"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 RECOMBINATE (antihemophilic factor (recombinant)) rAHF provides an increase in plasma levels of AHF and can temporarily correct the coagulation defect in these patients. Pharmacokinetic studies on sixty-nine (69) patients revealed the circulating mean half- life for rAHF to be 14.6 ± 4.9 hours (n=67), which was not statistically significantly different from plasma-derived HEMOFIL M, Antihemophilic Factor (Human) (AHF) (pdAHF). The mean half- life of HEMOFIL M AHF was 14.7 ± 5.1 hours (n=61). The actual baseline recovery observed with rAHF was 123.9 ± 47.7 IU/dl (n=23) which is significantly higher than the actual HEMOFIL M AHF baseline recovery of 101.7 ± 31.6 IU/dl (n=61). However, the calculated ratio of actual to expected recovery with rAHF (121.2 ± 48.9%) is not different on average from HEMOFIL M AHF (123.4 ± 16.4%).
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 69 patients. These individuals received cumulative amounts of Factor VIII ranging from 20,914 to 1,383,063 IU over the 48- month study. Patie nts were given a total of 17,700 infusions totaling 28,090,769 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 as part of an ongoing study. The study group was comprised of seventy-nine (79) patients, of whom seventy-six (76) had received at least one infusion of rAHF. To date, this cohort has been given 12,209 infusions totaling over 11,277,043 IU rAHF. Hemostasis was appropriately managed in spontaneous bleeding episodes, intracranial hemorrhage and surgical procedures.
Last reviewed on RxList: 2/20/2009
This monograph has been modified to include the generic and brand name in many instances.
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