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.
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- Contraindications & Blackbox Warnings
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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
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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. Ancrod The therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Ancrod. Anistreplase The therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Anistreplase. Antithrombin Alfa The therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Antithrombin Alfa. Antithrombin III human The therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Antithrombin III human. Apixaban The therapeutic efficacy of Coagulation factor VII human can be decreased when used in combination with Apixaban. 
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- No interactions found.
Products
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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 USA Inc 2023-07-21 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 Beriplex P/N 500 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Coagulation factor VII human (350 IE) + Coagulation Factor IX Human (510 IE) + Coagulation factor X human (820 IE) + Protein C (600 I.E.) + Protein S human (500 IE) + Prothrombin (680 IE) Injection, powder, for solution Parenteral Csl Behring 2008-02-27 Not applicable Austria Cofact 250 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Coagulation factor VII human (135 IE) + Coagulation Factor IX Human (250 IE) + Coagulation factor X human (245 IE) + Prothrombin (245 IE) Injection, powder, for solution Parenteral Prothya Biosolutions Netherlands b.v. 2007-05-18 Not applicable Austria COFACT 250 IU/10 ML IV ENJEKSIYON IÇIN TOZ IÇEREN FLAKON, 1 ADET Coagulation factor VII human (135 IU) + Coagulation Factor IX Human (250 IU) + Coagulation factor X human (245 IU) + Protein C (250 IU) + Protein S human (45 IU) + Prothrombin (245 IU) Injection Intravenous CENTURION İLAÇ SAN. VE TİC. A.Ş. 2020-08-14 Not applicable Turkey 
Cofact 500 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Coagulation factor VII human (270 IE) + Coagulation Factor IX Human (500 IE) + Coagulation factor X human (490 IE) + Prothrombin (490 IE) Injection, powder, for solution Parenteral Prothya Biosolutions Netherlands b.v. 2007-05-18 Not applicable Austria COFACT 500 IU/20 ML IV ENJEKSIYON IÇIN TOZ IÇEREN FLAKON, 1 ADET Coagulation factor VII human (270 IU) + Coagulation Factor IX Human (500 IU) + Coagulation factor X human (490 IU) + Protein C (500 IU) + Protein S human (90 IU) + Prothrombin (490 IU) Injection Intravenous CENTURION İLAÇ SAN. VE TİC. A.Ş. 2020-08-14 Not applicable Turkey
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]
- External Links
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Bleeding / Blood Loss During Surgery / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates 1 4 Completed Treatment Congenital Hematological Disorder / Hemophilia A With Inhibitors / Hemophilia B With Inhibitors 3 4 Recruiting Treatment Coagulation Disorder / Massive Hemorrhage / Traumatic haemorrhage 1 4 Withdrawn Treatment Postpartum Haemorrhage (PPH) 1 3 Completed Treatment Acquired Bleeding Disorder / Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass 1 3 Completed Treatment Acute Major Bleeding / Coagulation Disorder 1 3 Completed Treatment High Bleeding Risk 1 3 Completed Treatment Reversal of Anticoagulant Treatment 1 3 Completed Treatment Reversal of Coagulopathy 1 3 Recruiting Treatment Acute Major Bleeding 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, for solution Intravenous Injection Intravenous Injection, powder, for suspension Parenteral 600 IU Injection, powder, for solution Parenteral 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
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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 May 27, 2021 02:58