Human coagulation factor VII
  • Proconvertin
  • Serum prothrombin conversion accelerator

Pharmacology

Indication

May be administered in cases of uncontrolled bleeding. Factor VII alone can be used in the treatment of congenital hemophilia A or B, acquired hemophilia, congenital factor VII deficiency, and Glanzmann's thrombasthenia. Off label use in the treatment of refractory bleeding after cardiac surgery and warfarin related intracerebral hemorrhage. Brands for human factor VII are currently only in combination with other vitamin K coagulation factors and can be used to reverse vitamin K antagonist activity in patients with acute major bleeds or for urgent surgery/invasive procedures.

Along with other blood coagulation factors, it is used to reverse acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with a need for an urgent surgery/invasive procedure.5

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

Human Factor VII complexes with tissue factor resulting in its activation to VIIa. It is the activated Factor VIIa that then binds to Factor X activating it to Factor Xa, as well as coagulation Factor IX is activated to Factor IXa. Factor Xa continues the coagulation cascade to eventually convert prothrombin to thrombin, which leads to the formation of a clot by converting fibrinogen to fibrin.

Mechanism of action

Factor VII is required in the extrinsic clotting cascade. When there is vascular damage tissue factor (TF) is released which then interacts with Factor VII resulting in the formation of the activated complex VIIa. Factor VIIa then continues to activate coagulation factors in the cascade until a clot is formed.

TargetActionsOrganism
ATissue factor
activator
Humans
ACoagulation factor X
activator
Humans
ACoagulation factor IX
activator
Humans
Absorption

No absorption since given IV.

Volume of distribution

45 ml/kg

Protein binding

Binds to coagulation factor X and IX and tissue factor.

Metabolism

Degraded by catabolism

Route of elimination

Catabolism

Half-life

5 h

Clearance

7.4 ml/kgh

Adverse Effects
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Toxicity

No evidence of toxicity. Adverse effect of excessive clotting in certain individuals.

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
AbciximabThe therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Abciximab.
AcenocoumarolThe therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Acenocoumarol.
Alpha-1-proteinase inhibitorAlpha-1-proteinase inhibitor may increase the thrombogenic activities of Coagulation factor VII human.
AlteplaseThe therapeutic efficacy of Coagulation factor VII human 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 Coagulation factor VII human.
Food Interactions
No interactions found.

Products

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

Categories

ATC Codes
B02BD01 — Coagulation factor ix, ii, vii and x in combinationB02BD05 — Coagulation factor vii
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
Not Available

Chemical Identifiers

UNII
4156XVB4QD
CAS number
Not Available

References

Synthesis Reference

Björkman S, Berntorp E. Pharmacokinetics of coagulation factors: clinical relevance for patients with haemophilia. Clinical Pharmacokinetics [serial on the Internet]. (2001), [cited March 3, 2017]; 40(11): 815-832. Available from: MEDLINE.

Mackman, N. (2009). The Role of Tissue Factor and Factor VIIa in Hemostasis. Anesthesia and Analgesia, 108(5), 1447–1452. http://doi.org/10.1213/ane.0b013e31819bceb1

General References
  1. Cartmill M, Dolan G, Byrne JL, Byrne PO: Prothrombin complex concentrate for oral anticoagulant reversal in neurosurgical emergencies. Br J Neurosurg. 2000 Oct;14(5):458-61. [Article]
  2. Frontera JA, Lewin JJ 3rd, Rabinstein AA, Aisiku IP, Alexandrov AW, Cook AM, del Zoppo GJ, Kumar MA, Peerschke EI, Stiefel MF, Teitelbaum JS, Wartenberg KE, Zerfoss CL: Guideline for Reversal of Antithrombotics in Intracranial Hemorrhage: A Statement for Healthcare Professionals from the Neurocritical Care Society and Society of Critical Care Medicine. Neurocrit Care. 2016 Feb;24(1):6-46. doi: 10.1007/s12028-015-0222-x. [Article]
  3. Broze GJ Jr, Majerus PW: Purification and properties of human coagulation factor VII. J Biol Chem. 1980 Feb 25;255(4):1242-7. [Article]
  4. KCENTRA monograph [Link]
  5. FDA Approved Drug Products: BALFAXAR (prothrombin complex concentrate, human-lans) lyophilized powder for solution, for intravenous use (July 2023) [Link]
PubChem Substance
347911434
RxNav
4254

Clinical Trials

Clinical Trials
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PhaseStatusPurposeConditionsCountStart DateWhy Stopped100+ additional columns
4CompletedTreatmentBleeding / Blood Loss During Surgery / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates1somestatusstop reasonjust information to hide
4CompletedTreatmentCongenital Hematological Disorder / Hemophilia A With Inhibitors / Hemophilia B With Inhibitors3somestatusstop reasonjust information to hide
4RecruitingTreatmentCoagulation Disorder / Massive Hemorrhage / Traumatic haemorrhage1somestatusstop reasonjust information to hide
4WithdrawnTreatmentPostpartum Haemorrhage (PPH)1somestatusstop reasonjust information to hide
3CompletedTreatmentAcquired Bleeding Disorder / Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass1somestatusstop reasonjust information to hide

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Injection, powder, for solutionIntravenous
InjectionIntravenous
Injection, powder, lyophilized, for solutionIntravenous600 IU
Injection, powder, lyophilized, for solutionIntravenous60000000 IU
Injection, powder, for solutionParenteral600 I.E.
Powder, for solutionIntravenous
Injection, powder, lyophilized, for solution; kitIntravenous
Kit; powder, for solutionIntravenous
Injection, powder, for solutionIntravenous drip520 IU/vial
Injection, powder, for solutionParenteral
Injection, powder, lyophilized, for solutionIntravenous200 IU/10ml
Injection, powder, lyophilized, for solutionIntravenous500 IU/10ml
Powder, for solutionIntravenous200 UI
Powder, for solutionIntravenous600 UI
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Targets

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Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Activator
General Function
Protease binding
Specific Function
Initiates blood coagulation by forming a complex with circulating factor VII or VIIa. The [TF:VIIa] complex activates factors IX or X by specific limited protolysis. TF plays a role in normal hemos...
Gene Name
F3
Uniprot ID
P13726
Uniprot Name
Tissue factor
Molecular Weight
33067.3 Da
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Activator
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
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Activator
General Function
Serine-type endopeptidase activity
Specific Function
Factor IX is a vitamin K-dependent plasma protein that participates in the intrinsic pathway of blood coagulation by converting factor X to its active form in the presence of Ca(2+) ions, phospholi...
Gene Name
F9
Uniprot ID
P00740
Uniprot Name
Coagulation factor IX
Molecular Weight
51778.11 Da

Drug created at November 18, 2016 20:53 / Updated at April 22, 2024 18:19