Fibrinogen human

Identification

Name
Fibrinogen human
Accession Number
DB09222
Type
Biotech
Groups
Approved
Biologic Classification
Protein Based Therapies
Blood factors
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.

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
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
FibrygaKit20 mg/1mLIntravenousOctapharma USA Inc2017-10-16Not applicableUs
FibrygaPowder, for solution1 gIntravenousOctapharma Pharmazeutika Produktionsges M B H2018-08-08Not applicableCanada
RiaSTAPPowder, for solution1000 mgIntravenousCsl Behring2013-01-31Not applicableCanada
RiaSTAPInjection, powder, lyophilized, for solution1300 mg/50mLIntravenousCSL Behring GmbH2009-01-16Not applicableUs
RiaSTAPInjection, powder, lyophilized, for solution1300 mg/50mLIntravenousCSL Behring GmbH2009-01-162009-03-17Us
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 End
ArtissFibrinogen human (90 mg/1mL) + Human thrombin (4 [iU]/1mL)KitTopicalBaxalta US Inc.2008-03-212008-03-21Us
ArtissFibrinogen human (125 mg) + Aprotinin (3000 kiu) + Calcium chloride (40 mcmol) + Human thrombin (4 unit)SolutionTopicalBaxter Laboratories2011-12-18Not applicableCanada
ARTISS Fibrin SealantFibrinogen human (90 mg/1mL) + Human thrombin (4 [iU]/1mL)SolutionTopicalBaxter Healthcare Corporation2008-03-19Not applicableUs
ARTISS FrozenFibrinogen human (90 mg/1mL) + Human thrombin (4 [iU]/1mL)SolutionTopicalBaxalta US Inc.2009-03-192019-06-30Us
EvarrestFibrinogen human (8.6 mg/1cm2) + Human thrombin (37.5 [iU]/1cm2)PatchTopicalEthicon, Inc.2013-03-01Not applicableUs
EvicelFibrinogen human (90 mg) + Human thrombin (1200 unit)Kit; SolutionTopicalOmrix Biopharmaceuticals Ltd2011-03-01Not applicableCanada
EVICEL Fibrin Sealant (Human)Fibrinogen human (85 mg/1mL) + Human thrombin (1200 [iU]/1mL)TopicalEthicon Inc2013-03-21Not applicableUs
QuixilFibrinogen human (60.0 mg) + Calcium chloride (6.2 mg) + Human thrombin (1200 unit)Kit; SolutionTopicalOmrix Biopharmaceuticals LtdNot applicableNot applicableCanada
RaplixaFibrinogen human (79 mg/1g) + Human thrombin (699 [iU]/1g)PowderTopicalProFibrix BV2015-06-222018-08-03Us
RaplixaFibrinogen human (79 mg/g) + Human thrombin (726 IU/g)PowderTopicalMallinckrodt Pharmaceuticals Ireland Limited2015-03-19Not applicableEu
Categories
UNII
N94833051K
CAS number
9001-32-5

Pharmacology

Indication

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

Associated Conditions
Associated Therapies
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.

Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available
Blackbox Warnings

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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

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
(R)-warfarinThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with (R)-warfarin.
(S)-WarfarinThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with (S)-Warfarin.
4-hydroxycoumarinThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with 4-hydroxycoumarin.
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.
AmediplaseThe therapeutic efficacy of Fibrinogen human can be decreased when used in combination with Amediplase.
Aminocaproic acidThe risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Fibrinogen 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

