Factor X (Human)
Class: Hemostatics
VA Class: BL500
Brands: Coagadex
Introduction
Preparation of blood coagulation factor X derived from pooled human plasma.
Uses for Factor X (Human)
Hereditary Factor X Deficiency
On-demand treatment and control of bleeding episodes in patients with hereditary factor X deficiency.
Perioperative management of bleeding in patients with mild hereditary factor X deficiency.
Designated an orphan drug by FDA for treatment of hereditary factor X deficiency.
Safety and efficacy for perioperative management of bleeding in patients with moderate or severe hereditary factor X deficiency undergoing major surgery†not established.
Hereditary factor X deficiency is a rare but serious bleeding disorder manifested by a lifelong bleeding tendency that typically includes umbilical bleeding during the neonatal period, easy bruising, mucosal bleeding, hemarthrosis, hematomas, intracranial hemorrhage, and GI bleeding. Women of reproductive age with factor X deficiency also may experience menorrhagia and postpartum hemorrhage.
Factor X (human) is a specific factor X concentrate and does not contain substantial amounts of other clotting proteins. Alternative treatment options such as other plasma-derived products (e.g., fresh frozen plasma, prothrombin complex concentrates [PCCs]) have disadvantages for factor X-deficient patients because in addition to factor X, they contain other plasma proteins that may contribute to adverse events.
Factor X (Human) Dosage and Administration
Administration
IV Administration
Administer by IV infusion.
May be self-administered if clinician determines that the patient and/or their caregiver is competent to safely administer the drug.
Do not mix with any other drugs or solutions.
Reconstitution
Prior to reconstitution, allow drug and manufacturer-supplied sterile water for injection diluent to warm to room temperature.
Reconstitute single-use vials of lyophilized drug by adding 2.5 or 5 mL of sterile water for injection to vial containing approximately 250 or 500 units, respectively, of factor X (human) using transfer device provided by manufacturer; resulting solution contains approximately 100 units of factor X (human) activity per mL. Swirl vial gently until powder is completely dissolved.
If more than 1 vial is required to obtain a dose, may pool reconstituted contents of multiple vials; use a separate transfer set to reconstitute each vial.
Administer reconstituted solutions promptly or within 1 hour.
Rate of Administration
10 mL/minute; do not exceed 20 mL/minute.
Dosage
Dosage expressed in international units (IU, units) of factor X activity. Each vial contains approximately 250 or 500 units of factor X (human); actual number of units indicated on each vial and carton. Generally, 1 unit/kg of factor X (human) increases plasma factor X levels by 2 units/dL.
Dose and duration of therapy dependent upon severity of the factor X deficiency, the location and extent of ...
