New Factor IX Product: RIXUBIS Available in October
Horizons in Hemophilia, October 2013
By Leigh Carpenter, RPh, Director of Pharmacy
Baxter has announced RIXUBIS, the first new recombinant factor IX approved for hemophilia B in more than 15 years, has been approved by the FDA. It is the only recombinant factor IX indicated for both routine prophylaxis and on-demand control of bleeding episodes for patients 16 years of age and older. The medication will be available in 5 different international unit dosage ranges: 250, 500, 1000, 2000 and 3000 (the 2000 IU range will not be available until November). Each vial will be packaged with a Baxject II needleless transfer mixing device. The diluent volume of each will be 5ml.
Baxter’s press release states “approval was based on a Phase 1/III study showing twice-weekly prophylactic infusions with RIXUBIS for six months achieved a median annualized bleed rate (ABR) of 2.0 with 43 percent of patients experiencing no bleeds.” Dosing is based on 40 to 60 IU per kg.
You may store RIXUBIS at a refrigerated temperature between 35 to 46 degrees F. for up to 18 months. RIXUBIS may also be stored at room temperature not to exceed 86 degrees F. for up to 6 months within the 18-month time period. If choosing to store at room temperature, write the date it was removed from refrigeration on the carton of the box. After storage at room temperature, do not return the product to the refrigerator.
RIXUBIS contains trace amounts of Chinese hamster ovary (CHO) proteins. The most common adverse reactions observed in >1% of patients in clinical studies were alterations in sense of taste and pain in extremity.
If you are interested in obtaining a prescription for RIXUBIS, please contact your Hemophilia Treatment Center staff. The Hemophilia of Georgia and Beacon pharmacies will be able to order this new product in October.