KOĀTE CONTAINS NATURALLY OCCURRING VWF1

The FVIII/VWF* complex plays a key role in hemostasis. In the body, VWF2:

  •   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 presentation3
  •   Reduce FVIII immunogenicity by masking inhibitor epitope sites in the A3 and C2 domains4

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

MANUFACTURING KOĀTE

KOĀTE is a protein-rich plasma-derived complex1,5

VWF is co-purified with FVIII during the gel permeation chromatography step of manufacturing.1* This purification process yields a unique biologic.

  •   During manufacturing, the FVIII/VWF complex and similarly-sized proteins (or other proteins bound to the complex) are separated and collected from the plasma precipitate.1
  •   This creates a unique blend of proteins specific to KOĀTE.
  •   All plasma-derived factor products are unique biologics resulting from proprietary manufacturing processes.

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

Learn more about KOĀTE's manufacturing process

 
 
 
 
 

CLINICAL
DATA

 
 
 
In the clinical study of 19 patients, fewer than 1% of infusions (7 of 1053) were associated with an adverse reaction.1†
 
 
 
In the clinical study of 19 patients, 82% of bleeding episodes (n=306) were treated successfully with a single KOĀTE infusion.1*
 
 
 
 
 

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

The formation of inhibitors to KOĀTE may occur. Monitor all patients for the development of FVIII inhibitors by clinical observation and laboratory tests.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.
10 adverse reactions related to 7 infusions were reported in 4 out of 19 patients.
The median number of exposure days in the study was more than 50 days (range of 23–94).

TREATMENT CHALLENGES OF HEMOPHILIA A7

 
Inhibitors to FVIII (i.e., anti-FVIII antibodies) heighten the complexity and uncertainty of preventing and controlling bleeds in people with hemophilia A.
 
Tolerization is an important consideration for improving patient safety and achieving reliable hemostasis.
 
Treatment guidelines suggest that using repeated doses of FVIII concentrate administered frequently on a predetermined schedule may result in tolerization. No single product or dosage regimen has been accepted as the most effective.
References: 1. KOĀTE [prescribing information]. Fort Lee, NJ. Kedrion Biopharma Inc. 2018. 2. De Meyer SF, Deckmyn H, Vanhoorelbeke K. von Willebrand factor to the rescue. Blood. 2009;113(21):5049-57. 3. Dasgupta S, Repessé Y, Bayry J, et al. VWF protects FVIII from endocytosis by dendritic cells and subsequent presentation to immune effectors. Blood. 2007;109(2):610-2. 4. Franchini M, Lippi G. Von Willebrand factor-containing factor VIII concentrates and inhibitors in haemophilia A. Thromb Haemost. 2010;104(5):931-40. 5. Peyvandi F, Mannucci PM, Valsecchi C, et al. ADAMTS13 content in plasma-derived factor VIII/von Willebrand factor concentrates. Am J Hematol. 2013;88(10):895-8. 6. 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. 7. Valentino LA, Kempton CL, Kruse-Jarres R, et al. US Guidelines for immune tolerance induction in patients with haemophilia A and inhibitors. Haemophilia. 2015;21(5):559-677.
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