References

General References
  1. FDA label [Link]
External Links
PubChem Substance
347910418
RxNav
4385
Drugs.com
Drugs.com Drug Page
Wikipedia
Fibrin_glue
ATC Codes
B02BB01 — Fibrinogen, human
AHFS Codes
  • 20:28.16 — Hemostatics
FDA label
Download (201 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1WithdrawnPreventionHernia / Hernia, Abdominal / Ventral Hernias1
1WithdrawnTreatmentPterygium / Ulcerative keratitis1
1, 2CompletedDiagnosticDisorders, Blood Coagulation1
1, 2CompletedTreatmentBleeding / Coagulation Disorders / Hemorrhage / Traumas / Traumatic Injuries1
1, 2CompletedTreatmentCongenital Afibrinogenaemia1
1, 2CompletedTreatmentMassive Hemorrhage / Traumas1
1, 2RecruitingPreventionHemorrhage / Traumatic Brain Injury (TBI)1
1, 2RecruitingTreatmentPolytrauma / Traumatic haemorrhage1
1, 2SuspendedTreatmentPostpartum Haemorrhage (PPH)1
2CompletedPreventionBleeding / Complications / Coronary Artery Disease1
2CompletedTreatmentAortic Aneurysms1
2CompletedTreatmentBleeding (Oozing) in Hepatic Resection1
2CompletedTreatmentCardiac Surgical Procedures / Cryoprecipitate / Disorders, Blood Coagulation / Fibrinogen1
2CompletedTreatmentCardiovascular Heart Disease1
2CompletedTreatmentCoagulation Disorders / Hemorrhage / Traumas1
2CompletedTreatmentColorectal Anastomosis1
2CompletedTreatmentCongenital Fibrinogen Deficiency / Fibrinogen Deficiency1
2CompletedTreatmentDura Defects / Pathological Processes in the Posterior Fossa1
2CompletedTreatmentFacial Rhytidectomy (Face-lift)1
2CompletedTreatmentFibrinogen Deficiency1
2CompletedTreatmentGastrointestinal Diseases1
2CompletedTreatmentHemorrhage / Traumas1
2CompletedTreatmentRhinoplasty / Subjects Requesting and Requiring an Open Rhinoplasty1
2CompletedTreatmentHematomas / Seroma1
2RecruitingTreatmentBile Leak / Common Bile Duct Gall Stones / Infection1
2RecruitingTreatmentCoagulation Disorders / Hemorrhage / Pediatrics / Traumas1
2RecruitingTreatmentProximal Aortic Dissection1
2SuspendedTreatmentCerebrospinal Fluid Leaks1
2TerminatedTreatmentCoronary Artery Disease / Heart Valve Disease1
2TerminatedTreatmentSurgical Bleeding1
2, 3CompletedPreventionDura Defects1
2, 3CompletedSupportive CarePostpartum Haemorrhage (PPH)1
2, 3CompletedTreatmentCongenital Afibrinogenaemia / Hypofibrinogenemia, Congenital1
2, 3CompletedTreatmentFibrinogen Deficiency in Complex Cardiac Surgery1
2, 3CompletedTreatmentIntraoperative Bleeding / Osteoarthritis (OA)1
3CompletedOtherBreast Cancer1
3CompletedPreventionCerebrospinal Fluid Leaks2
3CompletedPreventionCervical Cancers / Endometrial Cancer1
3CompletedTreatmentAdjunct to Hemostasis During Vascular Surgery1
3CompletedTreatmentBleeding1
3CompletedTreatmentBlood Loss,Surgical1
3CompletedTreatmentBlood Loss / Hip Fracture1
3CompletedTreatmentCardiac Complication During Procedure1
3CompletedTreatmentCardiac Surgery Requiring Cardiopulmonary Bypass and Median Sternotomy / Cardiopulmonary Bypass / Sternotomy1
3CompletedTreatmentCardiovascular Heart Disease1
3CompletedTreatmentCongenital Fibrinogen Deficiency1
3CompletedTreatmentDeep Partial or Full Thickness Wounds1
3CompletedTreatmentDeficiency; Fibrinogen, Acquired1
3CompletedTreatmentFace Lift / Face-lift / Facial Rhytidectomy1
3CompletedTreatmentHeart Diseases1
3CompletedTreatmentHemorrhage2
3CompletedTreatmentHemorrhage / Soft tissue haemorrhage1
3CompletedTreatmentIntraoperative Complications / Pulmonary Diseases1
3CompletedTreatmentLiver Diseases1
3CompletedTreatmentPostoperative Blood Loss / Surgical Blood Loss1
3CompletedTreatmentSurgical Bleeding1
3Not Yet RecruitingTreatmentArthroplasty, Replacement, Knee1
3RecruitingPreventionShock, Hemorrhagic1
3RecruitingTreatmentBleeding Disorder / Hypofibrinogenemia; Acquired1
3RecruitingTreatmentCongenital Afibrinogenaemia / Hypofibrinogenemia, Congenital1
3RecruitingTreatmentExcessive Bleeding During Surgery1
3RecruitingTreatmentObesity, Morbid1
