==== Reference: Usmani SS, Bedi G, Samuel JS, Singh S, Kalra S, Kumar P, et al. (2017) THPdb: Database of FDA-approved peptide and protein therapeutics. PLoS ONE 12(7) e0181748.====

Detailed description page of THPdb

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Primary information
ThPP IDTh1180
Therapeutic Peptide/Protein NameFibrinogen Concentrate (Human)
SequenceNA view full sequnce in fasta
Functional ClassificationIa
Molecular Weight340000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting Point (℃)NA
Half Life78.7 ± 18.13 (55.73-117.26) hours
DescriptionFibrinogen Concentrate (Human) is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma.
Indication/DiseaseFor the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
PharmacodynamicsAdministration of fibrinogen concentrate (human) for intravenous use to patients with congenital fibrinogen deficiency replaces the missing, or low coagulation factor. Normal levels are in the range of 200 to 450 mg/dL
Mechanism of ActionFibrinogen (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).2 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.2 The resulting fbrin 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.3 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.
ToxicityNA
MetabolismNA
AbsorptionAUC for dose 70 mg/Kgis 124.3 ± 24.16 (81.73-156.40) mg*hr/mL
Volume of Distribution52.7 ± 7.48 (36.22-67.67) mL/KG
Clearance0.59 ± 0.13 (0.45-0.86) mL/h/KG
CategoriesNA
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionThe risk or severity of adverse effects can be increased when Aminocaproic Acid is combined with Fibrinogen Concentrate (Human); The risk or severity of adverse effects can be increased when Menadione is combined with Fibrinogen Concentrate (Human); The risk or severity of adverse effects can be increased when Phylloquinone is combined with Fibrinogen Concentrate (Human); The risk or severity of adverse effects can be increased when Tranexamic Acid is combined with Fibrinogen Concentrate (Human).
TargetNA
Information of corresponding available drug in the market
Brand NameRiastap
CompanyCsl Behring Gmb H
Brand DiscriptionRiaSTAP (fibrinogen concentrate human for intravenous use) is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma.
Prescribed forRiaSTAPâ„¢ (fibrinogen concentrate (human) for intravenous use) , Fibrinogen Concentrate (Human) is indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.
Chemical NameNA
FormulationEach vial contains 900 to 1300 mg fibrinogen, 400 to 700 mg human albumin, 375 to 660 mg L-arginine hydrochloride, 200 to 350 mg sodium chloride and 50 to 100 mg sodium citrate. Sodium hydroxide and hydrochloric acid may have been used to adjust the pH.
Physcial Appearnceinjection, powder, lyophilized, for solution
Route of AdministrationIV
Recommended DosageDose should be individually calculated for each patient based on the target plasma fibrinogen level based on the type of bleeding, actual measured plasma fibrinogen level and body weight
ContraindicationRiaSTAP (fibrinogen concentrate (human) for intravenous use) is contraindicated in individuals who have manifested severe immediate hypersensitivity reactions, including anaphylaxis to RiaSTAP (fibrinogen concentrate (human) for intravenous use) or its components.
Side EffectsThe most serious adverse reactions that have been reported in clinical studies or through postmarketing surveillance following RiaSTAP (fibrinogen concentrate (human) for intravenous use) treatment are allergic-anaphylactic reactions and thromboembolic episodes, including myocardial infarction, pulmonary embolism, deep vein thrombosis, and arterial thrombosis. The most common adverse reactions that have been reported in clinical studies or through postmarketing surveillance following RiaSTAP (fibrinogen concentrate (human) for intravenous use) treatment are allergic reactions and generalized reactions such as chills, fever, nausea, and vomiting.
Useful Linkhttp://www.rxlist.com/riastap-drug/side-effects-interactions.htm
PubMed ID18179679
3-D StructureN.A.