References

  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. http://hemob.org/faq. 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. www.hemophilia.org. Accessed July 12, 2017.
  8. BAX 855 Previously Untreated Patient (PUP) [NCT02615691]. US National Institutes of Health website. www.clinicaltrials.gov. 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. www.clinicaltrials.gov. 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. www.clinicaltrials.gov. Accessed July 12, 2017.
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Important Risk Information for RIXUBIS [Coagulation Factor IX (Recombinant)]

Please read below for Indications and Detailed Important Risk Information for RIXUBIS. See full Prescribing Information.

Indications for RIXUBIS [Coagulation Factor IX (Recombinant)]

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).

RIXUBIS is used to control and prevent bleeding in people with hemophilia B. Your healthcare provider may give you RIXUBIS when you have surgery. RIXUBIS can reduce the number of bleeding episodes when used regularly (prophylaxis).

Detailed Important Risk Information for RIXUBIS [Coagulation Factor IX (Recombinant)]

You should not use RIXUBIS if you are allergic to hamsters or any ingredients in RIXUBIS.

You should tell your healthcare provider if you have or have had any medical problems, take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies, have any allergies, including allergies to hamsters, are nursing, are pregnant or planning to become pregnant, or have been told that you have inhibitors to factor IX.

Allergic reactions have been reported with RIXUBIS. Call your healthcare provider or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.

Your body may form inhibitors to factor IX. An inhibitor is part of the body's defense system. If you form inhibitors, it may stop RIXUBIS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for development of inhibitors to factor IX.

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.

Please see RIXUBIS full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.