Fibrinogen human

Identification

Name
Fibrinogen human
Accession Number
DB09222
Description

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

Pharmacology

Indication

For the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

Associated Conditions
Associated Therapies
Contraindications & Blackbox Warnings
Learn about our commercial Contraindications & Blackbox Warnings data.
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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
Learn about our commercial Adverse Effects data.
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Toxicity
Not Available
Affected organisms
  • Humans and other mammals
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.
Acetylsalicylic acidThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Acetylsalicylic acid.
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.
AncrodThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Ancrod.
AnistreplaseThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Anistreplase.
Antithrombin AlfaThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Antithrombin Alfa.
Antithrombin III humanThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Antithrombin III human.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
Not Available

Products

Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
FibrygaPowder, for solution1 gIntravenousOctapharma Pharmazeutika Produktionsges M B H2018-08-08Not applicableCanada flag
FibrygaKit20 mg/1mLIntravenousOctapharma USA Inc2017-10-16Not applicableUS flag
RiaSTAPPowder, for solution1000 mgIntravenousCsl 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
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing EndRegionImage
ArtissFibrinogen human (90 mg/1mL) + Human thrombin (4 [iU]/1mL)KitTopicalBaxalta US Inc.2008-03-212008-03-21US flag
ArtissFibrinogen human (125 mg) + Aprotinin (3000 kiu) + Calcium chloride (40 mcmol) + Human thrombin (4 unit)SolutionTopicalBaxter Laboratories2011-12-18Not applicableCanada flag
ARTISS Fibrin SealantFibrinogen human (90 mg/1mL) + Human thrombin (4 [iU]/1mL)SolutionTopicalBaxter Healthcare Corporation2008-03-19Not applicableUS flag
ARTISS FrozenFibrinogen human (90 mg/1mL) + Human thrombin (4 [iU]/1mL)SolutionTopicalBaxalta US Inc.2009-03-192019-06-30US flag
EvarrestFibrinogen human (8.6 mg/1cm2) + Human thrombin (37.5 [iU]/1cm2)PatchTopicalEthicon, Inc.2013-03-01Not applicableUS flag
EvicelFibrinogen human (90 mg) + Human thrombin (1200 unit)Kit; SolutionTopicalOmrix Biopharmaceuticals Ltd2011-03-01Not applicableCanada flag
EVICEL Fibrin Sealant (Human)Fibrinogen human (85 mg/1mL) + Human thrombin (1200 [iU]/1mL)TopicalEthicon Inc2013-03-21Not applicableUS flag
QuixilFibrinogen human (60.0 mg) + Calcium chloride (6.2 mg) + Human thrombin (1200 unit)Kit; SolutionTopicalOmrix Biopharmaceuticals LtdNot applicableNot applicableCanada flag
RaplixaFibrinogen human (79 mg/g) + Human thrombin (726 IU/g)PowderTopicalMallinckrodt Pharmaceuticals Ireland Limited2015-03-19Not applicableEU flag
RaplixaFibrinogen human (79 mg/1g) + Human thrombin (699 [iU]/1g)PowderTopicalMallinckrodt Hospital Products Inc.2015-06-222018-06-14US 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

Chemical Identifiers

UNII
N94833051K
CAS number
9001-32-5

References

General References
  1. FDA label [Link]
PubChem Substance
347910418
RxNav
4385
Drugs.com
Drugs.com Drug Page
Wikipedia
Fibrin_glue
AHFS Codes
  • 20:28.16 — Hemostatics
FDA label
Download (201 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingPreventionCervical Cancers / Cervical Intraepithelial Neoplasia (CIN)1
4CompletedNot AvailableBlood Clotting / Blood Platelet Transfusion1
4CompletedNot AvailableBlood Loss,Surgical1
4CompletedNot AvailableBlood Loss,Surgical / Hemostasis1
4CompletedPreventionBleeding Disorders / Fibrinogen Deficiency / Hypofibrinogenemia1
4CompletedPreventionBleeding / General Surgery / Scoliosis; Adolescence1
4CompletedPreventionOsteoarthritis (OA)1
4CompletedPreventionProstate or Bladder Cancer1
4CompletedTreatmentAspiration / Breast Cancer / Seroma1
4CompletedTreatmentBleeding Disorder / Fibrinogen; Deficiency, Acquired / Trauma; Hemorrhage, Complicating Delivery / Traumas1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SolutionTopical91 mg/ml
SolutionTopical
Solution90 mg/ml
PatchTopical
Kit; solutionTopical
SolutionIntralesional; Irrigation70 mg/mL
KitIntravenous20 mg/1mL
Powder, for solutionIntravenous1 g
InjectionIntravenous1 g
PowderTopical
Injection, powder, lyophilized, for solutionIntravenous1300 mg/50mL
Powder, for solutionIntravenous1000 mg
SpongeTopical5.5 mg/cm^2
KitTopical
Kit; solution91 mg/mL
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Drug created on October 22, 2015 13:51 / Updated on September 27, 2020 08:17

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