BeneFix is a recombinant coagulation factor IX, a blood coagulation factor for people with hemophilia B. It can be used to control and prevent bleeding episodes and in surgical management. It has been used in the clinic since the late ’90s.
It is not indicated for the treatment of hemophilia caused by other factor deficiencies (factors II, VII, VIII, and X), the treatment of hemophilia A with inhibitors to factor VIII, reversal of anticoagulation effect induced by coumarin medicines (warfarin), and treatment of bleeding due to low levels of liver-dependent coagulation factors.
How BeneFix works
The recombinant coagulation factor IX is a protein made of recombinant DNA, the structure and function of which are comparable to the naturally occurring factor IX. Factor IX is part of the coagulation cascade and is activated by either factor VII and tissue factor complex or factor XIa. When activated, in combination with activated factor VIII, it activates factor X, leading to the conversion of prothrombin to thrombin. Thrombin then converts fibrinogen into fibrin and a blood clot is formed.
Several studies to assess the efficacy and safety of BeneFix have been conducted. The benefits of the drug have been studied in both previously treated and untreated patients and established as both on-demand and preventive care. Additionally, it has been shown to help control bleeds in major and minor surgeries.
BeneFix was approved by the U.S. Food and Drug Administration in February 1997, and in the European Union later that year.
Common side effects of BeneFix include nausea, injection site reactions, injection site pain, headache, dizziness, and rash.
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