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Rurioctocog alfa pegol

Generic Name
Rurioctocog alfa pegol
Brand Names
Adynovi
Drug Type
Biotech
CAS Number
1417412-83-9

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.

Background

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

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

ADYNOVATE 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Manufacturer:Baxalta Manufacturing Sarl (bulk production and primary packager), Siegfried Hameln GmbH (Diluent)
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:1500 IU
Online:Yes
Approved: 2020/11/24
Approval:SIN16051P
ADYNOVATE 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Manufacturer:Baxalta Manufacturing Sarl (bulk production and primary packager), Siegfried Hameln GmbH (Diluent)
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:500 IU
Online:Yes
Approved: 2020/11/24
Approval:SIN16049P
ADYNOVATE 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Manufacturer:Baxalta Manufacturing Sarl (bulk production and primary packager), Siegfried Hameln GmbH (Diluent)
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:1000 IU
Online:Yes
Approved: 2020/11/24
Approval:SIN16050P
ADYNOVATE 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Manufacturer:Baxalta Manufacturing Sarl (bulk production and primary packager), Siegfried Hameln GmbH (Diluent)
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:2000 IU
Online:Yes
Approved: 2020/11/24
Approval:SIN16052P
ADYNOVATE 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Manufacturer:Baxalta Manufacturing Sarl (bulk production and primary packager), Siegfried Hameln GmbH (Diluent)
Form:INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Strength:250 IU
Online:Yes
Approved: 2020/11/24
Approval:SIN16048P

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