==== 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


Details of Th1195 which contains 1 entries.


Entry 1
(1) Primary information
ID1801
ThPP IDTh1195
Therapeutic Peptide/Protein NameSimoctocog Alfa
SequenceNA view full sequnce in fasta
Functional ClassificationIa
Molecular Weight170000
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting Point (℃)NA
Half Life14.7 ± 10.4 hrs
DescriptionSimoctocog Alfa is a recombinant B-domain deleted (BDD) rFVIII produced in genetically modified human embryonic kidney (HEK) 293F cells. The harvested product is concentrated and purified by a series of chromatography steps. No animal proteins are used in the purification process and no human albumin is used as a stabiliser in the manufacture of Human-cl rhFVIII. Simoctocog Alfa is a glycoprotein consisting of 1440 amino acids with an approximate molecular mass of 170 kDa, comprising the FVIII domains A1-A2 + A3-C1-C2 whereas the B-domain, present in the full-length plasma-derived FVIII, has been deleted and replaced by a 16 amino acid linker.
Indication/DiseaseTreatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
PharmacodynamicsThe factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions. When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient’s circulation. Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby temporarily enabling a correction of the factor VIII deficiency and correction of the bleeding tendencies.
Mechanism of ActionNA
ToxicityNA
MetabolismNA
AbsorptionAUC: 22.6 ± 8.0 hr*IU/ml
Volume of DistributionNA
Clearance3.0 ± 1.2 ml/hr/kg
CategoriesAntihaemorrhagics: blood coagulation factor VIII
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNA
TargetNA
Information of corresponding available drug in the market
Brand NameNuwiq
CompanyOctapharma Pharmazeutika Produktionsges M B H
Brand DiscriptionNA
Prescribed forNA
Chemical Namehuman coagulation factor VIII
Formulation 250 IU
Physcial AppearancePowder and solvent for solution
Route of AdministrationIntravenous infusion
Recommended DosageThe calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by approximately 2% of normal activity or 2 IU/dl.
ContraindicationHypersensitivity to the active substance or to any of the excipients listed in section
Side EffectsHypersensitivity which may include angiooedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing
Useful Linkhttp://ec.europa.eu/health/documents/community-register/2014/20140722129048/anx_129048_en.pdf
PubMed ID28103444, 27899309
3-D StructureN.A.