Consider routine prophylactic treatment for your active patients

2X weekly dosing can help align factor levels with times of high physical activity1

2 infusion days per week
2 infusion days per week

Efficacy

Study design ≥12 years of age

The efficacy and safety of RIXUBIS® were evaluated in a prospective, open-label, uncontrolled, multicenter study of 73 male previously treated patients (PTPs) with severe or moderately severe hemophilia B who received RIXUBIS either for routine prophylaxis (mean duration 6 months) or on-demand treatment.1,6

Study design <12 years of age

In the pediatric study, the efficacy and safety of RIXUBIS were evaluated in 23 male previously treated patients (PTPs) with severe or moderately severe hemophilia B. Patients between 1.8 and 11.8 years of age (median age 7.10 years), with 11 subjects <6 years of age, received RIXUBIS for routine prophylaxis and control of bleeding episodes for a mean treatment duration of 7.7 months.1,2

Clinical trials demonstrated that recovery levels were consistent over time in all patient groups1

12 years and older: 0.9 IU/dL average incremental recovery level (n=55)
Under 12 years of age: 0.7 IU/dL average incremental recovery level (n=21)

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

CONTRAINDICATIONS

RIXUBIS is contraindicated in patients who have:

  • Known hypersensitivity to RIXUBIS or its excipients including hamster protein
  • Disseminated Intravascular Coagulation (DIC)
  • Signs of fibrinolysis

ADVERSE REACTIONS

Common adverse reactions observed in >1% of subjects in clinical studies were: dysgeusia, pain in extremity, and positive test for furin antibody.

Routine prophylactic treatment helped patients achieve a low annualized bleed rate (ABR)*1

Median ABR in patients ≥12 years of age (n=56)1,6 Patients 12 years and older
Spontaneous Bleeds

Median ABR (range: 0.0-15.6)

Joint Bleeds

Median ABR (range: 0.0-21.5)

Median ABR in patients <12 years of age (N=23)1,2 Patients under 12 years of age
Spontaneous Bleeds

Median ABR (range: 0.0-2.0)

Joint Bleeds

Median ABR (range: 0.0-7.2)

Median ABR in both age groups1
Total Bleeds

(range: 0.0-23.4 for PTPs ≥12 years of age and 0-10.8 for PTPs <12 years of age)

*The majority of patients ≥12 years taking RIXUBIS had joint disease (88%) and target joints (66%) at screening.1

Effectively resolved most bleeds with 1 to 2 infusions1

In patients 12 years and older, 85% of bleeds stopped with 1 to 2 infusions.
In patients under 12 years of age, 89% of bleeds stopped with 1 to 2 infusions.

With RIXUBIS, 96% of bleeding episodes were rated as having excellent or good bleed resolution in both children and adults.*1

*Excellent is defined as full relief of pain and cessation of objective signs of bleeding after a single infusion; no additional infusion is required for the control of bleeding; good is defined as definite pain relief and/or improvement in signs of bleeding after a single infusion; possibly requires more than one infusion for complete resolution.

RIXUBIS safety profile

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

In clinical trials, after 14,018 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)]

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, may occur. Should symptoms occur, discontinue RIXUBIS and administer appropriate treatment. Patients may also develop hypersensitivity to hamster (CHO) protein, which is present in trace amounts in the product.

Inhibitors

Development of neutralizing antibodies (inhibitors) to RIXUBIS may occur. Regularly evaluate patients for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected factor IX plasma activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor IX inhibitor concentration. Patients with factor IX inhibitors are at an increased risk of severe hypersensitivity reactions or anaphylaxis if re-exposed to RIXUBIS.

+

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® [Coagulation Factor IX (Recombinant)] is an antihemophilic factor indicated in adults and children with hemophilia B for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis.

RIXUBIS is not indicated for induction of immune tolerance in patients with hemophilia B.

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

CONTRAINDICATIONS

RIXUBIS is contraindicated in patients who have:

  • Known hypersensitivity to RIXUBIS or its excipients including hamster protein
  • Disseminated Intravascular Coagulation (DIC)
  • Signs of fibrinolysis

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, may occur. Should symptoms occur, discontinue RIXUBIS and administer appropriate treatment. Patients may also develop hypersensitivity to hamster (CHO) protein, which is present in trace amounts in the product.

Inhibitors
Development of neutralizing antibodies (inhibitors) to RIXUBIS may occur. Regularly evaluate patients for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected factor IX plasma activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor IX inhibitor concentration. Patients with factor IX inhibitors are at an increased risk of severe hypersensitivity reactions or anaphylaxis if re-exposed to RIXUBIS.

Nephrotic Syndrome
Nephrotic syndrome has been reported following attempted immune tolerance induction with factor IX products in hemophilia B patients that have factor IX inhibitors. The safety and efficacy of using RIXUBIS for immune tolerance induction have not been established.

Thromboembolic Complications
The use of factor IX containing products has been associated with the development of thromboembolic complications. Monitor patients for early signs of thromboembolic and consumptive coagulopathy, when administering RIXUBIS to patients with liver disease, with signs of fibrinolysis, peri- and post-operatively, or at risk for thromboembolic events or DIC.

ADVERSE REACTIONS
Common adverse reactions observed in >1% of subjects in clinical studies were: dysgeusia, pain in extremity, and positive test for furin antibody.

Please see RIXUBIS full Prescribing Information.