Last updated Jan. 11, 2023, by Teresa Carvalho, MS
✅ Fact-checked by Joana Carvalho, PhD
What is Kogenate for Hemophilia?
Kogenate (octocog alfa) was an approved treatment to control and prevent bleeding episodes in people with hemophilia A that has now been discontinued.
The therapy was developed and marketed by Bayer. The company, however, has stopped its production of the medication, noting a “shift” from the use of standard half-life treatments like Kogenate to extended half-life products, such as Kovaltry and Jivi.
Bayer is working to support patients during their transition to other formulations.
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 was 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.
Who can take Kogenate?
Kogenate 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 reduced the medication’s infusion time as it was being supplied at a higher concentration.
In 2008, Kogenate FS was approved as a routine prophylactic, or preventive treatment for hemophilia A in children. The approval for the same indication in adults came in 2014.
Who should not take Kogenate?
Kogenate was not designed for use by patients who have allergic reactions, including severe and potentially life-threatening reactions, to:
- mouse or hamster proteins.
- other constituents of the product, such as sucrose, glycine, histidine, sodium, calcium chloride, polysorbate 80, imidazole, tri-n-butyl phosphate, and copper.
The therapy was not indicated for the treatment of von Willebrand disease, another inherited bleeding disorder.
How is Kogenate administered?
Kogenate was given as an intravenous (into-the-vein) injection. The therapy was 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 were calculated based on the severity of the bleeding episode, or in anticipation of the type of surgery a patient required.
For routine prophylaxis in adults, a dosage of 25 IU per kilogram of body weight (IU/kg) was prescribed, to be given three times a week. Children were prescribed the same dose, but every other day.
For the control and treatment of bleeds, patients were given:
- a dose of 10 to 20 IU/kg, to be taken until the bleed was resolved (with a dose repetition if needed), in the case of minor bleeds.
- a dose of 15 to 30 IU/kg, to be administered every 12–24 hours until the bleed was resolved, in the case of moderate bleeds.
- an initial dose of 40 to 50 IU/kg, followed by a dose of 20 to 25 IU/kg given every 8–12 hours until the bleed was resolved, in the case of major bleeds.
For minor surgical procedures, a dose of 15 to 30 IU/kg was slated to be given every 12–24 hours until bleeding was resolved. For major surgical procedures, a dose of 50 IU/kg was to be given every 6–12 hours to maintain FVIII levels in the desired range until healing was complete.
The therapy was designed to be reconstituted (diluted) before administration with the components provided with its package.
Kogenate was not to be frozen, but stored at 2 C to 8 C (36 F to 46 F) for up to 30 months from the date of manufacture. Within that period, the medication might be stored for up to 12 months at temperatures up to 25 C, or 77 F.
After reconstitution, Kogenate FS would be stored at room temperature before being administered, which was expected to occur within a period of three hours. Injection usually took between one and 15 minutes and the rate of administration was adapted to each patient’s response.
Kogenate in clinical trials
Kogenate FS trial
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).
SPINART trial
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 12–50, who were randomly assigned to receive on-demand or prophylactic treatment with Kogenate FS for at least one year.
Results demonstrated that after a median of 1.7 years of treatment, patients given Kogenate as a prophylactic treatment 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 that of on-demand treatment.
Common side effects of Kogenate
Common side effects associated with Kogenate included:
- infusion site reactions.
- skin hypersensitivity reactions.
- infections associated with the placement of devices to access veins.
Allergic reactions
Allergic reactions to Kogenate were possible, especially if a patient was allergic to mouse or hamster proteins. If this occurred, treatment was to be stopped immediately and a healthcare provider contacted.
Symptoms of an allergic reaction might have included rash, itching, tightness of the chest or throat, difficulty breathing, light-headedness or dizziness, nausea, and a decrease in blood pressure.
Development of inhibitors
Development of neutralizing antibodies, or inhibitors, against Kogenate also could occur, which had the potential to prevent the treatment from working as intended.
Patients were to be regularly monitored for the possible development of inhibitors. Tests to check for the presence of inhibitors were to be performed if bleeding did not stop after treatment, or if FVIII activity levels failed to be attained.
Use in pregnancy and breastfeeding
It was unknown if Kogenate could affect a developing fetus during pregnancy or pass to breast milk. Patients who were pregnant, planned to become pregnant, or breastfeed should have discussed the potential benefits and risks with their healthcare team.
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