RIXUBIS® Safety Profile from the Clinical Trials
During clinical development in a combined study, 99 male PTPs received a total of 14,018 infusions of RIXUBIS and were treated with RIXUBIS for a median of 156 exposure days (range: 8 to 316 days), with a median number of 163 infusions (range: 8 to 327 infusions).1
*Low-titer, non-neutralizing antibodies against factor IX were observed in 21 (21.2%) subjects at one or more time points. No clinical adverse findings were observed in any of these 21 subjects.1
Selected Important Risk Information for RIXUBIS [Coagulation Factor IX (Recombinant)]
If you have risk factors for developing blood clots, the use of factor IX products may increase the risk of abnormal blood clots.
Common side effects that have been reported with RIXUBIS include: unusual taste in the mouth, limb pain, and atypical blood test results.
Call your healthcare provider right away about any side effects that bother you or if your bleeding does not stop after taking RIXUBIS.
RIXUBIS® is manufactured using a validated 2-step virus inactivation and removal process1
Developed by Shire
Shire has over 60 years of dedicated history to the hematology and rare disorders communities.
RIXUBIS is a third-generation recombinant factor IX, produced by DNA technology. No human or animal proteins are added during any stage of manufacturing or formulation of RIXUBIS.1,6,7