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Konyne

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Konyne

CLINICAL PHARMACOLOGY

Factor IX Complex raises the plasma level of factor IX and restores hemostasis in patients with factor IX deficiency. In general, a level of factor IX less than 5% of normal will give rise to spontaneous hemorrhage, while levels greater than 20% of normal will lead to satisfactory hemostasis even in the face of trauma or surgery. Approximately 30% to 50% of the factor IX activity can be detected in a hemophilia B (factor IX deficiency) recipient's plasma immediately after infusion. 1,2 The biological activity of the infused factor IX disappears from the plasma with a half-life of approximately 24 hours. 2 A pharmacokinetic study in six patients found similar recoveries and half-lives for Konyne (factor ix complex) ® 80 as for Konyne®-HT. It must be noted that administration of Factor IX Complex causes an increase in blood levels of factors II, VII, IX and X.

Factors II, VII, IX and X are the vitamin K dependent coagulation factors and are synthesized in the liver. Congenital deficiencies of each of the four factors do occur and may result in a bleeding tendency. Naturally low levels of the vitamin K dependent factors may also be found in vitamin K deficiency and in severe liver disease.

This product has been heated at 80°C for 72 hours and there is no evidence of adverse effects upon the product. In a study 3 designed to assess the effectiveness of heat treatment at 68°C for 72 hours, hepatitis naive chimpanzees were inoculated with heated Antihemophilic Factor (Human) and Factor IX Complex preparations to which had been previously added non-A, non-B hepatitis Hutchinson Strain 4 to a total level of 2500 chimpanzee infectious doses (CID). The chimpanzees receiving heated preparations failed to exhibit any symptoms of non-A, non-B hepatitis. In contrast, one chimpanzee receiving Antihemophilic Factor (Human) concentrate which was not heated after the non-A, non-B inoculum was added, developed abnormally elevated alanine aminotransferase (ALT) levels beginning 10 weeks postinoculation and liver histopathology at 6 weeks. From these results, it was concluded that the heat treatment employed inactivated a known quantity of non-A, non-B hepatitis: at least 2500 CID.

Additional in vitro studies 5 on the effect of heating Factor IX Complex, Konyne (factor ix complex) ® 80, in a dried state at 80°C for 72 hours, on virus inactivation were carried out with a number of viruses, including human immunodeficiency virus (HIV), added to Factor IX Complex prior to heating. The following table shows the amount of each model virus inactivated by the process:

 

Virus
Starting
Amount
Logs *
Logs
Inactivated
Vesicular Stomatitis Virus
8.0  ≥7.5
Vaccinia Virus
5.75 1.0
Sindbis Virus
7.25 ≥6.75
Bovine Parvovirus
4.5  3.5
Human Immunodeficiency Virus (HIV), HIV-1
4.8  ≥4.3
* log 10 TCID 50 /mL (for HIV-1, log 10 TCID 50 )

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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