WHAT IS KOĀTE?

KOĀTE (Antihemophilic Factor (Human)) is a medicine used for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency).  KOĀTE is not approved for the treatment of von Willebrand disease.

KOĀTE is a plasma-derived factor VIII (FVIII) product, meaning that it is created from blood plasma donated by healthy people.1 You can learn more about KOĀTE's strict donor screening and manufacturing standards here.

FVIII is a clotting factor—one of several proteins in the blood that is required in order for your blood to clot. In people with hemophilia A, there is not enough working FVIII in the body to allow blood to clot properly. This is what causes people with hemophilia to bleed longer and more frequently than people with normal amounts of FVIII clotting factor in their blood.2

KOĀTE is a protein-rich FVIII/VWF replacement therapy that replaces missing or nonfunctional FVIII to help control and prevent bleeds in people with hemophilia A.2,3

 

FVIII + VWF WORK TOGETHER TO HELP BLOOD CLOT

WATCH THE SHORT VIDEO TO LEARN MORE ABOUT HOW FVIII AND VWF WORK TOGETHER IN THE CLOTTING PROCESS

In the body, FVIII is naturally bound to another clotting factor protein called von Willebrand factor (VWF).4*

VWF is an important protein that helps blood clot by binding to and stabilizing FVIII and transporting FVIII to the site of a bleed.4

KOĀTE is purified from human plasma and contains naturally occurring VWF, which is co-purified during the manufacturing process.3

*KOĀTE is not approved for the treatment of von Willebrand disease.

 

KEY KOĀTE CLINICAL STUDY DATA

 
 
 
 

On average, it takes 16.1 hours for the human body to use up half of the infused clotting factor. The exact half-life will vary from person to person.

 
 
 
 

In the clinical study of 19 patients, fewer than 1% of the infusions (7 of 1053) were associated with a side effect.*

* 10 side effects related to 7 infusions occurred in 4 out of 19 patients.
 
 
 

In the clinical study of 19 patients, 82% of bleeding episodes (251 of 306) were treated successfully with a single KOĀTE infusion.

 
 
 
 

In the clinical study, no evidence of inhibitor formation was observed in 34 previously treated patients over the course of 6 months of treatment.

The formation of inhibitors to KOĀTE may occur. Your doctor will monitor you for the development of FVIII inhibitors.
 
 
 

WHO CAN USE KOĀTE?

KOĀTE can be used to control and prevent bleeds in children, adolescents, and adults with hemophilia A. Whether you are newly diagnosed, new to FVIII therapy, or are on another FVIII product, KOĀTE may be able to help.

Ask your doctor about KOĀTE if:

  • You were (or your child was) recently diagnosed with hemophilia A
  • You are (or your child is) new to FVIII therapy
  • You are looking for an alternative to your (or your child's) current FVIII therapy

Ready to ask your doctor about KOĀTE?
Learn more about the KOĀTE TRY-IT Program here.

 
 

References: 1. Hemophilia Treatment. Centers for Disease Control and Prevention website. https://www.cdc.gov/ncbddd/hemophilia/treatment.html. Accessed June 1, 2018. 2. Basics About Hemophilia. Centers for Disease Control and Prevention website. https://www.cdc.gov/ncbddd/hemophilia/facts.html. Accessed June 1, 2018. 3. KOĀTE [prescribing information]. Fort Lee, NJ. Kedrion Biopharma Inc. 2018. 4. De Meyer SF, Deckmyn H, Vanhoorelbeke K. von Willebrand factor to the rescue. Blood. 2009;113(21):5049-57. 5. Powell JS, Bush M, Harrison J, et al. Safety and efficacy of solvent/detergent-treated antihaemophilic factor with an added 80°C terminal dry heat treatment in patients with haemophilia A. Haemophilia. 2000;6:140-149.

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