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 .
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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/05/22 | N/A | Completed | Bio Products Laboratory |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/16/2016 | ||
Authorised | 3/16/2016 | ||
Authorised | 3/16/2016 | ||
Authorised | 3/16/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| OCTAPLEX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU | SIN14933P | INJECTION, POWDER, FOR SOLUTION | 360 - 600 IU/vial | 1/28/2016 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| OCTAPLEX | octapharma pharmazeutika produktionsges m b h | 02294664 | Kit
,
Powder For Solution - Intravenous | 600 UNIT / VIAL | 7/8/2008 |
| BERIPLEX P/N 1000 | csl behring canada inc | 02410826 | Powder For Solution - Intravenous | 2040 UNIT | 11/21/2013 |
| FEIBA VH IMMUNO ANTI INHIBITOR | osterreichisches institut fur haemoderivate ges m.b.h. | 00609137 | Powder For Solution - Intravenous | null NIL / ML | 12/31/1986 |
| BERIPLEX P/N 500 | csl behring canada inc | 02359251 | Powder For Solution - Intravenous | 1020 UNIT | 7/28/2011 |
| OCTAPLEX | octapharma pharmazeutika produktionsges m b h | 02434970 | Powder For Solution
,
Kit - Intravenous | 1200 UNIT / VIAL | 8/11/2015 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| PROTHROMPLEX TOTAL 600 UI / 20 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 78913 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| COAGADEX 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1161087002 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| COMPLEJO PROTROMBINICO OCTAPHARMA 1000 UI POLVO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | Octapharma S.A. | 85721 | POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| BERIPLEX 1000 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 76961 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| OCTAPLEX 1000 UI POLVO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | Octapharma S.A. | 80417 | POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
| COFACT 250 IU POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 86489 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| COMPLEJO PROTROMBINICO OCTAPHARMA 500 UI POLVO Y DISOLVENTE PARA SOLUCION PARA PERFUSION | Octapharma S.A. | 85722 | POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Not Commercialized |
| BERIPLEX 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 69890 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
| COAGADEX 250 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1161087001 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
| OCTAPLEX, 500 UI POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE. | Octapharma S.A. | 66447 | POLVO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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