Octocog Alfa

Therapeutic Octocog Alfa recombinant protein from the original Advate® commercial drug.

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Clotting Factor VIII
Recombinant protein
Advate®
125 IU/mL
25 IU
-80°C
09/2022
904,00 
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Advate® / Octocog Alfa Reference Product

Drug nameAdvate®
INNOctocog Alffa
API typeOctocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 2332 amino acids.
It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. Prepared without the addition of any (exogenous) human- or animal-derived protein in the cell culture process, purification or final formulation.
Pharmacotherapeutic group
Antihemorrhagics, blood coagulation factor VIII
ATC code
B02BD02
Target of antibody
TNF alpha
General functionTreatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII
deficiency). Octocog Alfa is indicated in all age groups.
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
When infused into a haemophilia patient, octocog alfa binds to endogenous 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 to 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 activity and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. The plasma levels of factor VIII are increased by replacement therapy, thereby enabling a temporary correction of the factor VIII deficiency and correction of the bleeding tendency.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)
Original license holder
Takeda Manufacturing Austria AG
Industriestrasse 67
A-1221 Vienna
Austria
Marketing authorisation numbers
EU/1/03/271/001

Marketing authorisation holder
Takeda Manufacturing Austria AG
Industriestrasse 67
A-1221 Vienna
Austria
Name of the manufacturer of the biological active substance
Baxalta Manufacturing Sàrl
Route de Pierre-à-Bot 111
CH-2000 Neuchâtel
Switzerland

Baxalta Manufacturing SARL
Singapore Branch
2A Woodlands Industrial Park D Street 2
Singapore 737779
Singapore
Name and address of the manufacturer(s) responsible for batch releaseBaxalta Belgium Manufacturing SA
Boulevard René Branquart 80
B-7860 Lessines
Belgium
Max shelf life
2 years
Storage conditions
2°C – 8°C
List of excipients
Powder: Mannitol, Sodium chloride, Histidine, Trehalose, Calcium chloride, Trometamol, Polysorbate 80, Glutathione (reduced)
Solvent: Sterilised water for injections
Evidentic Support
+49 (0) 30 959 99 8831

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