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Identification
- Summary
Fibrinogen human is a hemostatic agent used for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
- Brand Names
- Artiss, Evarrest, Evicel, Fibryga, Riastap, Tachosil, Tisseel, Vistaseal
- Generic Name
- Fibrinogen human
- DrugBank Accession Number
- DB09222
- Background
Fibrinogen concentrate (human) is a hematological agent. It works by replacing a certain protein in the blood that helps with blood clotting. Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. It is a physiological substrate for three enzymes: plasmin, factor XIIIa and thrombin. It is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Protein Based Therapies
Blood factors - Protein Chemical Formula
- Not Available
- Protein Average Weight
- Not Available
- Sequences
- Not Available
- Synonyms
- Coagulation Factor I
- Factor I (fibrinogen)
- Factor I human
- Fibrinogen
- Fibrinogen (human)
- Fibrinogen Concentrate (Human)
- Fibrinogen concentrate human
- Fibrinogen human
- Fibrinogen human plasma-derived
- Fibrinogen, human
- Human fibrinogen
- Human fibrinogen concentrate, pasteurized
Pharmacology
- Indication
Human fibrinogen is used for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
In combination with thrombin, it is used indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.2,1
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used as adjunct in combination to manage Bleeding Combination Product in combination with: Human thrombin (DB11571) •••••••••••• ••••• •••••••••• •••••••• •• •••••••••••• ••••••• ••••• Used as adjunct in combination to manage Bleeding Combination Product in combination with: Human thrombin (DB11571) •••••••••••• •••••••••• •••••••• •• •••••••••••• ••••••• ••••• Used as adjunct in combination to manage Bleeding Combination Product in combination with: Human thrombin (DB11571) •••••••••••• •••••••••• •••••••• •• •••••••••••• ••••••• ••••• Used in combination to prevent Bleeding Combination Product in combination with: Aprotinin (DB06692), Thrombin (DB11300), Calcium chloride (DB01164), Antihemophilic factor human (DB13192) •••••••••••• •••••••• Used in combination to prevent Bleeding Combination Product in combination with: Antihemophilic factor human (DB13192), Aprotinin (DB06692), Thrombin (DB11300), Calcium chloride (DB01164) •••••••••••• •••••••• - Associated Therapies
- Contraindications & Blackbox Warnings
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Fibrinogen replaces the missing, or low coagulation factor.
- Mechanism of action
Fibrinogen (factor I) is a soluble plasma glycoprotein with a molecular weight of about 340 kDa. The native molecule is a dimer and consists of three pairs of polypeptide chains (Aα, Bβ and γ). Fibrinogen is a physiological substrate of three enzymes: thrombin, factor XIIIa, and plasmin. During the coagulation process, thrombin cleaves the Aα and Bβ chains releasing fibrinopeptides A and B (FPA and FPB, respectively). FPA is separated rapidly and the remaining molecule is a soluble fibrin monomer (fibrin I). The slower removal of FPB results in formation of fibrin II that is capable of polymerization that occurs by aggregation of fibrin monomers. The resulting fibrin is stabilized in the presence of calcium ions and by activated factor XIII, which acts as a transglutaminase. Factor XIIIa-induced cross-linking of fibrin polymers renders the fibrin clot more elastic and more resistant to fibrinolysis. Cross-linked fibrin is the end result of the coagulation cascade, and provides tensile strength to a primary hemostatic platelet plug and structure to the vessel wall.
- Absorption
Cmax is 140 mg/dL
- Volume of distribution
Mean volume of distribution is 52.7 mL/kg.
