Rixubis

— THERAPEUTIC CATEGORIES —
  • Bleeding disorders

Rixubis Generic Name & Formulations

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)

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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