Notice Regarding BAXJECT II Reconstitution Devices Packaged with RIXUBIS.

Multiple strengths to fit your patients' needs

RIXUBIS offers a variety of vial sizes and a maximum infusion rate of 10 mL/min.

Wide range of dosage options1

  • 5 dosage strengths provide the opportunity for single-vial dosing
  • Each dose is color-coded
  • Each kit contains 5 mL of Sterile Water for Injection and a BAXJECT® II transfer device
3 ways to use RIXUBIS: Prophylaxis, On Demand and Perioperative.

Initial dose for control and prevention 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:

Dosing calculation for patients 12 and older is done by multiplying the body weight (kg) x desired factor IX increase x 1.1 dL/kg. Dosing calculation for patients 12 and older is done by multiplying the body weight (kg) x desired factor IX increase x 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:

Dosing calculation for patients under 12 is done by multiplying the body weight (kg) x desired factor IX increase x 1.4 dL/kg. Dosing calculation for patients under 12 is done by multiplying the body weight (kg) x desired factor IX increase x 1.4 dL/kg.

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

Twice-weekly dosing for routine 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
RIXUBIS dose and dosing frequency table for PTPs.

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

Dosing for on-demand treatment and control 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
RIXUBIS dosing table for minor, moderate, and major types of bleeding episodes.

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
RIXUBIS dosing table for minor and major types of surgery.

Mixing is facilitated by the BAXJECT® II Needle-less Transfer device1

The BAXJECT II is needle-less and has a one-piece design.1

BAXJECT II® instructions. Step 1: Connect water vial. Step 2: Connect product vial. Step 3: Swirl gently until powder is completely dissolved. The maximum infusion rate is 10 mL/minute.

For step-by-step instructions on reconstituting RIXUBIS with the BAXJECT II Needle-less Transfer device, watch the step-by-step video. You may also download and read these instructions if your patients are ready to start reconstituting or experience difficulty with the BAXJECT II device.

How to store RIXUBIS®1

Store at refrigerated temperature [2°C to 8°C (36°F to 46°F)] or store at room temperature [not to exceed 30°C (86°F)] for up to 36 months. Do not freeze.

Do not use beyond the expiration date printed on the carton or vial.

Indications

RIXUBIS® [Coagulation Factor IX (Recombinant)] is an antihemophilic factor indicated in adults and children with hemophilia B for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding
  • Routine prophylaxis to reduce the frequency of bleeding episodes...

RIXUBIS® [Coagulation Factor IX (Recombinant)] is an antihemophilic factor indicated in adults and children with hemophilia B for...

Selected Important Risk Information

CONTRAINDICATIONS

RIXUBIS is contraindicated in patients who have:

RIXUBIS is contraindicated in patients who have...

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