Identification
- Summary
Coagulation factor VIIa Recombinant Human is a form of recombinant human coagulation Factor VII used to treat hemophilia A and B.
- Brand Names
- Niastase RT, Novoseven, Sevenfact
- Generic Name
- Coagulation factor VIIa Recombinant Human
- DrugBank Accession Number
- DB00036
- Background
Recombinant human coagulation Factor VIIa (rFVIIa), intended for promoting hemostasis by activating the extrinsic pathway of the coagulation cascade. NovoSeven is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues. Cloned and expressed in hamster kidney cells, the protein is catalytically active in a two-chain form.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Blood factors - Protein Structure
- Protein Chemical Formula
- C1972H3076N560O597S28
- Protein Average Weight
- 45079.1 Da
- Sequences
>DB00036 sequence ANAFLEELRPGSLERECKEEQCSFEEAREIFKDAERTKLFWISYSDGDQCASSPCQNGGS CKDQLQSYICFCLPAFEGRNCETHKDDQLICVNENGGCEQYCSDHTGTKRSCRCHEGYSL LADGVSCTPTVEYPCGKIPILEKRNASKPQGRIVGGKVCPKGECPWQVLLLVNGAQLCGG TLINTIWVVSAAHCFDKIKNWRNLIAVLGEHDLSEHDGDEQSRRVAQVIIPSTYVPGTTN HDIALLRLHQPVVLTDHVVPLCLPERTFSERTLAFVRFSLVSGWGQLLDRGATALELMVL NVPRLMTQDCLQQSRKVGDSPNITEYMFCAGYSDGSKDSCKGDSGGPHATHYRGTWYLTG IVSWGQGCATVGHFGVYTRVSQYIEWLQKLMRSEPRPGVLLRAPFP
Download FASTA Format- Synonyms
- Coagulation factor VIIa
- Coagulation factor VIIa (recombinant)
- Coagulation factor VIIa (recombinant)-jncw
- Eptacog alfa
- Eptacog alfa (activated)
- rFVIIa
Pharmacology
- Indication
For treatment of hemorrhagic complications in hemophilia A and B.
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 Prevention of Bleeding •••••••••••• ••••• •••••••• •••••••••• ••••••••• Treatment of Bleeding •••••••••••• ••••• •••••••• •••••••••• ••••••••• Prevention of Bleeding •••••••••••• ••••••••••• •••••••••••••• ••••••••• Prevention of Bleeding •••••••••••• ••••• ••••••••••• •••••••••• • ••••••••• Treatment of Bleeding •••••••••••• ••••• ••••••••••• •••••••••• • ••••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
Used in the treatment of bleeding episodes in hemophilia A or B. NovoSeven is recombinant Factor VIIa and, when complexed with tissue factor can activate coagulation Factor X to Factor Xa, as well as coagulation Factor IX to Factor IXa. Factor Xa, in complex with other factors, then converts prothrombin to thrombin, which leads to the formation of a hemostatic plug by converting fibrinogen to fibrin and thereby inducing local clotting.
- Mechanism of action
NovoSeven activates the coagulation or clotting cascade by cleaving Factor IX and Factor X, which activates them and then leads to activation of thrombin and fibrin.
