It is indicated as an “on-demand” treatment to control bleeding episodes, for the management of bleeding during surgery, and as a routine preventive treatment to reduce the frequency of bleeding episodes.
Bioverativ‘s Alprolix is the first recombinant clotting factor IX therapy with prolonged circulation in the body. It was developed for people with hemophilia B using Fc fusion technology. Fc fusion technology combines factor IX to the Fc portion of immunoglobulin G subclass 1 (IgG1), a protein commonly found in the body. This enables Alprolix to use a naturally occurring pathway to remain longer in the body.
Some proteins in the blood, such as clotting factors, are taken out of the circulation and broken down. Alprolix uses a natural process to delay this breakdown through three steps: binding, redirecting, and recirculating the clotting factor.
The manufacturing of Alprolix follows a very strict process, from the production and purification of protein-producing host cells to viral clearance of the proteins, and to the formulation of the final product in single-use vials as a freeze-dried powder, which needs to be diluted in a liquid that comes in a pre-filled syringe.
The recommended starting treatment dosage for Alprolix is 50 IU/kg once weekly, or 100 IU/kg every 10 days, which can be adjusted based on the response of each patient.
Children under the age of 12 may have higher body weight-adjusted clearance, shorter half-life, and lower recovery of factor IX. Consequently, they may need more frequent administration or a higher dose of the drug.
Common side effects of Alprolix include headache and an abnormal sensation in the mouth.
Alprolix is not indicated for the induction of immune tolerance in patients with hemophilia B.
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