It was originally approved by the U.S. Food and Drug Administration (FDA) in 1993. In 2000, a new formulation of Kogenate in sucrose solution, called Kogenate FS, was approved. Kogenate FS reduces the medication’s infusion time since it is being supplied at a higher concentration.
How does Kogenate work?
Hemophilia A is a bleeding disorder caused by a mutation in the F8 gene that impairs the production or function of a blood-clotting protein called factor VIII (FVIII).
Kogenate contains octocog alfa, a recombinant, or man-made, version of human FVIII. The medication is designed to replace the missing FVIII protein in the blood of hemophilia A patients, and works to control and prevent bleeds. It also can be used to reduce the risk of joint damage in children, and to lower the risk of excessive bleeding during surgery.
The medication is produced by providing cells derived from hamsters, and grown in the laboratory, with a copy of the human F8 gene. Cells produce the protein that is then harvested and purified for human use.
Kogenate in clinical trials
Kogenate FS was approved after a trial assessed its safety and effectiveness in 71 patients. Results demonstrated that Kogenate FS was effective in managing bleeds in patients with hemophilia A, and was well-tolerated with no significant adverse effects (side effects).
The medication’s approval for routine prophylaxis was based on data from the Phase 3 SPINART trial (NCT00623480). The randomized, open-label study assessed the safety and efficacy of the therapy in 84 males, ages 15–50, who were randomly assigned to receive on-demand or prophylactic treatment with Kogenate for at least one year.
Results demonstrated that after a median of 1.7 years of treatment, patients given Kogenate as a prophylactic had a significantly lower median number of bleed episodes per year than those given on-demand treatment. The safety profile of prophylactic Kogenate was similar to on-demand treatment.
Kogenate is given as an intravenous (into-the-vein) infusion. The therapy is available as a powder in single-use vials containing 250, 500, 1,000, 2,000, and 3,000 international units (IU).
Treatment dosage and frequency are calculated based on the severity of the bleeding episode, or in anticipation of the type of surgery a patient needs.
For routine prophylaxis in adults, a dosage of 25 IU per kg of body weight (IU/kg) should be given three times a week. Children should take the same dose, but every other day.
Common side effects associated with Kogenate include infusion site reactions, skin hypersensitivity reactions, and infections associated with the placement of devices to access the vein.
Allergic reactions to Kogenate are possible, especially if a patient is allergic to mouse or hamster proteins. If this occurs, treatment should be stopped immediately and a healthcare provider should be contacted. Symptoms of an allergic reaction include rash, itching, tightness of the chest or the throat, difficulty breathing, light-headedness or dizziness, nausea, and a decrease in blood pressure.
Development of neutralizing antibodies, or inhibitors, against Kogenate may occur, which may prevent treatment from working properly.
Last updated: Feb. 10, 2022, by Teresa Carvalho MS
Hemophilia News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.