RIXUBIS [Coagulation Factor IX (Recombinant)] resources for healthcare professionals

RIXUBIS® [Coagulation Factor IX (Recombinant)] for the Treatment of Children and Adults with Hemophilia B

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Resources for Your Patients

Please see RIXUBIS Indications and Detailed Important Risk Information.

Efficacy with RIXUBIS Routine Prophylactic Treatment

Patients ≥12 years of age

Many patients ≥12 years of age experienced zero bleeds during a mean treatment duration of 6.2 months on RIXUBIS® prophylactic treatment1,2

In the clinical study, the prophylactic efficacy of RIXUBIS was studied in 56 previously treated patients (PTPs) 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.1,2

43%
of patients experienced zero bleeds on RIXUBIS prophylaxis1,2
  • A recombinant factor IX indicated for routine prophylaxis to treat children and adults with hemophilia B1

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.

Post-marketing Experience

The following class of adverse reactions have been seen with another recombinant factor IX: inadequate factor IX recovery, inhibitor development, anaphylaxis, angioedema, hypotension, and thrombosis.

Please see RIXUBIS Indications and Detailed Important Risk Information.


RIXUBIS achieved a low Annual Bleed Rate (ABR) in clinical study results when used in routine prophylactic treatment in patients ≥12 years of age1

RIXUBIS delivered results by treating most bleeds in patients ≥12 years of age1

The efficacy of RIXUBIS was evaluated in a prospective, open-label, uncontrolled, multicenter study of 73 male PTPs between 12 and 65 years of age who received RIXUBIS either for routine prophylaxis or on-demand treatment.1

85 of bleeds
were treated with just 1 to 2 infusions of RIXUBIS
96 of bleeding episodes
were rated by patients as having excellent or good bleed resolution with RIXUBIS

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.1

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

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (including symptoms such as dyspnea and pruritus) have been reported with RIXUBIS. Anaphylaxis and other hypersensitivity reactions are possible. Early signs of allergic reactions, which can progress to anaphylaxis, include angioedema, chest tightness, hypotension, lethargy, nausea, vomiting, paresthesia, urticaria, rash, restlessness, wheezing, and dyspnea. Immediately discontinue administration and initiate appropriate treatment if allergic- or anaphylactic-type reactions occur.

Inhibitors

Development of neutralizing antibodies (inhibitors) to factor IX 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.

Please see RIXUBIS Indications and Detailed Important Risk Information.

RIXUBIS incremental recovery in previously treated patients ≥12 years of age1

0.9IU/dL
is the average incremental
recovery level of RIXUBIS

Mean incremental recovery for RIXUBIS 30 minutes after infusion at trial completion/termination.

Patients <12 years of age

Many patients <12 years of age experienced zero bleeds during a mean treatment duration of 7.7 months on RIXUBIS® prophylactic treatment1,3

In the pediatric study, the prophylactic efficacy of RIXUBIS was studied in 23 PTPs between 1.8 and 11.8 years with severe or moderately severe hemophilia B for a mean treatment duration of 7.7 ± 1.08 months.1,3

39%
of patients experienced zero bleeds on RIXUBIS prophylaxis1,3
  • A recombinant factor IX indicated for routine prophylaxis to treat children and adults with hemophilia B1

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.

Post-marketing Experience

The following class of adverse reactions have been seen with another recombinant factor IX: inadequate factor IX recovery, inhibitor development, anaphylaxis, angioedema, hypotension, and thrombosis.

Please see RIXUBIS Indications and Detailed Important Risk Information.


RIXUBIS achieved a low Annual Bleed Rate (ABR) in clinical study results when used in routine prophylactic treatment in patients <12 years of age1

RIXUBIS delivered results by treating most bleeds in children <12 years of age1

The efficacy of RIXUBIS was evaluated in a pediatric study, in which a total of 23 male PTPs between 1.8 and 11.8 years of age (mean age 7.10 years), with 11 subjects <6 years of age, received RIXUBIS for routine prophylaxis and control of bleeding episodes.1

89 of bleeds
were treated with just 1 to 2 infusions of RIXUBIS
96 of bleeding episodes
were rated by patients as having excellent or good bleed resolution with RIXUBIS

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.1

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

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions (including symptoms such as dyspnea and pruritus) have been reported with RIXUBIS. Anaphylaxis and other hypersensitivity reactions are possible. Early signs of allergic reactions, which can progress to anaphylaxis, include angioedema, chest tightness, hypotension, lethargy, nausea, vomiting, paresthesia, urticaria, rash, restlessness, wheezing, and dyspnea. Immediately discontinue administration and initiate appropriate treatment if allergic- or anaphylactic-type reactions occur.

Inhibitors

Development of neutralizing antibodies (inhibitors) to factor IX 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.

Please see RIXUBIS Indications and Detailed Important Risk Information.

RIXUBIS incremental recovery in previously treated patients <12 years of age1

0.7IU/dL
is the average incremental
recovery level of RIXUBIS

Mean incremental recovery for RIXUBIS 30 minutes after infusion at trial completion/termination.

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