Generic Name and Formulations:
Coagulation Factor IX (recombinant), Fc Fusion Protein 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU, 4000 IU; per vial; lyophilized pwd for IV inj after reconstitution; preservative-free; contains sucrose, mannitol, sodium chloride, L-histidine, polysorbate 20.
Indications for ALPROLIX:
Hemophilia B, for the on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Limitations Of use:
Not for induction of immune tolerance in Hemophilia B patients.
Adults and Children:
Dose (IU) = body weight (kg) x desired FIX increase (% of normal or IU/dL) x reciprocal of recovery (IU/kg per IU/dL). More frequent or higher doses may be needed in children <12yrs (esp. <6yrs). Individualize. Give by IV bolus infusion only. Max infusion rate 10mL/min. Treatment/control of bleeding: Minor/Moderate: 30–60% required; repeat every 48hrs if needed. Major: 80–100% required; consider a repeat dose after 6–10hrs, then every 24hrs for the first 3 days; then may reduce dose and frequency to every 48hrs or longer until bleeding stops and healing is achieved. Peri-op: Minor: 50–80% required as a single infusion; repeat as needed after 24–48hrs until bleeding stops and healing is achieved. Major: initially 60–100% required; consider a repeat dose after 6–10hrs, then every 24hrs for the first 3 days; then may reduce dose and frequency to every 48hrs or longer until bleeding stops and healing is achieved. Routine prophylaxis (<12yrs): initially 60 IU/kg once weekly; (≥12yrs): initially 50 IU/kg once weekly or 100 IU/kg once every 10 days.
Discontinue and treat if hypersensitivity symptoms occur. Evaluate 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 recommended dose. Potential risk for thromboembolic complications; monitor. Pregnancy. Nursing mothers.
Headache, oral paresthesia, obstructive uropathy; hypersensitivity reactions.
Kit—1 (single-use vial + diluent, supplies)