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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 .

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
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Sponsor

No clinical trials found

No clinical trials found for this drug

FDA Drug Approvals

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NDC Code
Route
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Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
8/12/2013

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
BERIATE POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR INFUSION 500IU/VIAL
SIN15772P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
500 IU/vial
8/7/2019
NUWIQ POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250 IU
SIN15920P
INJECTION, POWDER, FOR SOLUTION
250 IU FVIII:C/vial
4/1/2020
Octanate 500IU Powder and Solvent for Solution for Injection
SIN12513P
INJECTION, POWDER, FOR SOLUTION
500 iu/10 ml vial
2/6/2004
Haemoctin SDH 500 for injection 500 iu/vial
SIN14059P
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
500iu/vial
11/30/2011
FANHDI FOR INJECTION 500 iu/vial
SIN11523P
INJECTION, POWDER, FOR SOLUTION
500 iu/vial
5/17/2001
NUWIQ POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1000 IU
SIN15922P
INJECTION, POWDER, FOR SOLUTION
1000 IU FVIII:C / vial
4/1/2020
NUWIQ POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU
SIN15921P
INJECTION, POWDER, FOR SOLUTION
500 IU FVIII:C / vial
4/1/2020
IGANTET INJECTION 500 iu/2 ml
SIN12557P
INJECTION
500 iu/2 ml
6/24/2004
FANHDI FOR INJECTION 250 iu/vial
SIN11521P
INJECTION, POWDER, FOR SOLUTION
250 iu/vial
5/17/2001
FANHDI FOR INJECTION 1000 iu/vial
SIN11522P
INJECTION, POWDER, FOR SOLUTION
1000 iu/vial
5/17/2001

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
HAEMOCTIN SDH 250 POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 250IU
N/A
N/A
N/A
7/22/2011

TGA Drug Approvals

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Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

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Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

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Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

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No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

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Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

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MA Holder
MA Number
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Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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