POWERED BY PLASMA

To meet your patient's hemophilia A treatment goals1

KOĀTE is a well-established treatment option for hemophilia A1

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

*FVIII: factor VIII; VWF: von Willebrand factor

Helps to restore the integrity of the coagulation cascade1

KOĀTE temporarily replaces the missing clotting Factor VIII that is needed for effective hemostasis.1

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

No two plasma-derived therapies are exactly alike2

During KOĀTE’s proprietary manufacturing process, the FVIII and co-purified VWF are separated from unwanted plasma proteins to form a combination specific to KOĀTE.1-3

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

No two people will respond exactly the same way to a single therapy2

KOĀTE has a 16.1 hour mean biologic half-life1

16.1 Hours

KOĀTE contains naturally occurring VWF1*

*KOĀTE is not indicated for the treatment of von Willebrand disease or congenital thrombotic thrombocytopenic purpura (cTTP).

ADAMTS13: a disintegrin and metalloproteinase with a thrombospondin type 1 motif 13.

In the body, VWF4:

  • Transports FVIII to the site of injury
  • Protects FVIII from protease inactivation
  • Prolongs the plasma half-life of FVIII

When bound to FVIII, VWF is thought to:

  • Provide an immunoprotective effect by blocking FVIII endocytosis and subsequent T-cell presentation5
  • Reduce FVIII immunogenicity by masking inhibitor epitope sites in the A3 and C2 domains6

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

KOĀTE Clinical Study Experience

16.1 16.1 hour mean biologic half-life1

0.66% A low risk of side effects per infusion (7 of 1053 infusions in the clinical study)1*

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

82% 82% of bleeds were treated with a single KOĀTE dose in the clinical study of 19 patients (n=306 bleeds).1†

†Dose and duration of treatment depend on the severity of the FVIII deficiency, location and extent of bleeding, and the patient’s clinical condition.

0 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.7‡

The formation of inhibitors to KOĀTE may occur. Monitor all patients for the development of FVIII inhibitors by clinical observation and laboratory tests.

The observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, it may be misleading to compare the incidence of antibodies to KOĀTE in the study described above with the incidence of antibodies in other studies or to other products.

When to THINK KOĀTE

Severe Hemophilia A Patient? Newly-Exposed FVIII Patient?

In a 2-stage safety, pharmacokinetic, and efficacy clinical trial of 19 patients, 82% of bleeds were treated with a single dose of KOĀTE (n=306 bleeds).1||

§Newly-exposed FVIII patients include previously untreated or minimally treated patients who are within their first 50 exposure days. Note that KOĀTE has not been studied in children younger than 2.5 years.

||Dose and duration of treatment depend on the severity of the FVIII deficiency, location and extent of bleeding, and the patient’s clinical condition.

Non-severe Patient Undergoing Surgery?

The prevention of inhibitors during surgical procedures is an important consideration when treating non-severe patients not regularly exposed to FVIII.8

Non-severe hemophilia A patients account for about 40% of all hemophilia A cases, making up a significant portion of the patient population.9

Inhibitors, while occurring less frequently in this population than in severe patients, pose a lifelong threat.8,10

  • Non-severe patients may not reach 50 exposure days (EDs) until well into adulthood.11
  • Inhibitor risk for non-severe patients continues to increase beyond 50 EDs.8

Inhibitors are particularly devastating in mild patients where they frequently cross-react with endogenous FVIII, converting these patients into a severe bleeding phenotype (FVIII:C < 0.01 IU/mL).12

Exposure to high-dose FVIII treatment during surgery is one of several factors that has been linked to increased risk of inhibitor development in patients with non-severe hemophilia A.8

Treatment Challenges of Hemophilia A

Inhibitors to Factor VIII (i.e., anti-FVIII antibodies) heighten the complexity and uncertainty of preventing and controlling bleeds in people with hemophilia A.13

Inhibitor eradication is an important consideration for improving patient safety and achieving reliable hemostasis.13

Treatment guidelines suggest that using repeated doses of FVIII concentrate administered frequently on a predetermined schedule may result in eradication of the FVIII inhibitor.13 No single product or dosage regimen has been accepted as the most effective.13