Coagulation Factor X (Human), is a plasma-derived human blood coagulation factor is used by adults and children (aged 12 years and above) with hereditary Factor X deficiency. However its use is limited in the perioperative setting for the management of bleeding in major surgery in patients with moderate and severe hereditary Factor X deficiency. Coagulation Factor X is a vitamin K-dependent, liver-produced serine protease that serves as the first enzyme in the coagulation cascade to form fibrin. It is a two-chain glycoprotein with the molecular weight of approximately 59 kDa . While Factor X normally circulates in the plasma as inactive molecules, the activation of Factor X is involved in both the intrinsic and extrinsic coagulation pathways. Inherited factor X deficiency is a rare autosomal recessive bleeding disorder that is estimated to occur in 1:1 000 000 individuals up to 1:500 carriers . Administration of coagulation Factor X from healthy donor serves to restore and achieve effective hemostasis. Coagulation Factor X (Human) solution is approved by the FDA for intravenous injection under the market name Coagadex which contains normally 100 IU/mL of coagulation Factor X derived from healthy donors who have passed viral screening tests .
Coagulation Factor X (Human), is a plasma-derived human blood coagulation factor is used by adults and children (aged 12 years and above) with hereditary Factor X deficiency. However its use is limited in the perioperative setting for the management of bleeding in major surgery in patients with moderate and severe hereditary Factor X deficiency. Coagulation Factor X is a vitamin K-dependent, liver-produced serine protease that serves as the first enzyme in the coagulation cascade to form fibrin. It is a two-chain glycoprotein with the molecular weight of approximately 59 kDa . While Factor X normally circulates in the plasma as inactive molecules, the activation of Factor X is involved in both the intrinsic and extrinsic coagulation pathways. Inherited factor X deficiency is a rare autosomal recessive bleeding disorder that is estimated to occur in 1:1 000 000 individuals up to 1:500 carriers . Administration of coagulation Factor X from healthy donor serves to restore and achieve effective hemostasis. Coagulation Factor X (Human) solution is approved by the FDA for intravenous injection under the market name Coagadex which contains normally 100 IU/mL of coagulation Factor X derived from healthy donors who have passed viral screening tests .
The human coagulation factor X is indicated in adults and children with hereditary Factor X deficiency for routine prophylaxis to reduce the frequency of bleeding episodes, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding in patients with mild and moderate hereditary Factor X deficiency. It is also indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.
Title | Posted | Study ID | Phase | Status | Sponsor |
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2017/05/22 | N/A | Completed | Bio Products Laboratory |
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No FDA products found for this drug
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
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EMEA/H/C/003855 | Germany | Orphan | Authorised | 2016/03/16 | 2016/01/28 | 10 |
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval Number |
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INJECTION, POWDER, FOR SOLUTION | 360 - 600 IU/vial | 2016/01/28 | SIN14933P |
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No NMPA products found for this drug
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No PPB products found for this drug
Product Name | ARTG ID | Sponsor | Status | Registration Date | Ingredient |
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73393 | Active | 2000/03/02 | Factor X | ||
328514 | Active | 2020/07/07 | Factor X | ||
149949 | Active | 2008/02/07 | Factor X | ||
189134 | Active | 2011/09/12 | Factor X | ||
156330 | Active | 2010/02/05 | Factor X | ||
328516 | Active | 2020/07/07 | Factor X | ||
124381 | Active | 2006/01/30 | Factor X | ||
328515 | Active | 2020/07/07 | Factor X | ||
156459 | Active | 2010/02/05 | Factor X | ||
129151 | Octapharma Australia Pty Ltd | Active | 2007/10/12 | Factor X |