RIXUBIS Rx

Indications for RIXUBIS:

Control and prevention of bleeding episodes, perioperative management, and routine prophylaxis in hemophilia B.

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.

Contraindications:

Hamster protein hypersensitivity. Disseminated intravascular coagulation (DIC). Signs of fibrinolysis.

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.

Pharmacological Class:

Clotting factor.

Adverse Reactions:

Dysgeusia, extremity pain, positive test for furin antibody; hypersensitivity reactions (discontinue if occur).

How Supplied:

Single-use vials—1 (w. diluent, supplies)