Fibrinogen human

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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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Used as adjunct in combination to manageBleedingCombination Product in combination with: Human thrombin (DB11571)••••••••••••••••••••••••••• •••••••• •• •••••••••••• ••••••••••••
Used as adjunct in combination to manageBleedingCombination Product in combination with: Human thrombin (DB11571)•••••••••••••••••••••• •••••••• •• •••••••••••• ••••••••••••
Used as adjunct in combination to manageBleedingCombination Product in combination with: Human thrombin (DB11571)•••••••••••••••••••••• •••••••• •• •••••••••••• ••••••••••••
Used in combination to preventBleedingCombination Product in combination with: Aprotinin (DB06692), Thrombin (DB11300), Calcium chloride (DB01164), Antihemophilic factor human (DB13192)••••••••••••••••••••
Used in combination to preventBleedingCombination Product in combination with: Antihemophilic factor human (DB13192), Aprotinin (DB06692), Thrombin (DB11300), Calcium chloride (DB01164)••••••••••••••••••••
Associated Therapies
Contraindications & Blackbox Warnings
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Pharmacodynamics

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
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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.
DrugInteraction
AbciximabThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Abciximab.
AcenocoumarolThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Acenocoumarol.
Alpha-1-proteinase inhibitorThe therapeutic efficacy of Fibrinogen human can be increased when used in combination with Alpha-1-proteinase inhibitor.
AlteplaseThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Alteplase.
Aminocaproic acidThe risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Fibrinogen human.
Food Interactions
No interactions found.

Products

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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
FibrygaPowder, for solution1 g / vialIntravenousOctapharma Pharmazeutika Produktionsges M B H2018-08-08Not applicableCanada flag
FibrygaKit20 mg/1mLIntravenousOctapharma USA Inc2017-10-16Not applicableUS flag
RiaSTAPPowder, for solution1000 mg / vialIntravenousCsl Behring2013-01-31Not applicableCanada flag
RiaSTAPInjection, powder, lyophilized, for solution1300 mg/50mLIntravenousCSL Behring GmbH2009-01-162009-03-17US flag
RiaSTAPInjection, powder, lyophilized, for solution1300 mg/50mLIntravenousCSL Behring GmbH2009-01-16Not applicableUS flag
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
ArtissFibrinogen human (125 mg / mL) + Aprotinin (3000 kiu / mL) + Calcium chloride (40 mcmol / mL) + Human thrombin (4 unit / mL)SolutionTopicalBaxter Laboratories2011-12-18Not applicableCanada flag
ArtissFibrinogen human (90 mg/1mL) + Human thrombin (4 [iU]/1mL)KitTopicalBaxalta US Inc.2008-03-212008-03-21US flag
ARTISS - Lösungen für einen GewebekleberFibrinogen human (45.5 mg/ml) + Aprotinin (1500 KIE/ml) + Calcium chloride (20 μmol/ml) + Thrombin (2 IU/ml)SolutionTopicalBaxter Medical Products Gmb H2009-03-19Not applicableAustria flag
ARTISS 10 ML ÇÖZELTİ İÇEREN KULLANIMA HAZIR ENJEKTOR, 1 ADETFibrinogen human (91 mg/ml) + Aprotinin (3000 KIU/ml) + Calcium chloride dihydrate (40 mcmol/ml) + Thrombin (4 IU/ml)SolutionTopicalBAXTER TURKEY RENAL HİZMETLER A.Ş.2020-08-14Not applicableTurkey flag
ARTISS 2 ML ÇÖZELTİ İÇEREN KULLANIMA HAZIR ENJEKTOR, 1 ADETFibrinogen human (91 mg/ml) + Aprotinin (3000 KIU/ml) + Calcium chloride dihydrate (40 mcmol/ml) + Thrombin (4 IU/ml)SolutionTopicalBAXTER TURKEY RENAL HİZMETLER A.Ş.2020-08-14Not applicableTurkey flag

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
  1. FDA Approved Drug Products: EVITHROM (Human Thrombin), for topical use [Link]
  2. DailyMed Label: VISTASEAL (human fibrinogen, human thrombin) kit, for topical use [Link]
  3. FDA Approved Drug Products: FIBRYGA [fibrinogen (human)] Lyophilized Powder for Reconstitution, For Intravenous Use [Link]
  4. DailyMed Label: EVARREST (fibrinogen human and human thrombin) Fibrin Sealant Absorbable Patch for Topical Use [Link]
  5. DailyMed Label: TACHOSIL (thrombin human and fibrinogen)Fibrin Sealant Absorbable Patch for Topical Use [Link]
PubChem Substance
347910418
RxNav
4385
Drugs.com
Drugs.com Drug Page
Wikipedia
Fibrin_glue

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingTreatmentFibrin Blood Clot1
4CompletedNot AvailableBlood Clotting / Blood Platelet Transfusion1
4CompletedPreventionBleeding Disorders / Fibrinogen Deficiency / Hypofibrinogenemia1
4CompletedPreventionBleeding / Scoliosis; Adolescence / Surgery1
4CompletedPreventionOsteoarthritis (OA)1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SolutionTopical
SolutionTopical360 -
Solution
SolutionParenteral1.50 g
SolutionOther70 mg/ml
SolutionIntralesional; Irrigation
Injection, powder, for solutionParenteral1.5 g
Injection, powder, for solutionParenteral1.5 G/100ML
Powder, for solutionIntravenous
SolutionOther1 G
InjectionIntravenous1 G
KitIntravenous20 mg/1mL
Powder, for solutionIntravenous1 g / vial
Injection, powder, for solutionParenteral1 g
Powder1 g
Injection, powder, lyophilized, for solutionIntravenous1 g
Injection, powder, for solutionParenteral1 g/2g
Injection, powder, lyophilized, for solutionIntravenous1.1 g
PowderTopical
Injection, powder, for solutionParenteral
Injection, powder, lyophilized, for solutionIntravenous1300 mg/50mL
Powder, for solutionIntravenous1000 mg / vial
Powder, for solutionTopical
PatchTopical
SpongeTopical
KitTopical
Kit; solution
Kit; powder, for solutionTopical
SolutionTopical3000 KIU/ml
PowderSoft tissue
SolutionOther80 mg/ml
Kit; solutionTopical
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