Target Actions Organism UCoagulation factor X Not Available Humans UTissue factor Not Available Humans UTissue factor pathway inhibitor Not Available Humans UVitamin K-dependent gamma-carboxylase Not Available Humans UCoagulation factor VII Not Available Humans - Absorption
Not Available
- Volume of distribution
- 121 ± 30 mL/kg [adults]
- 153 ± 29 mL/kg [children]
- 280 to 290 mL/kg [congenital Factor VII deficiency]
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
- 33 - 37 mL/h x kg [healthy]
- 1375 +/- 396 mL/hr [severe hemophilia A male children]
- 57.3 +/- 9.5 mL/hr/kg [severe hemophilia A male children]
- 2767 +/- 385 mL/hr [severe hemophilia A men]
- 37.6 +/- 13.1 mL/hr/kg [severe hemophilia A men]
- 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
Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs Browse all" title="About SNP Mediated Effects/ADRs" id="snp-actions-info" class="drug-info-popup" href="javascript:void(0);">
- Not Available
Interactions
- Drug Interactions Learn More" title="About Drug Interactions" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">
- 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 VIIa Recombinant Human can be decreased when used in combination with Abciximab. Acenocoumarol The therapeutic efficacy of Coagulation factor VIIa Recombinant 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 VIIa Recombinant Human. Alteplase The therapeutic efficacy of Coagulation factor VIIa Recombinant 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 VIIa Recombinant 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.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Cevenfacta Injection, powder, for solution 45 KIU Intravenous Laboratoire Francais Du Fractionnement Et Des Biotechnologies 2023-02-08 Not applicable EU 
Cevenfacta Injection, powder, for solution 225 KIU Intravenous Laboratoire Francais Du Fractionnement Et Des Biotechnologies 2023-02-08 Not applicable EU Cevenfacta Injection, powder, for solution 90 KIU Intravenous Laboratoire Francais Du Fractionnement Et Des Biotechnologies 2023-02-08 Not applicable EU Niastase Powder, for solution 4.8 mg / vial Intravenous Novo Nordisk 1999-08-05 2013-07-22 Canada 
Niastase Powder, for solution 2.4 mg / vial Intravenous Novo Nordisk 1999-08-05 2013-07-22 Canada
Categories
- ATC Codes
- B02BD08 — Coagulation factor viia
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Biological Factors
- Blood and Blood Forming Organs
- Blood Coagulation Factors
- Blood Proteins
- Endopeptidases
- Enzymes
- Enzymes and Coenzymes
- Factor VII
- Factor VIIa, antagonists & inhibitors
- Hemostatics
- Hydrolases
- Increased Coagulation Factor IX Activity
- Increased Coagulation Factor X Activity
- Peptide Hydrolases
- Proteins
- Serine Endopeptidases
- Serine Proteases
- 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
- AC71R787OV
- CAS number
- 102786-61-8
References
- General References
- Blackshear PJ, Holloway PA, Alberti KG: Factors regulating amino acid release from extrasplanchnic tissues in the rat. Interactions of alanine and glutamine. Biochem J. 1975 Sep;150(3):379-87. [Article]
- Roberts HR, Monroe DM, White GC: The use of recombinant factor VIIa in the treatment of bleeding disorders. Blood. 2004 Dec 15;104(13):3858-64. Epub 2004 Aug 24. [Article]
- Kenet G, Walden R, Eldad A, Martinowitz U: Treatment of traumatic bleeding with recombinant factor VIIa. Lancet. 1999 Nov 27;354(9193):1879. [Article]
- O'Connell KA, Wood JJ, Wise RP, Lozier JN, Braun MM: Thromboembolic adverse events after use of recombinant human coagulation factor VIIa. JAMA. 2006 Jan 18;295(3):293-8. [Article]
- Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T: Recombinant activated factor VII for acute intracerebral hemorrhage. N Engl J Med. 2005 Feb 24;352(8):777-85. [Article]
- FDA Approved Drug Products: SEVENFACT [coagulation factor VIIa (recombinant)-jncw] Lyophilized Powder for Solution, for Intravenous Use [Link]
- Health Canada Product Monograph: NiaStase RT (eptacog alfa (activated) ) powder for injection [Link]
- External Links
- UniProt
- P08709
- Genbank
- M13232
- KEGG Drug
- D00172
- KEGG Compound
- C03378
- PubChem Substance
- 46507544
- 253149
- PharmGKB
- PA164748389
- RxList
- RxList Drug Page
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Factor_VII
Clinical Trials
- Clinical Trials Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">
Phase Status Purpose Conditions Count 4 Completed Treatment Congenital Hematological Disorder / Hemophilia A With Inhibitors / Hemophilia B With Inhibitors 1 4 Completed Treatment Hemophilia A 1 4 Completed Treatment Hereditary Factor VIII Deficiency Disease With Inhibitor 1 4 Completed Treatment Postpartum Haemorrhage (PPH) 1 4 Recruiting Treatment Hemophilia A With Inhibitors / Hemophilia B With Inhibitors 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Novo Nordisk Inc.
