Coagulation factor VII human

Identification

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Name
Coagulation factor VII human
Accession Number
DB13150
Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Blood factors
Description

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

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
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
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
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
Feiba Vh Immuno Anti InhibitorCoagulation factor VII human + Antihemophilic factor human (4 unit) + Coagulation factor X human + Factor IX Complex (Human) + ProthrombinPowder, for solutionIntravenousOsterreichisches Institut Fur Haemoderivate Ges M.B.H.1986-12-311998-08-13Canada
KcentraCoagulation factor VII human (350 U/20mL) + Coagulation Factor IX Human (510 U/20mL) + Coagulation factor X human (760 U/20mL) + Protein C (620 U/20mL) + Protein S human (460 U/20mL) + Prothrombin (590 U/20mL)KitIntravenousCSL Behring GmbH2013-04-29Not applicableUs
KcentraCoagulation factor VII human (700 U/40mL) + Coagulation Factor IX Human (1020 U/40mL) + Coagulation factor X human (1520 U/40mL) + Protein C (1240 U/40mL) + Protein S human (920 U/40mL) + Prothrombin (1180 U/40mL)KitIntravenousCSL Behring GmbH2013-12-13Not applicableUs
OctaplexCoagulation factor VII human (480 unit) + Coagulation Factor IX Human (500 unit) + Coagulation factor X human (600 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
OctaplexCoagulation factor VII human (960 unit) + Coagulation Factor IX Human (1000 unit) + Coagulation factor X human (1200 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
Categories
UNII
4156XVB4QD
CAS number
Not Available

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.

Associated Conditions
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
Additional Data Available
Adverse Effects

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Contraindications

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Blackbox Warnings

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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

Toxicity

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

Affected organisms
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
(R)-warfarinThe therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with (R)-warfarin.
(S)-WarfarinThe therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with (S)-Warfarin.
4-hydroxycoumarinThe therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with 4-hydroxycoumarin.
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.
Acetylsalicylic acidThe therapeutic efficacy of Coagulation factor VII 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 VII human.
AlteplaseThe therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Alteplase.
AmediplaseThe therapeutic efficacy of Coagulation factor VII 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 VII human.
Additional Data Available
  • Extended Description
    Extended Description

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  • Severity
    Severity

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  • Evidence Level
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  • Action
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Food Interactions
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. [PubMed:11198768]
  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. [PubMed:26714677]
  3. Broze GJ Jr, Majerus PW: Purification and properties of human coagulation factor VII. J Biol Chem. 1980 Feb 25;255(4):1242-7. [PubMed:7354023]
  4. KCENTRA monograph [Link]
External Links
PubChem Substance
347911434

