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Coagulation factor X human

Generic Name
Coagulation factor X human
Brand Names
Balfaxar, Beriplex, Coagadex, Kcentra, Octaplex
Drug Type
Biotech
Unique Ingredient Identifier
HYF6HN9XGQ

Overview

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 .

Background

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 .

Indication

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.

Associated Conditions

  • Acquired Coagulation Factor Deficiency
  • Bleeding

Clinical Trials

FDA Approved Products

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Manufacturer
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Approved
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No FDA products found

No FDA products found for this drug

EMA Approved Products

Product Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision
EMEA/H/C/003855
Germany
Orphan
Authorised
2016/03/16
2016/01/28
10

HSA Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval Number
INJECTION, POWDER, FOR SOLUTION
360 - 600 IU/vial
2016/01/28
SIN14933P

NMPA Approved Products

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Import

No NMPA products found

No NMPA products found for this drug

PPB Approved Products

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No PPB products found

No PPB products found for this drug

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