MedPath

Antihemophilic factor human

Generic Name
Antihemophilic factor human
Brand Names
Hemofil, Koate, Wilate, Voncento
Drug Type
Biotech
Unique Ingredient Identifier
839MOZ74GK

Overview

Antihemophilic factor human, also known as Coagulation Factor VIII or Anti-Hemophilic Factor (AHF), is a non-recombinant, lyophilized concentrate of coagulation factor VIII, an endogenous protein and essential component of the coagulation cascade. Antihemophilic factor is manufactured with reduced amounts of von Willebrand Factor antigen (VWF:Ag) and purified from extraneous plasma-derived protein by affinity chromatography. The small amount of VWF:Ag is used to purify factor VIII complex and then removed from the final preparation. The final purified concentrate contains albumin as a stabilizer.. The complex was developed by CSL Behring or Baxter Healthcare Corporation and approved in the 90s. Endogenous Factor VIII is essential to the clotting process in the body due to its involvement in the clotting cascade where it is responsible for acting as a co-factor to Factor IX. Activation of Factor IX leads to a cascade of signals that results in activation of Factor X, which then results in the conversion of prothrombin to thrombin, and as a result, leads to the conversion of fibrinogen to fibrin, the fibrous protein that creates the scaffold of the clot. Replacement of Factor VIII is essential for the treatment of Hemophilia A, which is caused by mutations in the Factor VIII gene, leading to a functional deficiency or complete loss of protein. Congenital loss or deficiency of Factor VIII results in the physiologic impairment of the coagulation clotting cascade, and as a result, leads to easy bruising and bleeding. Bleeding can range in severity from minor concerns, such as nosebleeds, to more serious events such as hemorrhaging in the joints, brain, or digestive tract . Exogenous replacement of Factor VIII is currently the cornerstone of Hemophilia treatment and is used for the prophylaxis and control of bleeding episodes. Treatment has drastically improved since the 1960s when Factor VIII protein was primarily purified from human plasma, rather than being produced through recombinant DNA technology. Unfortunately, purification of protein from human plasma carries an increased risk of transmission of blood-borne diseases such as HIV and Hepatitis, which in part contributed to the Tainted Blood Scandal in the 1980s and 1990s . Other drug products with similar structure and function to Antihemophilic factor human include Moroctocog alfa, which is produced by recombinant DNA technology and is identical in sequence to endogenously produced Factor VIII, but does not contain the B-domain, which has no known biological function and Efmoroctocog alfa, which is a fully recombinant factor VIII-Fc fusion protein which has an extended half-life compared with conventional factor VIII due to conjugation to the dimeric Fc domain of human immunoglobulin G1, a long-lived plasma protein . Antihemophilic factor human is approved by the Food and Drug Administration for use in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes .

