Generic Name and Formulations:
Coagulation Factor X (human) 250 IU, 500 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Indications for COAGADEX:
In patients with hereditary Factor X deficiency: on-demand treatment and control of bleeding episodes, perioperative management in mild and moderate Factor X deficiency, and routine prophylaxis to reduce frequency of bleeding episodes.
Limitations Of use:
Not studied in perioperative management in major surgery for patients with severe hereditary Factor X deficiency.
Adults and Children:
See full labeling. Give by IV infusion at a rate of 10mL/min; max 20mL/min. Bleeding (<12yrs): initially 30 IU/kg; (≥12yrs): initially 25 IU/kg. Give at first sign of bleeding; repeat every 24hrs until resolved. Perioperative (<12yrs): Dosage Required (IU) = Body Weight (kg) × Desired Factor X Increase (IU/dL or % of normal) × 0.6; (≥12yrs): Dosage Required (IU) = Body Weight (kg) × Desired Factor X Increase (IU/dL or % of normal) × 0.5. Pre-op: calculate dose to raise plasma FX levels to 70–90 IU/dL; Post-op: repeat dose as needed to maintain plasma FX levels at minimum of 50 IU/dL until patient is no longer at bleeding risk. Routine prophylaxis (<12yrs): initially 40 IU/kg twice weekly; (≥12yrs): initially 25 IU/kg twice weekly. Monitor FX levels; adjust to clinical response and FX trough levels of ≥5 IU/dL (max peak 120 IU/dL). All: max 60 IU/kg daily.
Monitor for development of Factor X inhibitors. Immediately discontinue if hypersensitivity reactions occur. Contains human plasma; monitor for possible infection transmission (eg, viruses, Creutzfeldt-Jakob disease agent). Pregnancy. Nursing mothers.
Caution with concomitant other Factor X-containing plasma products (eg, fresh frozen plasma, prothrombin complex concentrates).
Infusion site erythema/pain, fatigue, back pain; possible antibody formation.
Single-dose vial—1 (w. diluent, supplies)
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