About RIXUBISRIXUBIS [Coagulation Factor IX (Recombinant)] is a recombinant factor IX (rFIX) protein for both routine prophylaxis and control of bleeding episodes in adults with hemophilia B. RIXUBIS is the first new rFIX approved to treat hemophilia B in more than 15 years and is the first rFIX approved by the FDA for both routine prophylaxis and control of bleeding episodes in this chronic condition. Indications for RIXUBIS RIXUBIS [Coagulation Factor IX (Recombinant)] is an antihemophilic factor indicated for:
- Control and prevention of bleeding episodes in adults with hemophilia B.
- Perioperative management in adults with hemophilia B.
- Routine prophylaxis to prevent or prevent or reduce the frequency of bleeding episodes in adults with hemophilia B.
- Known hypersensitivity to RIXUBIS or its excipients including hamster protein
- Disseminated intravascular coagulation (DIC)
- Signs of fibrinolysis
Nephrotic syndrome has been reported following attempted immune tolerance induction in hemophilia B patients with factor IX inhibitors. The safety and efficacy of using RIXUBIS for immune tolerance induction have not been established.The use of factor IX containing products has been associated with the development of thromboembolic complications. The most common adverse reactions observed in >1% of subjects in clinical studies were: dysgeusia, pain in extremity, and positive test for furin antibody. The following class adverse reactions have been seen with another recombinant factor IX: inadequate factor IX recovery, inhibitor development, anaphylaxis, angioedema, dyspnea, hypotension, and thrombosis. Please see the RIXUBIS full Prescribing Information at: www.baxter.com/downloads/healthcare_professionals/products/RIXUBIS_PI.pdf . About Hemophilia B Hemophilia B is the second most common type of hemophilia (also known as Christmas disease) and is the result of insufficient amounts of clotting factor IX, a naturally occurring protein in blood that controls bleeding. 1 Approximately 26,000 people worldwide, including more than 4,000 in the U.S., have been diagnosed with hemophilia B. 1 Hemophilia B is often a debilitating, chronic disease with complications that include bleeding episodes, hemophilic arthropathy (bleeding into a joint) and hospitalization. 2 About Baxter in Hemophilia Baxter has more than 60 years of experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. The company has the broadest portfolio of hemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company’s work is focused on optimizing hemophilia care and improving the lives of people living with hemophilia A and B worldwide. Its diverse pipeline includes longer-acting therapies for hemophilia A, potential new treatments for hemophilia B (including gene therapy), von Willebrand disease and a recombinant treatment for patients with inhibitors.
About Baxter International Inc.Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. 1 2011 Annual Global Survey. World Federation of Hemophilia. Accessed on October 16, 2013. Available at: http://www1.wfh.org/publications/files/pdf-1488.pdf 2 Rodríguez-Merchán E-C, Valentino LA. New developments in hemophilic arthropathy. In: Rodríguez-Merchán E-C, Valentino LA, eds., Current and Future Issues in Hemophilia Care, Oxford, UK: Wiley-Blackwell; 2011, Ch. 29. doi: 10.1002/9781119979401.