- Dosage Forms
Form Route Strength Injection, powder, for solution Intravenous 225 KIU Injection, powder, for solution Intravenous 45 KIU Injection, powder, for solution Intravenous 5 mg Injection, powder, for solution Intravenous 90 KIU Powder, for solution Intravenous 1.2 mg / vial Powder, for solution Intravenous 2.4 mg / vial Powder, for solution Intravenous 4.8 mg / vial Kit; powder, for solution Intravenous 1 mg / vial Kit; powder, for solution Intravenous 2 mg / vial Kit; powder, for solution Intravenous 5 mg / vial Kit; powder, for solution Intravenous 8 mg / vial Injection, powder, for solution Intravenous 100 KIU Injection, powder, for solution Intravenous 250 KIU Injection, powder, for solution Intravenous 400 KIU Injection, powder, for solution Intravenous 50 KIU Injection, powder, for solution Intravenous bolus 1 MG Injection, powder, for solution Intravenous bolus 2 MG Injection, powder, for solution Intravenous bolus 5 MG Injection, powder, for solution Intravenous bolus 8 MG Injection, powder, lyophilized, for solution Intravenous 1.2 mg Injection, powder, lyophilized, for solution Intravenous 2.4 mg Injection, powder, lyophilized, for solution Intravenous 4.8 mg Injection, powder, lyophilized, for solution Intravenous Injection, powder, for solution Injection, powder, lyophilized, for solution; kit Intravenous 1 mg/1mL Injection, powder, lyophilized, for solution Intravenous 1 mg Injection Intravenous 1 mg Injection Intravenous 2 mg Injection Intravenous Injection, powder, for solution Intravenous 1 mg Injection, powder, for solution Intravenous 2 mg Injection, powder, lyophilized, for solution Intravenous 2 mg Injection, powder, lyophilized, for solution Intravenous 5 mg Injection, powder, lyophilized, for solution; kit Intravenous 5 mg/1mL Solution Intravenous 1.000 mg Powder 1 mg/ml - Prices
Unit description Cost Unit Novoseven 1200 mcg vial 1.64USD vial Novoseven 2400 mcg vial 1.64USD vial Novoseven 4800 mcg vial 1.64USD vial DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only.- Patents
- Not Available
Properties
- State
- Liquid
- Experimental Properties
Property Value Source melting point (°C) 58 °C Petersen, L.C. et al., Eur. J. Biochem 261: 124-129 (1999) hydrophobicity -0.311 Not Available isoelectric point 6.09 Not Available
Targets
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- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- 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
- Malinvaud G: [Reflections on the use of PPSB fraction (Prothrombin-proconvertin-Stuart factor-antihemophilic factor B)]. Transfusion (Paris). 1966;9(3):245-54. [Article]
- BLATRIX C, SOULIER JP: [Preparation of a fraction rich in prothrombin, proconvertin, Stuart factor and antihemophilic factor B (P.P.B. fraction)]. Pathol Biol (Paris). 1959 Dec;7:2477-86. [Article]
- HERMANSKY F, VITEK J: The role of proconvertin and Stuart factor in the inactivation of tissue thromboplastin by serum. Experientia. 1960 Oct 15;16:455-6. [Article]
- GAERTNER H, CAEN J: [FUNCTIONAL RELATION BETWEEN ERYTHROPLASTIN (ERYTHROCYTE COAGULANT FACTOR) AND PLASMA FACTORS: PROACCELERIN (V), PROCONVERTIN (VII) AND STUART FACTOR(X)]. Acta Physiol Pol. 1964 Mar-Apr;15:237-43. [Article]
- DIDISHEIM P, LOEB J, BLATRIX C, SOULIER JP: Preparation of a human plasma fraction rich in prothrombin, proconvertin, Stuart factor, and PTC and a study of its activity and toxicity in rabbits and man. J Lab Clin Med. 1959 Feb;53(2):322-30. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- 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
References
- HERMANSKY F, VITEK J: The role of proconvertin and Stuart factor in the inactivation of tissue thromboplastin by serum. Experientia. 1960 Oct 15;16:455-6. [Article]
- Rogers KS, Barton CL, Benson PA, Green RA: Effects of single-dose L-asparaginase on coagulation values in healthy dogs and dogs with lymphoma. Am J Vet Res. 1992 Apr;53(4):580-4. [Article]
- Christensen NJ: Measurements of some blood clotting factors using a centrifugal analyser (Multistat III). Scand J Clin Lab Invest. 1983 Oct;43(6):521-6. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Serine-type endopeptidase inhibitor activity
- Specific Function
- Inhibits factor X (X(a)) directly and, in a Xa-dependent way, inhibits VIIa/tissue factor activity, presumably by forming a quaternary Xa/LACI/VIIa/TF complex. It possesses an antithrombotic action...
