Rixubis Generic Name & Formulations
Legal Class
Rx
General Description
Coagulation Factor IX (recombinant) 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Pharmacological Class
Clotting factor.
How Supplied
Single-use vials—1 (w. diluent, supplies)
Manufacturer
Generic Availability
NO
Rixubis Indications
Indications
Control and prevention of bleeding episodes, perioperative management, and routine prophylaxis in hemophilia B.
Rixubis Dosage and Administration
Adult
Empirical finding: 1 IU/kg increases circulating activity of FIX by 0.9 IU/dL. Initial dose = body weight (kg) x desired FIX increase (% or IU/dL) x reciprocal of observed recovery (IU/dL per IU/kg). Incremental recovery in previously treated patients (PTPs): Dose (IU) = body weight (kg) x desired FIX increase (% or IU/dL) x 1.1 dL/kg. Individualize. Give by IV bolus infusion only. Max infusion rate 10mL/min. Control/prevention of bleeding: Minor: 20–30% required every 12–24hrs for at least 1 day until healing achieved. Moderate: 25–50% required every 12–24hrs for 2–7 days until bleeding stops and healing achieved. Major: 50–100% required every 12–24hrs for 7–10 days until bleeding stops and healing achieved. Peri-op management: Minor surgery: 30–60% required every 24hrs for at least 1 day until healing achieved. Major surgery: 80–100% required every 8–24hrs for 7–10 days until bleeding stops and healing achieved. Routine prophylaxis in PTPs: 40–60 IU/kg twice weekly; titration may be necessary based on patient's age, bleeding pattern, physical activity.
Children
Empirical finding: 1 IU/kg increases circulating activity of FIX by 0.7 IU/dL. Initial dose = body weight (kg) x desired FIX increase (% or IU/dL) x reciprocal of observed recovery (IU/dL per IU/kg). Incremental recovery in previously treated patients (PTPs): Dose (IU) = body weight (kg) x desired FIX increase (% or IU/dL) x 1.4 dL/kg. Individualize. Give by IV bolus infusion only. Max infusion rate 10mL/min. Control/prevention of bleeding: Minor: 20–30% required every 12–24hrs for at least 1 day until healing achieved. Moderate: 25–50% required every 12–24hrs for 2–7 days until bleeding stops and healing achieved. Major: 50–100% required every 12–24hrs for 7–10 days until bleeding stops and healing achieved. Peri-op management: Minor surgery: 30–60% required every 24hrs for at least 1 day until healing achieved. Major surgery: 80–100% required every 8–24hrs for 7–10 days until bleeding stops and healing achieved. Routine prophylaxis in PTPs: 60–80 IU/kg twice weekly; titration may be necessary based on patient's age, bleeding pattern, physical activity.
Rixubis Contraindications
Contraindications
Hamster protein hypersensitivity. Disseminated intravascular coagulation (DIC). Signs of fibrinolysis.
Rixubis Boxed Warnings
Not Applicable
Rixubis Warnings/Precautions
Warnings/Precautions
Not for induction of immune tolerance in patients with hemophilia B; risk of nephrotic syndrome. Monitor regularly for development of Factor IX inhibitors; measure Factor IX inhibitor concentration if expected activity plasma levels are not attained, or if bleeding is not controlled with an expected dose. Potential risk for thromboembolic complications; monitor for signs of thrombotic and consumptive coagulopathy in patients with liver disease, signs of fibrinolysis, peri- and post-operatively, or at risk for thrombotic events or DIC. Pregnancy (Cat.C). Nursing mothers.
Rixubis Pharmacokinetics
See Literature
Rixubis Interactions
Not Applicable
Rixubis Adverse Reactions
Adverse Reactions
Dysgeusia, extremity pain, positive test for furin antibody; hypersensitivity reactions (discontinue if occur).
Rixubis Clinical Trials
See Literature
Rixubis Note
Not Applicable
Rixubis Patient Counseling
See Literature
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