"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"...
AHF is the specific clotting factor deficient in patients with hemophilia A (classical hemophilia). Hemophilia A is a genetic bleeding disorder characterized by hemorrhages which may occur spontaneously or after minor trauma. The administration of Bioclate (antihemophilic factor) † provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect in these patients.
Pharmacokinetic studies on sixty-six (66) patients revealed the circulating mean half-life for rAHF to be 14.4 ±4.9 hours, which was not statistically significantly different from plasma-derived Antihemophilic Factor (Human), HemofilÒM, (pdAHF), which had a mean half-life of 14.0 ±3.9 hours (n = 59). Mean highest in vivo recovery in plasma was also similar at 2.18 ±0.72 (n = 19) IU/dL per IU/kg body weight compared to the mean highest recovery point above the pre-infusion baseline for HemofilÒM of 1.97 ±0.66 (n = 57) IU/dL per IU/kg.
The clinical study of rAHF in previously treated patients (individuals with hemophilia A who had been treated with plasma derived AHF) was based on observations made on a study group of 67 patients. These individuals received 18,451 to 1,110,111 IU over the 58.2 month study period in 13,394 infusions for a total of 21,437,195 IU rAHF.
These patients were successfully treated for bleeding episodes on a demand basis and also for the prevention of bleeds (prophylaxis). Spontaneous bleeding episodes successfully managed include hemarthroses, soft tissue and muscle bleeds. Management of hemostasis was also evaluated in surgeries. A total of 24 procedures on 13 patients were performed during this study. These included minor (e.g. tooth extraction) and major (e.g. bilateral osteotomies, thoracotomy and liver transplant) procedures. Hemostasis was maintained perioperatively and postoperatively with individualized AHF replacement.
A study of rAHF in previously untreated patients was also performed. The study group comprised seventy-nine (79) patients of whom seventy-five (75) had received at least one infusion of rAHF. In total this cohort has been given 1,054 infusions totalling 437,126 IU rAHF. Hemostasis was appropriately managed in spontaneous bleeding episodes, intracranial hemorrhage and surgical procedures.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Bioclate Information
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