Simoctocog alfa 1,000unit powder and solvent for solution for injection vials

Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C. The disorder is associated with episodes of recurrent bleeding and profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma [FDA Label].

Factor VIII circulates in the plasma as a hemostatically active protein complex that consists of factor VIII and a large carrier protein von Willebrand factor via a non-covalent binding interaction. This protein complex remains inactive until the coagulation cascade is activated which in turn activates factor VIII to be released from factor VIII/von Willebrand factor complex. Activated factor VIII acts as a cofactor for factor IX-mediated conversion of factor X to activated factor X. Activated factor X is critical in converting prothrombin into thrombin and sequentially, thrombin converts fibrinogen to fibrin for the formation of a blood clot [L1115, FDA Label].

Simoctocog alfa is an antihemophilic factor that circulates as part of a protein complex with coagulant activity. As a replacement therapy, simoctocog alfa serves to restore the normal levels of factor VIII and allow effective blood clot formation in patients with haemophilia A.