Hemophilia Resources
FAQ
- What is hemophilia?
- How many people have hemophilia?
- Who gets hemophilia?
- What is Kogenate® FS?
- How does Kogenate® FS work?
- What were the results of the clinical studies performed on Kogenate ® FS?
- How safe is Kogenate® FS?
- How is Kogenate® FS stored and what is the shelf life?
- What if I have more questions about Kogenate® FS?
What is hemophilia?
Hemophilia is a bleeding disorder caused by a deficiency of one of the blood clotting factors. Hemophilia A (often called classic hemophilia) is the result of a deficiency in clotting factor VIII and accounts for about 80% of all hemophilia cases. Hemophilia B (also called "Christmas disease" after Stephen Christmas, a British boy in the 20th century who was first diagnosed with it) is a deficiency in clotting factor IX, and is less common than hemophilia A. In both types of hemophilia, the clotting ability of the blood is impaired, resulting in excessive bleeding. Small wounds and punctures are usually not a problem for the person with hemophilia, but uncontrolled internal bleeding can result in pain and swelling and permanent damage, especially to joints and muscles.
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How many people have hemophilia?
One in 10,000 male babies will have hemophilia A. One in 34,500 men will have hemophilia B. Women may have hemophilia B, but it's very rare. About 17,000 Americans have hemophilia.
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Who gets hemophilia?
Both hemophilia A and hemophilia B are hereditary disorders. Both types are caused by an inherited sex-linked recessive trait with the defective gene located on the X chromosome. Females are carriers of this trait. Fifty percent of the male offspring of female carriers have the disease, and 50% of their female offspring are carriers. All female children of a male with hemophilia are carriers of the trait. One third of all cases of hemophilia A and one fifth of all cases of hemophilia B occur when there is no family history of the disorder. In these cases, hemophilia develops as the result of a new or spontaneous gene mutation.
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What is Kogenate® FS?
Kogenate® FS, Antihemophilic Factor (Recombinant), Formulated with Sucrose, is a drug used for the treatment of hemophilia A. Kogenate® FS is a recombinant factor VIII preparation that has been manufactured using recombinant DNA technology. The human FVIII gene is introduced into baby hamster kidney cells to produce Kogenate® FS in a complex manufacturing process that ensures its safety and purity. The way Kogenate® FS works is similar to the way FVIII made from human plasma works.
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How does Kogenate® FS work?
When a patient infuses Kogenate® FS, it works by temporarily replacing the clotting factor missing in hemophilia A (factor VIII), allowing the blood to clot to stop or prevent bleeding episodes.
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What were the results of the clinical studies performed on Kogenate ® FS?
There were two studies involving 71 patients with severe hemophilia A who had previously been treated with antihemophilic factor; 38 patients were in North America and 33 were in Europe. The studies set out to determine the safety and efficacy of Kogenate® FS and to demonstrate its similarity to Kogenate® Antihemophilic Factor (Recombinant), a product that has been used safely and effectively since it was licensed in 1993.1 In these studies Kogenate® FS was used as home treatment and also as prophylaxis prior to surgical procedures. Both studies found Kogenate® FS to be safe, effective, and similar to Kogenate® in controlling bleeding.
Other studies were also performed to assess the safety and efficacy of Kogenate® FS in previously untreated patients and minimally treated patients. Sixty-one infants and young children with severe hemophilia A (with a FVIII level of less than 2%) were enrolled, and they received over 1,700 prophylactic or on-demand infusions over a period of 45 months. Kogenate® FS demonstrated excellent hemostatic response in this study and was found to be safe and effective in infants and young children.
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How safe is Kogenate® FS?
A high-quality manufacturing process is used to produce Kogenate® FS ensuring its safety and purity. In the 15 years that Kogenate® has been used in treating hemophilia A, there has not been a single case of virus transmission. Kogenate® FS has been specially formulated to even further reduce the theoretical risk of virus exposure.
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How is Kogenate® FS stored and what is the shelf life?
Kogenate® FS should be stored in the refrigerator until you are ready to reconstitute it for an infusion. Do not freeze Kogenate® FS. Protect the vials from bright light by storing them in their carton before use. The expiration date of each vial of Kogenate® FS is indicated on the bottle.
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What if I have more questions about Kogenate® FS?
Your doctor or healthcare provider is the single best source of information regarding you and your health. Please consult your doctor if you have any questions about your health or medication. To contact Bayer HealthCare Customer Service in the USA during regular business hours, 8 am - 5pm Eastern Standard Time call: 1.800.243.4153
Or Contact our Customer Service Department.
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Remember, your doctor or healthcare provider is the single best source of information regarding you and your health. Please consult your doctor if you have any questions about your health, your symptoms, or your therapy.
1 Bodekar BG. The manufacturing of recombinant FVIII. Kogenate Med 1992;6(4):256-260.
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