- Gene Name
- TFPI
- Uniprot ID
- P10646
- Uniprot Name
- Tissue factor pathway inhibitor
- Molecular Weight
- 35014.835 Da
References
- Mine S, Yamazaki T, Miyata T, Hara S, Kato H: Structural mechanism for heparin-binding of the third Kunitz domain of human tissue factor pathway inhibitor. Biochemistry. 2002 Jan 8;41(1):78-85. [Article]
- Narita M, Bu G, Olins GM, Higuchi DA, Herz J, Broze GJ Jr, Schwartz AL: Two receptor systems are involved in the plasma clearance of tissue factor pathway inhibitor in vivo. J Biol Chem. 1995 Oct 20;270(42):24800-4. [Article]
- Stassens P, Bergum PW, Gansemans Y, Jespers L, Laroche Y, Huang S, Maki S, Messens J, Lauwereys M, Cappello M, Hotez PJ, Lasters I, Vlasuk GP: Anticoagulant repertoire of the hookworm Ancylostoma caninum. Proc Natl Acad Sci U S A. 1996 Mar 5;93(5):2149-54. [Article]
- Lee AY, Vlasuk GP: Recombinant nematode anticoagulant protein c2 and other inhibitors targeting blood coagulation factor VIIa/tissue factor. J Intern Med. 2003 Oct;254(4):313-21. [Article]
- Hansen CB, Pyke C, Petersen LC, Rao LV: Tissue factor-mediated endocytosis, recycling, and degradation of factor VIIa by a clathrin-independent mechanism not requiring the cytoplasmic domain of tissue factor. Blood. 2001 Mar 15;97(6):1712-20. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Gamma-glutamyl carboxylase activity
- Specific Function
- Mediates the vitamin K-dependent carboxylation of glutamate residues to calcium-binding gamma-carboxyglutamate (Gla) residues with the concomitant conversion of the reduced hydroquinone form of vit...
- Gene Name
- GGCX
- Uniprot ID
- P38435
- Uniprot Name
- Vitamin K-dependent gamma-carboxylase
- Molecular Weight
- 87560.065 Da
References
- Overington JP, Al-Lazikani B, Hopkins AL: How many drug targets are there? Nat Rev Drug Discov. 2006 Dec;5(12):993-6. [Article]
- Imming P, Sinning C, Meyer A: Drugs, their targets and the nature and number of drug targets. Nat Rev Drug Discov. 2006 Oct;5(10):821-34. [Article]
- Bouwman CA, Van Dam E, Fase KM, Koppe JG, Seinen W, Thijssen HH, Vermeer C, Van den Berg M: Effects of 2,3,7,8-tetrachlorodibenzo-p-dioxin or 2,2',4,4',5,5'-hexachlorobiphenyl on vitamin K-dependent blood coagulation in male and female WAG/Rij-rats. Chemosphere. 1999 Feb;38(3):489-505. [Article]
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- General Function
- Serine-type peptidase activity
- Specific Function
- Initiates the extrinsic pathway of blood coagulation. Serine protease that circulates in the blood in a zymogen form. Factor VII is converted to factor VIIa by factor Xa, factor XIIa, factor IXa, o...
- Gene Name
- F7
- Uniprot ID
- P08709
- Uniprot Name
- Coagulation factor VII
- Molecular Weight
- 51593.465 Da
References
- Perera L, Darden TA, Pedersen LG: Probing the structural changes in the light chain of human coagulation factor VIIa due to tissue factor association. Biophys J. 1999 Jul;77(1):99-113. [Article]
- Shapiro A: Inhibitor treatment: state of the art. Semin Hematol. 2001 Oct;38(4 Suppl 12):26-34. [Article]
- Shapiro A: Inhibitor treatment: state of the art. Dis Mon. 2003 Jan;49(1):22-38. [Article]
- Siddiqui MA, Scott LJ: Recombinant factor VIIa (Eptacog Alfa): a review of its use in congenital or acquired haemophilia and other congenital bleeding disorders. Drugs. 2005;65(8):1161-77. [Article]
- Rizoli SB, Chughtai T: The emerging role of recombinant activated Factor VII (rFVIIa) in the treatment of blunt traumatic haemorrhage. Expert Opin Biol Ther. 2006 Jan;6(1):73-81. [Article]
Drug created at June 13, 2005 13:24 / Updated at February 20, 2024 23:54