"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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:
Vesicular Stomatitis Virus
Human Immunodeficiency Virus (HIV), HIV-1
* 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.
Additional Konyne Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.