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.
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
†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).