Identification
- Summary
Coagulation factor X human is a coagulation factor used to treat Factor X deficiency to control bleeding.
- Brand Names
- Balfaxar, Beriplex, Coagadex, Kcentra, Octaplex
- Generic Name
- Coagulation factor X human
- DrugBank Accession Number
- DB13148
- 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 2. 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 1. 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 4.
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Blood factors - Protein Structure
- Protein Chemical Formula
- Not Available
- Protein Average Weight
- 59000.0 Da
- Sequences
- Not Available
- Synonyms
- Coagulation factor X
- Coagulation factor X (human)
- Factor X
- Factor X (stuart prower factor)
- Human coagulation factor X
- Stuart-prower factor
Pharmacology
- 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.4
Along with other blood coagulation factors, it is used to reverse acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with a need for an urgent surgery/invasive procedure.5,6
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Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to reverse Acquired coagulation factor deficiency Combination Product in combination with: Coagulation Factor IX Human (DB13152), Protein S human (DB13149), Prothrombin (DB11311), Protein C (DB11312), Coagulation factor VII human (DB13150) •••••••••••• ••••• ••••• ••••• •••••••• Management of Bleeding •••••••••••• ••••••••••• •••••• ••••••••• Management of Bleeding •••••••••••• ••••••••••• •••••• ••••••••• Prophylaxis of Bleeding •••••••••••• ••••••••••• •••••• ••••••••• - Associated Therapies
- Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
Clinical human coagulation Factor X solution increases plasma levels of Factor X and can temporarily correct the coagulation defect in these patients, as reflected by decrease in the activated Partial Thromboplastin Time (aPTT) and prothrombin time (PT) 4.
- Mechanism of action
Factor X is an inactive zymogen that is synthesized in the liver, which can be activated by Factor IXa (via the intrinsic pathway) or by Factor VIIa (via the extrinsic pathway). It is composed of a light chain which contains the Gla (glutamic acid) domain and two epidermal growth factor domains, and a heavy chain that contains the catalytic serine protease domain 1. The conversion of inactive Factor X into the active form Factor Xa requires the cleavage of a 52-residue peptide from the heavy chain 4 and the release of 52-residue activation peptide that contains the His236, Asp228 and Ser379 catalytic site. This activation step can occur through the extrinsic or intrinsic pathway and is considered to be the first step in the common pathway to fibrin formation 1.
Factor Xa plays a critical initiation step of the coagulation pathway by cleaving and activating prothrombin to thrombin in complex with FVa, Ca2+ and phospholipids. This complex is also known as the prothrombinase complex. Thrombin then acts upon soluble fibrinogen and Factor XIII to generate a cross-linked fibrin clot 3,4.
- Absorption
Following a single intravenous dose of 25 IU/kg, the mean peak plasma concentration (CV%) was 0.504 (17.2) IU/mL 4.
- Volume of distribution
Following a single intravenous dose of 25 IU/kg, the mean volume of distribution at steady state (CV%) was 56.3 (24.0) mL/kg 4.
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Following a single intravenous dose of 25 IU/kg, the mean plasma half-life (CV%) was 30.3 (22.8) hr.4
- Clearance
Following a single intravenous dose of 25 IU/kg, the mean total body clearance was 1.35 (21.7) mL/kg/hr.4
- Adverse Effects
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Not Available
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- Drug Interactions
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with Abciximab. Acenocoumarol The therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with Acenocoumarol. Alpha-1-proteinase inhibitor Alpha-1-proteinase inhibitor may increase the thrombogenic activities of Coagulation factor X human. Alteplase The therapeutic efficacy of Coagulation factor X human can be decreased when used in combination with Alteplase. Aminocaproic acid The risk or severity of adverse effects can be increased when Aminocaproic acid is combined with Coagulation factor X human. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Coagadex Injection, powder, lyophilized, for solution; Kit 100 [iU]/1mL Intravenous Bio Products Laboratory Limited 2015-10-21 Not applicable US 