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedDiagnosticCongenital Hematological Disorder / Haemophilia A With Inhibitors / Haemophilia B With Inhibitors1
1CompletedTreatmentAcquired Bleeding Disorder / Acquired Haemophilia / Congenital FVII Deficiency / Congenital Hematological Disorder / Glanzmann's Disease / Haemophilia A With Inhibitors / Haemophilia B With Inhibitors / Healthy Volunteers1
1CompletedTreatmentCongenital Hematological Disorder / Haemophilia A With Inhibitors / Haemophilia B With Inhibitors / Healthy Volunteers1
1CompletedTreatmentCongenital Hematological Disorder / Haemophilia B / Hemophilia A2
1CompletedTreatmentCongenital Hematological Disorder / Healthy Volunteers1
1CompletedTreatmentHealthy Volunteers1
1CompletedTreatmentHealthy Volunteers / Hemostasis1
1CompletedTreatmentHemophilia A / Hereditary factor IX deficiency1
1CompletedTreatmentThrombotic events1
1TerminatedTreatmentHealthy Volunteers / Hemostasis1
1TerminatedTreatmentIntracranial Hemorrhages1
1WithdrawnTreatmentCongenital Hematological Disorder / Haemophilia A With Inhibitors / Haemophilia B / Haemophilia B With Inhibitors / Healthy Volunteers / Hemophilia A1
2CompletedTreatmentAcquired Bleeding Disorder / Bleeding During/Following Surgery2
2CompletedTreatmentAcquired Bleeding Disorder / Cerebral Hemorrhage4
2CompletedTreatmentAcquired Bleeding Disorder / Dengue Hemorrhagic Fever1
2CompletedTreatmentAcquired Bleeding Disorder / Fusion of Spine (Disease)1
2CompletedTreatmentAcquired Bleeding Disorder / Liver Cirrhosis2
2CompletedTreatmentAcquired Bleeding Disorder / Traumas3
2CompletedTreatmentCerebral Hemorrhage1
2CompletedTreatmentCongenital Hematological Disorder / Haemophilia A With Inhibitors / Haemophilia B With Inhibitors1
2CompletedTreatmentHaemorrhagic Cystitis / Other Haemostasis Disorder1
2Not Yet RecruitingTreatmentTrauma Injury1
2RecruitingOtherBleeding in Cardiac Surgery1
2TerminatedTreatmentAcquired Bleeding Disorder / Bleeding During/Following Surgery1
2TerminatedTreatmentAcquired Bleeding Disorder / Cardiac Surgery Requiring Cardiopulmonary Bypass1
2Unknown StatusTreatmentHemophilia A With Inhibitors1
3CompletedTreatmentAcquired Bleeding Disorder / Cardiac Surgery Requiring Cardiopulmonary Bypass1
3CompletedTreatmentAcute Major Bleeding / Disorders, Blood Coagulation1
3CompletedTreatmentReversal of Anticoagulant Treatment1
3CompletedTreatmentReversal of Coagulopathy1
3Not Yet RecruitingTreatmentCerebral Hemorrhage1
3RecruitingTreatmentCongestive Heart Failure / Heart Disease End Stage1
3RecruitingTreatmentSignificant Bleeding Risk1
3Unknown StatusTreatmentCoronary Artery Disease / Disorders, Blood Coagulation / Heart Valve Diseases / Myocardial Ischemia1
3WithdrawnTreatmentAcquired Bleeding Disorder / Traumas1
4CompletedTreatmentCongenital Hematological Disorder / Haemophilia A With Inhibitors / Haemophilia B With Inhibitors3
4Enrolling by InvitationTreatmentBleeding / Blood Loss,Surgical / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates1
4WithdrawnTreatmentPostpartum Haemorrhage (PPH)1
Not AvailableCompletedNot AvailableAcquired Bleeding Disorder / Acquired Haemophilia1
Not AvailableCompletedNot AvailableAcquired Bleeding Disorder / Acquired Haemophilia / Congenital FVII Deficiency / Congenital Hematological Disorder / Glanzmann's Disease1
Not AvailableCompletedNot AvailableAcquired Bleeding Disorder / Traumas1
Not AvailableCompletedNot AvailableCardiopulmonary Bypass1
Not AvailableCompletedNot AvailableCongenital FVII Deficiency / Congenital Hematological Disorder2
Not AvailableCompletedNot AvailableCongenital Hematological Disorder / Glanzmann's Disease2
Not AvailableCompletedNot AvailableCongenital Hematological Disorder / Haemophilia A With Inhibitors / Haemophilia B With Inhibitors3
Not AvailableCompletedNot AvailableCongenital Hematological Disorder / Haemophilia B / Hemophilia A3
Not AvailableCompletedNot AvailableHemorrhage1
Not AvailableCompletedNot AvailableMassive Blood Loss / Massive Blood Transfusion; Thrombocytopenia / Massive Hemorrhage1
Not AvailableCompletedNot AvailableCongenital Factor VII deficiency1
Not AvailableRecruitingNot AvailableHemorrhage1
Not AvailableWithdrawnTreatmentIntracranial Hemorrhage, Spontaneous / Intracranial Hemorrhage, Traumatic1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
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

Targets

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 on November 18, 2016 13:53 / Updated on December 02, 2019 09:50