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
78.7 hours
- Clearance
0.59 mL/h/kg
- 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
- 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 Fibrinogen human can be decreased when used in combination with Abciximab. Acenocoumarol The therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Acenocoumarol. Alpha-1-proteinase inhibitor The therapeutic efficacy of Fibrinogen human can be increased when used in combination with Alpha-1-proteinase inhibitor. Alteplase The therapeutic efficacy of Fibrinogen 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 Fibrinogen 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 Fibryga Powder, for solution 1 g / vial Intravenous Octapharma Pharmazeutika Produktionsges M B H 2018-08-08 Not applicable Canada 
Fibryga Kit 20 mg/1mL Intravenous Octapharma USA Inc 2017-10-16 Not applicable US 
RiaSTAP Powder, for solution 1000 mg / vial Intravenous Csl Behring 2013-01-31 Not applicable Canada RiaSTAP Injection, powder, lyophilized, for solution 1300 mg/50mL Intravenous CSL Behring GmbH 2009-01-16 2009-03-17 US RiaSTAP Injection, powder, lyophilized, for solution 1300 mg/50mL Intravenous CSL Behring GmbH 2009-01-16 Not applicable US - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Artiss Fibrinogen human (90 mg/1mL) + Human thrombin (4 [iU]/1mL) Kit Topical Baxalta US Inc. 2008-03-21 2008-03-21 US Artiss Fibrinogen human (125 mg / mL) + Aprotinin (3000 kiu / mL) + Calcium chloride (40 mcmol / mL) + Human thrombin (4 unit / mL) Solution Topical Baxter Laboratories 2011-12-18 Not applicable Canada ARTISS - Lösungen für einen Gewebekleber Fibrinogen human (45.5 mg/ml) + Aprotinin (1500 KIE/ml) + Calcium chloride (20 μmol/ml) + Thrombin (2 IU/ml) Solution Topical Baxter Medical Products Gmb H 2009-03-19 Not applicable Austria 
ARTISS 10 ML ÇÖZELTİ İÇEREN KULLANIMA HAZIR ENJEKTOR, 1 ADET Fibrinogen human (91 mg/ml) + Aprotinin (3000 KIU/ml) + Calcium chloride dihydrate (40 mcmol/ml) + Thrombin (4 IU/ml) Solution Topical BAXTER TURKEY RENAL HİZMETLER A.Ş. 2020-08-14 Not applicable Turkey 
ARTISS 2 ML ÇÖZELTİ İÇEREN KULLANIMA HAZIR ENJEKTOR, 1 ADET Fibrinogen human (91 mg/ml) + Aprotinin (3000 KIU/ml) + Calcium chloride dihydrate (40 mcmol/ml) + Thrombin (4 IU/ml) Solution Topical BAXTER TURKEY RENAL HİZMETLER A.Ş. 2020-08-14 Not applicable Turkey
Categories
- ATC Codes
- B02BB01 — Fibrinogen, human
- 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
- Humans and other mammals
Chemical Identifiers
- UNII
- N94833051K
- CAS number
- 9001-32-5
References
- General References
- FDA Approved Drug Products: EVITHROM (Human Thrombin), for topical use [Link]
- DailyMed Label: VISTASEAL (human fibrinogen, human thrombin) kit, for topical use [Link]
- FDA Approved Drug Products: FIBRYGA [fibrinogen (human)] Lyophilized Powder for Reconstitution, For Intravenous Use [Link]
- DailyMed Label: EVARREST (fibrinogen human and human thrombin) Fibrin Sealant Absorbable Patch for Topical Use [Link]
- DailyMed Label: TACHOSIL (thrombin human and fibrinogen)Fibrin Sealant Absorbable Patch for Topical Use [Link]
- External Links
- PubChem Substance
- 347910418
- 4385
- Drugs.com
- Drugs.com Drug Page
- Wikipedia
- Fibrin_glue
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 data4 Active Not Recruiting Treatment Fibrin Blood Clot 1 somestatus stop reason just information to hide 4 Completed Not Available Blood Clotting / Blood Platelet Transfusion 1 somestatus stop reason just information to hide 4 Completed Prevention Bleeding Disorders / Fibrinogen Deficiency / Hypofibrinogenemia 1 somestatus stop reason just information to hide 4 Completed Prevention Bleeding / Scoliosis; Adolescence / Surgery 1 somestatus stop reason just information to hide 4 Completed Prevention Osteoarthritis (OA) 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Solution Topical Solution Topical 360 - Solution Solution Parenteral 1.50 g Solution Other 70 mg/ml Solution Intralesional; Irrigation Injection, powder, for solution Parenteral 1.5 g Injection, powder, for solution Parenteral 1.5 G/100ML Powder, for solution Intravenous Solution Other 1 G Injection Intravenous 1 G Kit Intravenous 20 mg/1mL Powder, for solution Intravenous 1 g / vial Injection, powder, for solution Parenteral 1 g Powder 1 g Injection, powder, lyophilized, for solution Intravenous 1 g Injection, powder, for solution Parenteral 1 g/2g Injection, powder, lyophilized, for solution Intravenous 1.1 g Powder Topical Injection, powder, for solution Parenteral Injection, powder, lyophilized, for solution Intravenous 1300 mg/50mL Powder, for solution Intravenous 1000 mg / vial Powder, for solution Topical Patch Topical Sponge Topical Kit Topical Kit; solution Kit; powder, for solution Topical Solution Topical 3000 KIU/ml Powder Soft tissue Solution Other 80 mg/ml Kit; solution Topical - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Drug created at October 22, 2015 19:51 / Updated at July 18, 2023 22:56