Coagulation factor VII human
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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
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to treat Vitamin k antagonist induced major bleeding Regimen 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.
Target Actions Organism ATissue factor activatorHumans ACoagulation factor X activatorHumans ACoagulation factor IX activatorHumans - 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
- Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.
- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Abciximab. Acenocoumarol The therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Acenocoumarol. Alpha-1-proteinase inhibitor Alpha-1-proteinase inhibitor may increase the thrombogenic activities of Coagulation factor VII human. Alteplase The therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Alteplase. Aminocaproic acid The 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
- Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.
- Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Balfaxar Coagulation 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 solution Intravenous Octapharma Italy S.P.A. 2023-11-30 Not applicable US Beriplex P/n 1000 Coagulation 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 solution Intravenous Csl Behring 2013-11-21 Not applicable Canada Beriplex P/N 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Coagulation 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 solution Parenteral Csl Behring 2013-04-16 Not applicable Austria Beriplex P/N 250 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Coagulation 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 solution Parenteral Csl Behring 2008-02-27 Not applicable Austria Beriplex P/n 500 Coagulation 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 solution Intravenous Csl Behring 2011-07-28 Not applicable Canada
Categories
- ATC Codes
- B02BD01 — Coagulation factor ix, ii, vii and x in combination
- B02BD — Blood coagulation factors
- B02B — VITAMIN K AND OTHER HEMOSTATICS
- B02 — ANTIHEMORRHAGICS
- B — BLOOD AND BLOOD FORMING ORGANS
- 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
- 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]
- 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]
- Broze GJ Jr, Majerus PW: Purification and properties of human coagulation factor VII. J Biol Chem. 1980 Feb 25;255(4):1242-7. [Article]
- KCENTRA monograph [Link]
- FDA Approved Drug Products: BALFAXAR (prothrombin complex concentrate, human-lans) lyophilized powder for solution, for intravenous use (July 2023) [Link]
- External Links
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Completed Not Available Acquired Bleeding Disorder / Acquired Haemophilia 1 somestatus stop reason just information to hide Not Available Completed Not Available Acquired Bleeding Disorder / Acquired Haemophilia / Congenital FVII Deficiency / Congenital Hematological Disorder / Glanzmann's Thrombasthenia 1 somestatus stop reason just information to hide Not Available Completed Not Available Acquired Bleeding Disorder / Trauma 1 somestatus stop reason just information to hide Not Available Completed Not Available Cardiopulmonary Bypass 1 somestatus stop reason just information to hide Not Available Completed Not Available Congenital FVII Deficiency / Congenital Hematological Disorder 2 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, for solution Intravenous Injection Intravenous Injection, powder, lyophilized, for solution Intravenous 600 IU Injection, powder, lyophilized, for solution Intravenous 60000000 IU Injection, powder, for solution Parenteral 600 I.E. Powder, for solution Intravenous Injection, powder, lyophilized, for solution; kit Intravenous Kit; powder, for solution Intravenous Injection, powder, for solution Intravenous drip 520 IU/vial Injection, powder, for solution Parenteral Injection, powder, lyophilized, for solution Intravenous 200 IU/10ml Injection, powder, lyophilized, for solution Intravenous 500 IU/10ml Powder, for solution Intravenous 200 UI Powder, for solution Intravenous 600 UI - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Yes
- Actions
- Activator
- General 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 proteolysis. TF plays a role in normal hemostasis by initiating the cell-surface assembly and propagation of the coagulation protease cascade
- Specific Function
- cytokine receptor activity
- 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
- 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. Factor Xa activates pro-inflammatory signaling pathways in a protease-activated receptor (PAR)-dependent manner (PubMed:24041930, PubMed:30568593, PubMed:34831181). Up-regulates expression of protease-activated receptors (PARs) F2R, F2RL1 and F2RL2 in dermal microvascular endothelial cells (PubMed:35738824). Triggers the production of pro-inflammatory cytokines, such as MCP-1/CCL2 and IL6, in cardiac fibroblasts and umbilical vein endothelial cells in PAR-1 (F2R)-dependent manner (PubMed:30568593, PubMed:34831181). Triggers the production of pro-inflammatory cytokines, such as MCP-1/CCL2, IL6, TNF-alpha/TNF, IL-1beta/IL1B, IL8/CXCL8 and IL18, in endothelial cells and atrial tissues (PubMed:24041930, PubMed:35738824, PubMed:9780208). Induces expression of adhesion molecules, such as ICAM1, VCAM1 and SELE, in endothelial cells and atrial tissues (PubMed:24041930, PubMed:35738824, PubMed:9780208). Increases expression of phosphorylated ERK1/2 in dermal microvascular endothelial cells and atrial tissues (PubMed:24041930, PubMed:35738824). Triggers activation of the transcription factor NF-kappa-B in dermal microvascular endothelial cells and atrial tissues (PubMed:24041930, PubMed:35738824). Up-regulates expression of plasminogen activator inhibitor 1 (SERPINE1) in atrial tissues (PubMed:24041930)
- Specific Function
- calcium ion binding
- 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
- 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, phospholipids, and factor VIIIa
- Specific Function
- calcium ion binding
- 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