emPOWERED BY PLASMA

Help control and prevent bleeds with KOĀTE

KOĀTE is a plasma-derived FVIII co-purified with VWF1

KOĀTE is a naturally-occurring FVIII/VWF replacement therapy that is donated by healthy people.1,2 Human plasma is the straw-colored liquid portion of the blood.2

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

*FVIII: factor VIII; VWF: von Willebrand factor

Helps to restore the integrity of the coagulation cascade1

FVIII is a protein involved in the blood coagulation process.2

KOĀTE temporarily replaces the missing or non-functional FVIII to help control and prevent bleeds in people with hemophilia A.1

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

No two people will respond exactly the same way to a single therapy3

During manufacturing, the FVIII and co-purified VWF are separated from unwanted plasma proteins to form KOĀTE.1,3

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

No two plasma-derived therapies are exactly alike3

KOĀTE has a 16.1 hour mean biologic half-life1

16.1 Hours

Factor Check

The antihemophilic factor in KOĀTE temporarily replaces FVIII. Once infused, it lasts in your body for up to 16.1 hours.1

Understanding KOĀTE1

FVIII is 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 A to bleed longer and more frequently than people with normal amounts of FVIII clotting factor in their blood.4

FVIII is a clotting protein factor in the coagulation process4

VWF protects FVIII5*

In the body, FVIII is naturally bound to another clotting factor protein called von Willebrand factor (VWF).5*

VWF is an important protein that helps blood clot by binding to and protecting FVIII and transporting FVIII to the site of a bleed.5

FVIII & VWF work together to help blood clot5*

KOĀTE contains naturally occurring VWF1*

During manufacturing, the FVIII and co-purified VWF are separated from unwanted plasma proteins to form KOĀTE.1

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

Learn more about how FVIII and VWF work together in the clotting process

A well-established treatment option

Clinical Study Experience

0.66% low risk of adverse reactions per infusion1

A low risk of side effects per infusion (7 of 1053 infusions were associated with a side effect in the clinical study of 19 patients)1*

*10 adverse reactions related to 7 infusions were reported in 4 of 19 patients.

82% of bleeds were treated with a single dose1

82% of bleeding episodes (251 of 306) were treated with a single KOĀTE infusion in the clinical study of 19 patients.1

0 inhibitors formed1

Subjects were monitored for neutralizing antibodies (inhibitors) to Factor VIII and over the course of 6 months no evidence of inhibitor formation was observed during KOĀTE's clinical study.1,6†‡

Median number of exposure days was more than 50 days (range of 23-94).

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

When to use KOĀTE?

Diagnosis

KOĀTE has been studied in pediatric patients aged 2.5 to 16 years.1

Prevention

KOĀTE is indicated for the control and prevention of bleeding episodes.1

Surgery

KOĀTE is indicated in order to perform emergency and elective surgery in patients with hemophilia A.1

Major Bleedings/Inhibitors

For certain complications higher doses of FVIII may be recommended by your healthcare practitioner.1

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