Rixubis (recombinant coagulation factor IX, or rFIX) is a drug marketed by Baxter to treat adults and children with hemophilia B. It was the first rFIX product to be approved by the U.S. Food and Drug Administration (FDA) to control and prevent bleeding episodes, and for routine use to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B.
How Rixubis works
Factor IX is a key player in the coagulation cascade, a serious of chain reactions that culminate in the formation of fibrin — the protein that clumps together to form a blood clot when a blood vessel is injured. Without enough functional factor IX, clots are slower to form. That leads to frequent or prolonged bleeding episodes.
Rixubis, known as a factor IX replacement therapy, replaces the deficient or missing factor IX to promote clotting and prevent or reduce bleeding episodes.
Rixubis in clinical trials
The FDA approved Rixubis in June 2013 for hemophilia B patients ages 16 or older based on clinical trials that proved its safety and effectiveness.
A pivotal Phase 1/Phase 2 study published in the October 2014 issue of Therapeutic Advances in Hematology found that men on prophylaxis treatment with Rixubis had a 75 percent lower annual bleeding rate than a group receiving on-demand treatment. There were no reports of serious adverse effects.
That approval for adults was followed by FDA approval of Rixubis for children in September 2014. It came in response to positive results from a clinical trial (NCT01488994) in 23 children with moderate to severe hemophilia B. All were than 12 years old and received Rixubis twice a week for six months. The treatment was shown to be safe and effective in this age group as well.
Sometimes a patient’s immune system responds to factor IX replacement therapy by forming antibodies against factor IX, called inhibitors, which keeps the product from working. Inhibitor or antibody formation was not a problem in trials of Rixubis, but patients should still be tested for inhibitors while on replacement therapy. Rixubis should also be used with caution in patients with a higher risk of developing blood clots, or thrombosis.
Rixubis comes in a powdered form that is combined with sterile water before use. It is given by injection, and may be used before surgery, as needed, or twice a week on a regular basis.
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