3RecruitingTreatmentSepsis / Shock, Septic1
3SuspendedPreventionHemostasis1
3TerminatedTreatmentBlood Loss / Bone Tumour1
3TerminatedTreatmentMajor Trauma1
3Unknown StatusPreventionIntraoperative Bleeding1
3WithdrawnTreatmentFibrinogen Deficiency / Hypofibrinogenemia1
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
4CompletedTreatmentBlood Loss1
4CompletedTreatmentCardiovascular Surgery / Hemorrhage / Hemostasis1
4CompletedTreatmentCoagulopathic Bleeding1
4CompletedTreatmentCoagulopathy in Patients Having Thoraco-Abdominal Aneurysm Repair1
4CompletedTreatmentCongenital Heart Disease (CHD)1
4CompletedTreatmentControl of Local Bleeding in Patients Undergoing Prostatectomy1
4CompletedTreatmentDisorders, Blood Coagulation / Hemorrhage1
4CompletedTreatmentHemorrhage / Soft tissue haemorrhage1
4CompletedTreatmentHemostasis / Liver Surgery1
4CompletedTreatmentIncisional Hernias1
4CompletedTreatmentMelanoma, Malignant / Squamous Cell Carcinoma (SCC)1
4CompletedTreatmentPeriodontitis1
4CompletedTreatmentPost-Partum Hemorrhage1
4Not Yet RecruitingPreventionTotal Blood Loss1
4Not Yet RecruitingTreatmentBleeding / Pediatric HD1
4RecruitingPreventionC.Surgical Procedure; Cardiac / Disorders, Blood Coagulation / Hypofibrinogenemia1
4RecruitingPreventionNeoplasms, Pancreatic / Pancreatic Bordeline Tumor / Pancreatic Periampullary Cancer1
4RecruitingTreatmentCSF Leak1
4RecruitingTreatmentControlling Mild to Moderate Bleeding During Surgery1
4RecruitingTreatmentHemorrhage / Hepatic Parenchyma Bleeding / Soft tissue haemorrhage1
4RecruitingTreatmentPalate, Cleft1
4Unknown StatusSupportive CareThrombotic events1
Not AvailableActive Not RecruitingTreatmentMelanoma1
Not AvailableCompletedNot AvailableCongenital Fibrinogen Deficiency1
Not AvailableCompletedNot AvailableHemorrhage1
Not AvailableCompletedNot AvailableHemorrhage / Peripheral Vascular Disease Patient1
Not AvailableCompletedDiagnosticAcute Coagulopathy1
Not AvailableCompletedPreventionArthroplasty, Replacement, Hip / Arthroplasty, Replacement, Knee / Hemorrhage1
Not AvailableCompletedPreventionInguinal Hernias1
Not AvailableCompletedSupportive CareGoitre / Neoplasms, Thyroid1
Not AvailableCompletedTreatmentEsophageal Diseases / Gastric Diseases1
Not AvailableCompletedTreatmentKnee Replacement Surgery / Osteoarthritis of the Knee / Primary Knee Arthroplasty1
Not AvailableCompletedTreatmentMelanoma1
Not AvailableCompletedTreatmentMinor burns1
Not AvailableNot Yet RecruitingNot AvailableCongenital Fibrinogen Deficiency1
Not AvailableNot Yet RecruitingPreventionLeaks, Anastomotic / Malignant Neoplasm of Stomach1
Not AvailableRecruitingNot AvailableBleeding1
Not AvailableRecruitingDiagnosticGood Pasture Syndrome / Humoral Rejection / Hyperviscosity syndrome / Miller Fisher Syndrome / Polyradiculoneuropathy, Chronic Inflammatory Demyelinating1
Not AvailableRecruitingTreatmentFibrinogen; Deficiency, Acquired / Fibrinogenolysis; Hemorrhage / Massive Hemorrhage / Post Partum Hemorrhage / Transfusion Related Complications1
Not AvailableTerminatedSupportive CareBreast Cancer / Perioperative/Postoperative Complications1
Not AvailableTerminatedTreatmentCoagulation Disorders1
Not AvailableTerminatedTreatmentContusions / Recovery Time1
Not AvailableUnknown StatusNot AvailableCompare Ecchymosis and Edema for Fibrin Sealant and no Fibrin Sealant1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
SolutionTopical
PatchTopical
KitIntravenous20 mg/1mL
Powder, for solutionIntravenous1 g
Kit; solutionTopical
PowderTopical
Injection, powder, lyophilized, for solutionIntravenous1300 mg/50mL
Powder, for solutionIntravenous1000 mg
KitTopical
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
Not Available

Taxonomy

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

Drug created on October 22, 2015 13:51 / Updated on June 01, 2020 17:06

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