==== 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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1838 details
Primary information
ThPP IDTh1227
Therapeutic Peptide/Protein NameEfmoroctocog alfa
SequenceNA view full sequnce in fasta
Functional ClassificationIb
Molecular WeightNA
Chemical FormulaNA
Isoelectric PointNA
HydrophobicityNA
Melting Point (℃)NA
Half LifeNA
DescriptionEfmoroctocog alfa is a long-acting, fully-recombinant factor VIII Fc fusion protein.
Indication/DiseaseFor the treatment of Haemophilia A.
PharmacodynamicsNA
Mechanism of ActionPatients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily. The active substance in Elocta, efmoroctocog alfa, works in the body in the same way as human factor VIII. It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of bleeding.
ToxicityNA
MetabolismNA
AbsorptionNA
Volume of DistributionNA
ClearanceNA
CategoriesAntihemophilic Factor
Patents NumberNA
Date of IssueNA
Date of ExpiryNA
Drug InteractionNo interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.
TargetNA
Information of corresponding available drug in the market
Brand NameELOCTA
CompanyNA
Brand DiscriptionEfmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc)) has 1890 amino acids. It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line without the addition of any exogenous human- or animal-derived protein in the cell culture process, purification or final formulation.
Prescribed forTreatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
Chemical NameNA
Formulation0.6 mmol (or 14 mg) sodium per vial
Physcial AppearncePowder and solvent for solution for injection
Route of AdministrationIntravenous
Recommended DosageThe calculation of the required dose of recombinant factor VIII Fc is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL. The required dose is determined using the following formula: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL)
ContraindicationHypersensitivity to the active substance (recombinant human coagulation factor VIII, and/or Fc domain)
Side EffectsHypersensitivity or allergic reactions (which may include swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hypotension, lethargy, nausea, restlessness, tachycardia) have been observed rarely and may in some cases progress to severe anaphylaxis.
Useful Linkhttp://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003964/WC500198642.pdf
PubMed ID27487799
3-D StructureN.A.