ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant clotting factor IX therapy with prolonged circulation in the body, was developed for hemophilia B using Fc fusion technology. It is engineered by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body), enabling ALPROLIX to use a naturally occurring pathway to extend the time the therapy remains in the body (half-life). While Fc fusion technology has been used for more than 15 years, Bioverativ, a Sanofi company, and Sobi have optimized the technology and are the first companies to utilize it in the treatment of hemophilia. ALPROLIX is manufactured using a human cell line in an environment free of animal and human additives.
ALPROLIX is approved for the treatment of hemophilia B in the United States, Canada, Japan, Australia and New Zealand and is marketed by Bioverativ in these regions. It is also approved in the European Union, Iceland, Liechtenstein, Norway and other countries, and is marketed by Sobi in these regions.
Allergic-type hypersensitivity reactions and development of inhibitors have been observed with ALPROLIX in the treatment of hemophilia B, including in previously untreated patients.
For complete U.S. prescribing information, please visit ALPROLIX.com