Dosing and Administration

To fit your patients' lifestyle, RIXUBIS® is indicated for prophylaxis, on-demand and perioperative dosing. See below for specific dosing information and a demonstration video with instructions for the BAXJECT II® Needle-less transfer device.

Initial dose for control of bleeding episodes and perioperative management1

Patients ≥12 years of age

An empirical estimate for incremental recovery of 0.9 IU/dL of plasma (0.9% of normal) is used to calculate the initial dose of RIXUBIS with the following formula:

Initial dose calculation for patients 12 years and older. Body weight (kg) times desired factor IX increase (% of normal of IU/dL) times 1.1 dL/kg. Initial dose calculation for patients 12 years and older. Body weight (kg) times desired factor IX increase (% of normal of IU/dL) times 1.1 dL/kg.

Patients <12 years of age

An empirical estimate for incremental recovery of 0.7 IU/dL of plasma (0.7% of normal) is used to calculate the initial dose of RIXUBIS with the following formula:

Initial dose calculation for patients under 12 years of age. Body weight (kg) times desired factor IX increase (% of normal of IU/dL) times 1.4 dL/kg. Initial dose calculation for patients under 12 years of age. Body weight (kg) times desired factor IX increase (% of normal of IU/dL) times 1.4 dL/kg.

Dosage and duration of treatment with RIXUBIS depend on the severity of factor IX deficiency, the location and extent of bleeding, the patient’s clinical condition, age, and pharmacokinetic parameters of factor IX, such as incremental recovery and half-life.

Please see RIXUBIS full Prescribing Information for complete dosing guidelines and example calculations.

Twice-weekly dosing for prophylactic treatment1

  Dose Dosing Frequency
PTPs ≥12 years of age 40‑60 IU/kg Twice‑weekly
PTPs <12 years of age 60‑80 IU/kg Twice‑weekly

Adjust the dose based on the individual patient’s age, bleeding pattern, and physical activity.

Dosing for control and prevention of bleeding episodes1

Type of Bleeding Episodes

MINOR
Uncomplicated hemarthrosis, superficial muscular or soft tissue

Circulating Factor IX Level Required (% or IU/dl)

20‑30

Dosing Interval (hours)

12‑24

Duration of Therapy (days)

At least 1 day, until healing is achieved
MODERATE
Intramuscular or soft tissue with dissection, mucous membranes, hematuria

Circulating Factor IX Level Required (% or IU/dl)

25‑50

Dosing Interval (hours)

12‑24

Duration of Therapy (days)

2-7 days, until bleeding stops and healing is achieved
MAJOR
Pharyngeal, retropharyngeal, retroperitoneal, CNS

Circulating Factor IX Level Required (% or IU/dl)

50‑100

Dosing Interval (hours)

12‑24

Duration of Therapy (days)

7-10 days, until bleeding stops and healing is achieved

Ensure the factor IX activity level is achieved and maintained in the corresponding period.

Dosing for perioperative management1

Type of Surgery

MINOR
e.g., tooth extraction

Circulating Factor IX Level Required (% or IU/dl)

30‑60

Dosing Interval (hours)

24

Duration of Therapy (days)

At least 1 day, until healing is achieved
MAJOR
e.g., intracranial, intraabdominal, intrathoracic, joint replacement

Circulating Factor IX Level Required (% or IU/dl)

80‑100

Dosing Interval (hours)

8‑24

Duration of Therapy (days)

7-10 days, until bleeding stops and healing is achieved

Ensure the factor IX activity level is achieved and maintained in the corresponding period.

Infusion information: The maximum infusion rate is 10 mL/min.1

BAXJECT II® demonstration video

Watch the video for step-by-step instructions for the BAXJECT II Needle-less Transfer device.

For step-by-step instructions on reconstituting RIXUBIS with the BAXJECT II Needle-less Transfer device, download the step-by-step guide.

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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® [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.