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 Factor X deficiency: for on-demand treatment and control of bleeding episodes and for perioperative management in mild hereditary Factor X deficiency.
Limitations Of use:
Not studied in perioperative management in major surgery for patients with moderate and severe hereditary Factor X deficiency.
Dosage Required (IU) = Body Weight (kg) × Desired Factor X Increase (IU/dL) × 0.5 (IU/kg per IU/dL). Give by IV infusion at a rate of 10mL/min; max 20mL/min. Bleeding: 25 IU/kg at first sign of bleeding; repeat every 24hrs until the bleed stops. Perioperative: Pre-op: raise plasma FX levels to 70–90 IU/dL; Post-op: repeat dose as needed to maintain FX levels at minimum of 50 IU/dL until patient is no longer at bleeding risk. All: max 60 IU/kg daily. Adjust based on response.
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; anaphylaxis, possible antibody formation.
Single-dose vial—1 (w. diluent, supplies)