Overview
Rurioctocog alfa pegol is a pegylated recombinant human coagulation factor VIII or antihemophilic factor. Factor VIII is an essential protein involved in normal blood clotting; thus, a deficient level of functional factor VIII is associated with an elevated risk for excessive bleeding caused by spontaneous or secondary events like trauma or surgery. Hemophilia A is the most common inherited bleeding disorder leading to deficiency of factor VIII, which is caused by defects in the F8C gene that encodes coagulation factor VIII. Bleeding in joints is a common manifestation of hemophilia A, and bleeding episodes can be severe and life-threatening like intracranial hemorrhage. Rurioctocog alfa pegol aims to restore functional levels of factor VIII in patients with hemophilia A to manage and prevent bleeding episodes. It was first approved by the European Commission in January 2018. Rurioctocog alfa pegol is a covalent conjugate of octocog alfa, which is a recombinant factor VIII produced by recombinant DNA technology from a Chinese hamster ovary cell line. The presence of the polyethylene glycol (PEG) moiety increases the plasma half-life of the drug, thereby increasing the drug's duration of action.
Indication
Rurioctocog alfa pegol is indicated for the treatment and prophylaxis of bleeding in patients 12 years and above with hemophilia A (congenital factor VIII deficiency).
Associated Conditions
- Bleeding caused by Hemophilia A
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/09/13 | Phase 1 | Completed | |||
2016/12/30 | N/A | Completed | Spanish Society of Thrombosis and Haemostasis |
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 | 1/8/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
ADYNOVATE 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | SIN16051P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1500 IU | 11/24/2020 | |
ADYNOVATE 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | SIN16049P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 IU | 11/24/2020 | |
ADYNOVATE 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | SIN16050P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1000 IU | 11/24/2020 | |
ADYNOVATE 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | SIN16052P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 2000 IU | 11/24/2020 | |
ADYNOVATE 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | SIN16048P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 250 IU | 11/24/2020 | |
ADYNOVATE 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION | SIN16053P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 3000 IU | 11/24/2020 |
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 |
---|---|---|---|---|---|
ADYNOVATE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250IU/2ML | N/A | N/A | N/A | 2/27/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ADYNOVATE rurioctocog alfa pegol (rch) 250 IU powder for injection vial with diluent vial | 273517 | Medicine | A | 3/21/2017 | |
ADYNOVATE rurioctocog alfa pegol (rch) 2000 IU powder for injection vial with diluent vial | 278729 | Medicine | A | 3/21/2017 | |
ADYNOVATE rurioctocog alfa pegol (rch) 3000 IU powder for injection vial with diluent vial | 300852 | Medicine | A | 1/29/2019 | |
ADYNOVATE rurioctocog alfa pegol (rch) 1000 IU powder for injection vial with diluent vial | 278728 | Medicine | A | 3/21/2017 | |
ADYNOVATE rurioctocog alfa pegol (rch) 500 IU powder for injection vial with diluent vial | 278727 | Medicine | A | 3/21/2017 | |
ADYNOVATE rurioctocog alfa pegol (rch) 1500 IU powder for injection vial with diluent vial | 300851 | Medicine | A | 1/29/2019 | |
ADYNOVATE rurioctocog alfa pegol (rch) 750 IU powder for injection vial with diluent vial | 300850 | Medicine | A | 1/29/2019 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
ADYNOVI 3000 UI/5 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1171247016 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
ADYNOVI 250 UI/ 2 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1171247002 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Not Commercialized | |
ADYNOVI 2000 UI/5 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1171247014 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
ADYNOVI 500 UI/2 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1171247006 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | Uso Hospitalario | Commercialized | |
ADYNOVI 1000 UI/2 ML POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE | 1171247010 | POLVO Y DISOLVENTE PARA SOLUCIÓN INYECTABLE | 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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