Background

Antihemophilic factor human, also known as Coagulation Factor VIII or Anti-Hemophilic Factor (AHF), is a non-recombinant, lyophilized concentrate of coagulation factor VIII, an endogenous protein and essential component of the coagulation cascade. Antihemophilic factor is manufactured with reduced amounts of von Willebrand Factor antigen (VWF:Ag) and purified from extraneous plasma-derived protein by affinity chromatography. The small amount of VWF:Ag is used to purify factor VIII complex and then removed from the final preparation. The final purified concentrate contains albumin as a stabilizer.. The complex was developed by CSL Behring or Baxter Healthcare Corporation and approved in the 90s. Endogenous Factor VIII is essential to the clotting process in the body due to its involvement in the clotting cascade where it is responsible for acting as a co-factor to Factor IX. Activation of Factor IX leads to a cascade of signals that results in activation of Factor X, which then results in the conversion of prothrombin to thrombin, and as a result, leads to the conversion of fibrinogen to fibrin, the fibrous protein that creates the scaffold of the clot. Replacement of Factor VIII is essential for the treatment of Hemophilia A, which is caused by mutations in the Factor VIII gene, leading to a functional deficiency or complete loss of protein. Congenital loss or deficiency of Factor VIII results in the physiologic impairment of the coagulation clotting cascade, and as a result, leads to easy bruising and bleeding. Bleeding can range in severity from minor concerns, such as nosebleeds, to more serious events such as hemorrhaging in the joints, brain, or digestive tract . Exogenous replacement of Factor VIII is currently the cornerstone of Hemophilia treatment and is used for the prophylaxis and control of bleeding episodes. Treatment has drastically improved since the 1960s when Factor VIII protein was primarily purified from human plasma, rather than being produced through recombinant DNA technology. Unfortunately, purification of protein from human plasma carries an increased risk of transmission of blood-borne diseases such as HIV and Hepatitis, which in part contributed to the Tainted Blood Scandal in the 1980s and 1990s . Other drug products with similar structure and function to Antihemophilic factor human include Moroctocog alfa, which is produced by recombinant DNA technology and is identical in sequence to endogenously produced Factor VIII, but does not contain the B-domain, which has no known biological function and Efmoroctocog alfa, which is a fully recombinant factor VIII-Fc fusion protein which has an extended half-life compared with conventional factor VIII due to conjugation to the dimeric Fc domain of human immunoglobulin G1, a long-lived plasma protein . Antihemophilic factor human is approved by the Food and Drug Administration for use in hemophilia A (classical hemophilia) for the prevention and control of hemorrhagic episodes .

Indication

The human antihemophilic factor is indicated for the cases of hemophilia A, also known as classical hemophilia for the prevention and control of hemorrhagic episodes. If surgery is needed in patients with hemophilia A there is a need of correction of the clotting abnormality. In this cases, the human antihemophilic factor may be administered followed by intermittent maintenance doses. The hemophilia A is characterized by the deficiency of the coagulation factor VIII that results in prolonged blood flow after injury or surgery as well as recurrent bleeding.

Associated Conditions

  • Hemorrhage

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code

No FDA products found

No FDA products found for this drug

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision
Voncento
EMEA/H/C/002493
Germany
N/A
Authorised
2013/08/12
N/A
16

Singapore Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
BERIATE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION 500IU/VIAL
CSL Behring GmbH (Manufacturer of drug product), CSL Behring GmbH (Diluent)
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
500 IU/vial
2019/08/07
SIN15772P
NUWIQ POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250 IU
INJECTION, POWDER, FOR SOLUTION
250 IU FVIII:C/vial
2020/04/01
SIN15920P
Octanate 500IU Powder and Solvent for Solution for Injection
INJECTION, POWDER, FOR SOLUTION
500 iu/10 ml vial
2004/02/06
SIN12513P
Haemoctin SDH 500 for injection 500 iu/vial
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
500iu/vial
2011/11/30
SIN14059P
FANHDI FOR INJECTION 500 iu/vial
INJECTION, POWDER, FOR SOLUTION
500 iu/vial
2001/05/17
SIN11523P
NUWIQ POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1000 IU
INJECTION, POWDER, FOR SOLUTION
1000 IU FVIII:C / vial
2020/04/01
SIN15922P
NUWIQ POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU
INJECTION, POWDER, FOR SOLUTION
500 IU FVIII:C / vial
2020/04/01
SIN15921P
IGANTET INJECTION 500 iu/2 ml
INJECTION
500 iu/2 ml
2004/06/24
SIN12557P
FANHDI FOR INJECTION 250 iu/vial
INJECTION, POWDER, FOR SOLUTION
250 iu/vial
2001/05/17
SIN11521P
FANHDI FOR INJECTION 1000 iu/vial
INJECTION, POWDER, FOR SOLUTION
1000 iu/vial
2001/05/17
SIN11522P

China Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import

No China products found

No China products found for this drug

Australia Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient

No Australia products found

No Australia products found for this drug

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