The U.S. Food and Drug Administration (FDA) approved Recombinate for the treatment of hemophilia A in 1992.
How Recombinate works
Factor VIII plays an important part in the hemostasis pathway that regulates the formation of blood clots. Deficiency in factor VIII leads to hemophilia A, symptoms of which can vary from mild to severe depending on the amount of factor VIII present in the blood.
Recombinate is a form of factor VIII that is synthesized in vitro (in the lab) in genetically engineered Chinese hamster ovary (CHO) cells. It is structurally and functionally similar to naturally occurring human factor VIII. It is produced by the CHO cells in the culture medium from where it is collected, purified, and formulated as a powder.
Recombinate can compensate for missing human factor VIII whenever bleeding episodes occur. The amount of Recombinate that needs to be given varies depending on the extent of bleeding.
Recombinate in clinical trials
An open-label, multicenter study over a 48-month period that included 69 patients who were previously treated with plasma-derived factor VIII showed that Recombinate treatment could successfully control bleeding into joints and muscles.
Another multicenter study tested the safety and efficacy of Recombinate in previously untreated patients with hemophilia A. During the study, a total of 79 patients received over 11,277,043 IU of Recombinate over a four-year period. The results showed that Recombinate is well-tolerated and has similar clinical efficacy as plasma-derived human factor VIII in controlling blood loss.
Recombinate is supplied in five different doses ranging from 250 IU to 2,000 IU. Intravenous infusion of Recombinate can be performed at a healthcare center or at home after proper training.
Recombinate should not be used if the patient is allergic to proteins of mouse, hamster, or bovine origin, or if they are allergic to any of the other constituents of the product including calcium, histidine, human albumin, polyethylene glycol (PEG), polysorbate-80, and sodium.
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