RIXUBIS Gets Results with Routine Prophylaxis

RIXUBIS—The first FDA-approved recombinant factor IX indicated for both routine prophylaxis treatment and bleed resolution in adults with hemophilia B1

Many patients taking RIXUBIS did not bleed over the course of 6 months

43%
of patients experienced zero bleeds during 6 months of RIXUBIS prophylactic treatment*1
  • The first FDA-approved recombinant factor IX indicated for routine prophylaxis to treat adults with hemophilia B

Know Your ABR

Annual bleed rate is the number of bleeds a person experiences over the course of one year. If you don't have a year's worth of bleeds tracked, simply take the number of bleeds that you had in the last month and multiply by 12 as an estimate, which is your annualized bleed rate (ABR).

*Prophylaxis efficacy of RIXUBIS was studied in 56 previously treated patients between 12 and 65 years of age with severe or moderately severe hemophilia B for a mean treatment duration of 6.2 ± 0.7 months.1

Selected 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.

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.

Some common side effects that have been reported with RIXUBIS include: unusual taste in the mouth, limb pain, and atypical blood test results.

RIXUBIS Achieved a Low ABR in Clinical Study Results When Used in Routine Prophylaxis Treatment1

The median ABR (range: 0-23.4) of the RIXUBIS group was also worth noting

Median ABR for spontaneous bleeds (range: 0-15.6) and joint bleeds (range: 0-21.5) with RIXUBIS

  • The majority of patients taking RIXUBIS had joint disease (88%) and target joints (66%) at screening

RIXUBIS delivered results by stopping most bleeds*

of bleeds were stopped with just 1 to 2 infusions of RIXUBIS

of bleeding episodes were rated by patients as having excellent or good bleed resolution with RIXUBIS

*The efficacy and safety of RIXUBIS were evaluated in a prospective, open-label, uncontrolled, multicenter study of 73 male previously treated patients between 12 and 65 years of age who received RIXUBIS either for routine prophylaxis or on-demand treatment.

Please see RIXUBIS Indications and Detailed Important Risk Information.

RIXUBIS Incremental Recovery for Previously Treated Patients

is the average incremental recovery level of RIXUBIS (IU/dL)

Know Your Recovery

After an infusion, your doctor may measure or keep track of the amount of factor IX in your blood. One such measure is called incremental recovery, or simply, recovery. Recovery is important to know because it helps your doctor determine the proper dose of factor your body needs.

Recovery is measured by taking a blood test, also called an assay. Recovery is different for every person and may change for you over time. It can be influenced by age and weight and differs based on the factor product used. 2, 9-11

Indications for RIXUBIS [Coagulation Factor IX (Recombinant)]

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

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

Some 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.

Baxalta, Baxject, and Rixubis are trademarks of Baxalta Incorporated, a wholly owned, indirect subsidiary of Shire plc. SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates..

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