Coagadex (coagulation factor X)

Factor X (human) is a preparation of blood coagulation factor X derived from pooled human plasma.

Factor X (human) is a sterile, purified, lyophilized concentrate of factor X derived from pooled human plasma. All plasma used in the manufacture of factor X (human) is obtained from healthy US donors and is screened for hepatitis B surface antigen and antibodies to human immunodeficiency virus-1 (HIV-1), HIV-2, and hepatitis C virus (HCV). Donor plasma also is tested using a nucleic acid assay for HCV, HIV-1, hepatitis A virus (HAV), hepatitis B virus (HBV) and parvovirus B19.

Factor X (human) is isolated from human plasma and purified using a series of viral inactivation/removal steps, including solvent/detergent treatment, nanofiltration, and terminal dry heat treatment. Reconstituted factor X (human) contains not more than 1 unit/mL of factor II and factor IX. In addition, factor X (human) contains no added biological components such as heparin, albumin, or antithrombin.

Factor X (Stuart-Prower factor) is a vitamin K-dependent plasma proenzyme that plays a central role in the blood coagulation cascade as the first enzyme in the common pathway of thrombus formation. Factor X is synthesized in the liver and circulates in plasma as a 2-chain glycoprotein. The primary structure of human factor X is highly homologous to other vitamin K-dependent clotting factors such as factor VII, factor IX, and protein C and shares similar structure-function relationships.

Factor X can be activated by factor IXa (via the intrinsic pathway) or by factor VIIa (via the extrinsic pathway). Factor X is converted from its inactive form to the active form (factor Xa) by cleavage of a 52-residue peptide from the heavy chain. Factor Xa associates with factor Va on a phospholipid surface to form the prothrombinase complex, which activates prothrombin to thrombin in the presence of calcium ions.

Thrombin then acts upon soluble fibrinogen and factor XIII to generate a cross-linked fibrin clot.

The administration of factor X (human) increases plasma levels of factor X and can temporarily correct the coagulation defect in patients with hereditary factor X deficiency. In a pharmacokinetic, efficacy, and safety trial in 16 patients 12-58 years of age with moderate or severe hereditary factor X deficiency, plasma factor X activity level rapidly increased after initial IV administration of factor X (human) 25 units/kg, reaching a peak at 0.5 hours.

Factor X (human) is cleared slowly from plasma with a half-life of approximately 30 hours. Repeat dosing of factor X (human) does not lead to accumulation in the systemic circulation as there was virtually no difference in the pharmacokinetic profiles for factor X (human) at baseline and at least 6 months later in patients receiving an on-demand treatment regimen (25 units/kg per dose) with the drug for hereditary factor X deficiency.

USES: This medication is used to prevent or control bleeding in people with little or no factor X, a condition also known as Stuart-Prower deficiency. This condition may occur due to being passed down through families (inherited). It may also be caused by a lack of vitamin K or by certain medical conditions (such as amyloidosis, liver disease).

Factor X is a clotting factor in the blood that helps bleeding stop normally. People with little or no factor X are at risk for easy bruising, nose or mouth bleeds, heavy menstrual periods (women), bleeding longer after an injury/surgery, or sudden bleeding (such as in the joints, muscles, head, stomach/gut) without a clear cause.

Generic name: coagulation factor X
Pronunciation: (FAK-tor)
Drug class: Factor X
Therapeutic class: Hematological Agents

The following indications are listed for Coagadex:

• Hereditary Factor X Deficiency Disease

Also known as: Hereditary Stuart-Prower Deficiency Disease.