Alprolix Generic Name & 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.
Kit—1 (single-use vial + diluent, supplies)
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.
Alprolix Dosage and Administration
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.
Alprolix Boxed Warnings
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.
Alprolix Adverse Reactions
Headache, oral paresthesia, obstructive uropathy; hypersensitivity reactions.
Alprolix Clinical Trials
Alprolix Patient Counseling