Antihaemophilic Factor

Antihaemophilic Factor

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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.11. 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 6.

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 7.

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.12 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.11 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.9

The human antihemophilic factor assists in the convertion of prothrombin to thrombin.10 Its administration generates the formation of a complex constituted by the Factor IXa, Factor X and the antihemophilic factor which triggers the normal coagulation cascade for the formation of blood clots.1 The human antihemophilic factor is increased in the plasma thus enabling temporary correction of the hemophilia A bleeding.13 Its effect is reported as the normalization of the partial thromboplastin time.14

After intravenous administration of the human antihemophilic factor the values of Cmax, AUC and Tmax were 100 IU/ml, 1450 IU h/ml and 0.43 h respectively. In a second clinical trial, the treatment was administered for six months and the values of Cmax, AUC and Tmax were 99 units/ 100 ml, 1471 units h/ 100ml and 16 h, respectively.14

The pharmacokinetic profile of the human antihemophilic factor needed to be studied by the two-compartment theory as not all of it stays just in blood plasma. The central and peripheral volume of distribution in adults weight an average of 68 kg were 2.81 L and 1.90 L respectively.3

The metabolism of the human antihemophilic factor is identical to the normal inactivation and elimination pathway of the natural coagulation factor VIII. After activation, the human antihemophilic factor gets metabolized by activated protein C in R336 and R562 and this action inactivates this cofactor. The proteolysis generates two major fragments which are recognized by an anti-factor VIII A2 domain antibody. This process is followed by a further degradation into smaller fragments.4

The reported clearance for the administration of antihemophilic factor is 0.15 L/h in adults with an average weight of 68 kg. In the same study, there was a separation of the intercompartment clearance which is 0.16 L/h. The clearance rate was reported to be significantly decreased with increasing age and significantly increased in patients that presented a blood type of gourp O.3

Antihemophilic factor (AHF) injection is used to treat and control serious bleeding episodes in patients with a bleeding problem called hemophilia A (congenital Factor VIII deficiency). The bleeding episode may be related to an injury (trauma) or a surgical procedure. It is also used to reduce the number of bleeding episodes in patients when used regularly. AHF injection is also used to prevent bleeding during a surgical procedure.

We make Esperoct [antihemophilic factor (recombinant), glycopegylated-exei] by taking the existing Novoeight molecule and adding PEGylation technology to extend its half-life. Are you interested in up to 50% fewer infusions and factor levels that stay at or above 3% for 100% of the timeb,c

bTrough level goal is 1% for prophylaxiscData shown are from a study where 175 previously treated adolescents and adults received routine prophylaxis with Esperoct 50 IU/kg every 4 days for 76 weeks. Pre-dose factor activity (trough) levels were evaluated at follow-up visits. Mean trough levels for adolescents (12-

Esperoct [antihemophilic factor (recombinant), glycopegylated-exei] is an injectable medicine to treat and prevent or reduce the number of bleeding episodes in people with hemophilia A. Your healthcare provider may give you Esperoct when you have surgery

Novoeight (antihemophilic factor, recombinant) is an injectable medicine used to control and prevent bleeding in people with hemophilia A. Your healthcare provider may give you Novoeight when you have surgery

If you appreciate the bleed control and 104F storage temperature of Novoeight, then you might want to explore Esperoct, the latest factor VIII treatment from Novo Nordisk, which also has a 104F storage temperature. And Esperoct offers a longer half-life compared to standard half-life products, which means fewer infusions for you.

Antihemophilic factor is a naturally occurring protein in the blood that helps blood to clot. A lack of antihemophilic factor VIII is the cause of hemophilia A. Human antihemophilic factor works by temporarily raising levels of factor VIII in the blood to aid in clotting.

Carefully follow all instructions about how to store this medicine. Each brand of human antihemophilic factor may have specific instructions about keeping the medicine in a refrigerator or at room temperature, and for only a certain number of months.

Some brands of human antihemophilic factor are not approved for use by anyone younger than 18 years old. Ask your pharmacist if you have any questions about the specific brands of this medicine.

Human antihemophilic factor is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Follow all directions on your prescription label. Do not use antihemophilic factor in larger or smaller amounts or for longer than recommended. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Human antihemophilic factor is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Human antihemophilic factor is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Human antihemophilic factor is sometimes used only as needed, so you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Other drugs may interact with human antihemophilic factor, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Of the 73 previously untreated patients in the study, 73 patients with Factor VIII levels less than or equal to 2% received at least 1 infusion of RECOMBINATE and were tested for an inhibitor after treatment. During the study, 23 patients developed inhibitors to factor VIII. Of these patients, 13 displayed no detectable factor VIII inhibitors at study exit.1

This medication is used to control and prevent bleeding episodes in people with low levels of factor VIII (hemophilia A). It is also used in these patients before surgery to prevent bleeding. People with low factor VIII levels are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains human factor VIII, also called antihemophilic factor. This product is used to temporarily replace the missing factor VIII, a protein (clotting factor) that is normally in the blood, so that the blood can clot and the b