BeneFix is a coagulation factor created using recombinant DNA technology to replace clotting factor IX to stop or prevent bleeding in people with hemophilia B who do not have enough factor IX of their own.
A new BeneFix feature allows patients currently using the most common dosage strength – 1000 international units (IU) – to use a lower volume of diluent to administer the product, leading to a lower total volume of infused product. BeneFix also offers a new needleless preparation process, eliminating the risk of needlesticks during reconstitution.
“These new features were designed to enable BeneFix patients to spend less time preparing their factor product, to prepare it more safely and to have additional time for themselves,” says Gary Stiles, executive vice president, Wyeth Pharmaceuticals.
The FDA approved the following four product enhancements for BeneFix Coagulation Factor IX: a 2000 IU dosage strength vial, a needleless reconstitution device, a pre-filled diluent syringe and a reduced diluent volume. Wyeth expects to begin offering BeneFix with these new enhancements in mid-2007.