Notice Regarding BAXJECT II Reconstitution Devices Packaged with RIXUBIS.


  1. RIXUBIS [Prescribing Information].
  2. Urasinski T, Stasyshyn O, Andreeva T, et al. Recombinant factor IX (BAX326) in previously treated paediatric patients with haemophilia B: a prospective clinical trial. Haemophilia. 2015;21(2):196-203.
  3. FAQs about Hemophilia B. The Coalition for Hemophilia B website. Accessed July 12, 2017.
  4. Ewenstein BM, Joist JH, Shapiro AD, et al. Pharmacokinetic analysis of plasma-derived and recombinant F IX concentrates in previously treated patients with moderate or severe hemophilia B. Transfusion. 2002:42(2):190-197.
  5. White GC 2nd, Shapiro AD, Kurczynski EM, Kim HC, Bergman GE, the Mononine Study Group. Variability of in vivo recovery of factor IX after infusion of monoclonal antibody purified factor IX concentrates in patients with hemophilia B. Thromb Haemost. 1995;73(5):779-784.
  6. Windyga J, Lissitchkov T, Stasyshyn O, et al. Pharmacokinetics, efficacy and safety of BAX326, a novel recombinant factor IX: a prospective, controlled, multicentre phase I/III study in previously treated patients with severe (FIX level <1%) or moderately severe (FIX level ≤2%) haemophilia B. Haemophilia. 2014;20(1):15-24.
  7. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. National Hemophilia Foundation. Accessed October 3, 2018.
  8. BAX 855 Previously Untreated Patient (PUP) [NCT02615691]. US National Institutes of Health website. Accessed August 24, 2017.
  9. Open-Label Single Ascending Dose of Adeno-associated Virus Serotype 8 Factor IX Gene Therapy in Adults With Hemophilia B [NCT01687608]. US National Institutes of Health website. Accessed July 12, 2017.
  10. Genotype and Phenotype Correlation in Hereditary Thrombotic Thrombocytopenic Purpura (Upshaw-Schulman Syndrome) (TTP registry) [NCT01257269]. US National Institutes of Health website. Accessed July 12, 2017.
  11. Shire's 70+ Year Commitment to the Hemophilia Community. Takeda website. Published January 2018. Accessed June 24, 2020.

What is RIXUBIS?

RIXUBIS is an injectable medicine used to replace clotting factor IX that is missing in adults and children with hemophilia B (also called congenital factor IX deficiency or Christmas disease)...

Selected Important Risk Information

Who should not use RIXUBIS?

You should not use RIXUBIS if you are allergic to hamsters or any ingredients in RIXUBIS. Tell your healthcare provider if you are pregnant or breastfeeding because RIXUBIS may not be right for you.
You should tell your healthcare provider if you have or have had any medical...