Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton. It is a vitamin-K dependent coagulation factor and it is synthesised in the liver. Factor IX is activated by factor XIa in the intrinsic coagulation pathway and by the factor VII/tissue factor complex in the extrinsic pathway. Activated factor IX, in combination with activated factor VIII, activates factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot is formed.
Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
By replacement therapy the plasma levels of factor IX are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
A pharmacokinetic study with 13 patients yielded the following results:
Using a biphasic model the mean initial half-life was 2.2 ± 1.9 h at initial visit and 3.1 ± 2.9 h at month 3, respectively. The mean terminal half-life was calculated as 28.5 ± 12.1 h at initial visit and 30.1 ± 14.7 h at month 3. The incremental recovery of Haemonine was 69.8 ± 21.6 % and 72.2 ± 22.2 % at initial visit and at month 3, respectively. This corresponded to an incremental recovery of 0.015 ± 0.005 IU/ml/IU/kg body weight at initial visit and of 0.016 ± 0.005 IU/ml/IU/kg body weight at month 3. Other pharmacokinetic parameters of Haemonine are: Area under the curve (AUC): about 25 IU · h/ml; Mean residence time (MRT): about 33 h; Clearance: about 200 ml/h.
The preparation contains exclusively human plasma derived proteins, namely high purity coagulation factor IX, which is identical with the endogenous factor IX.
Preclinical studies in an Ames test showed no mutagenic potential of the preparation.
Haemonine was tested for abnormal toxicity and thrombogenic potential in different rabbit models. The results revealed no signs for toxicological or thrombogenic potential.
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