Coagadex Injection, powder, for solution 500 IU Intravenous Bpl Bioproducts Laboratory Gmb H 2020-12-21 Not applicable EU 
Coagadex Injection, powder, lyophilized, for solution; Kit 100 [iU]/1mL Intravenous Bio Products Laboratory Limited 2015-10-21 Not applicable US Coagadex Injection, powder, for solution 250 IU Intravenous Bpl Bioproducts Laboratory Gmb H 2020-12-21 Not applicable EU - Mixture Products
Name Ingredients Dosage Route Labeller Marketing Start Marketing End Region Image Balfaxar Coagulation factor X human (24 [iU]/1mL) + Coagulation Factor IX Human (25.5 [iU]/1mL) + Coagulation factor VII human (16.5 [iU]/1mL) + Protein C (22 [iU]/1mL) + Protein S human (22 [iU]/1mL) + Prothrombin (26 [iU]/1mL) Powder, for solution Intravenous Octapharma USA Inc 2023-11-30 Not applicable US Beriplex P/n 1000 Coagulation factor X human (2040 unit) + Coagulation Factor IX Human (1240 unit) + Coagulation factor VII human (1000 unit) + Protein C (1640 unit) + Protein S human (1360 unit) + Prothrombin (1600 unit) Powder, for solution Intravenous Csl Behring 2013-11-21 Not applicable Canada 
Beriplex P/N 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Coagulation factor X human (1640 IE) + Coagulation Factor IX Human (1020 IE) + Coagulation factor VII human (700 IE) + Protein C (1200 I.E.) + Protein S human (1000 IE) + Prothrombin (1360 IE) Injection, powder, for solution Parenteral Csl Behring 2013-04-16 Not applicable Austria 
Beriplex P/N 250 I.E. Pulver und Lösungsmittel zur Herstellung einer Injektionslösung Coagulation factor X human (410 IE) + Coagulation Factor IX Human (255 IE) + Coagulation factor VII human (175 IE) + Protein C (300 IE) + Protein S human (250 IE) + Prothrombin (340 I.E.) Injection, powder, for solution Parenteral Csl Behring 2008-02-27 Not applicable Austria Beriplex P/n 500 Coagulation factor X human (1020 unit) + Coagulation Factor IX Human (620 unit) + Coagulation factor VII human (500 unit) + Protein C (820 unit) + Protein S human (680 unit) + Prothrombin (800 unit) Powder, for solution Intravenous Csl Behring 2011-07-28 Not applicable Canada
Categories
- ATC Codes
- B02BD13 — Coagulation factor x
- Drug Categories
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Humans and other mammals
Chemical Identifiers
- UNII
- HYF6HN9XGQ
- CAS number
- Not Available
References
- General References
- Brown DL, Kouides PA: Diagnosis and treatment of inherited factor X deficiency. Haemophilia. 2008 Nov;14(6):1176-82. doi: 10.1111/j.1365-2516.2008.01856.x. [Article]
- Venkateswarlu D, Perera L, Darden T, Pedersen LG: Structure and dynamics of zymogen human blood coagulation factor X. Biophys J. 2002 Mar;82(3):1190-206. doi: 10.1016/S0006-3495(02)75476-3. [Article]
- Palta S, Saroa R, Palta A: Overview of the coagulation system. Indian J Anaesth. 2014 Sep;58(5):515-23. doi: 10.4103/0019-5049.144643. [Article]
- FDA Approved Drug Products: COAGADEX (Coagulation Factor X (Human)) Lyophilized Powder for Solution for Intravenous Injection [Link]
- FDA Approved Drug Products: KCENTRA (Prothrombin Complex Concentrate (Human)) For Intravenous Use, Lyophilized Powder for Reconstitution [Link]
- FDA Approved Drug Products: BALFAXAR (prothrombin complex concentrate, human-lans) lyophilized powder for solution, for intravenous use (July 2023) [Link]
- External Links
Clinical Trials
- Clinical Trials
Phase Status Purpose Conditions Count 4 Completed Treatment Bleeding / Blood Loss During Surgery / Cardiovascular Surgical Procedures / Fresh Frozen Plasma / Prothrombin Complex Concentrates 1 4 Recruiting Treatment Coagulation Disorder / Massive Hemorrhage / Traumatic haemorrhage 1 4 Withdrawn Treatment Postpartum Haemorrhage (PPH) 1 3 Completed Prevention Factor X Deficiency 1 3 Completed Treatment Acute Major Bleeding / Coagulation Disorder 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, for solution Intravenous Injection, powder, for solution Intravenous 100 UI/ML Injection, powder, for solution Intravenous 250 IU Injection, powder, for solution Intravenous 500 IU Injection, powder, lyophilized, for solution; kit Intravenous 100 [iU]/1mL Injection Intravenous Powder, for solution Intravenous Injection, powder, lyophilized, for solution; kit Intravenous Powder, for solution Parenteral Kit; powder, for solution Intravenous Injection, powder, for solution Intravenous drip 520 IU/vial Injection, powder, for solution Parenteral Solution Intravenous - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Drug created at November 18, 2016 20:47 / Updated at April 22, 2024 18:19