UK Medicines Information
PRAC recommends further assessment of risk of developing inhibitors with Kogenate Bayer/Helixate NexGen (factor VIII)
Information type:
Safety alerts
Source:
European Medicines Agency
Specialities:
Haematological disorders
Summary
The PRAC is recommending further examination of the available evidence for Kogenate Bayer/Helixate NexGen, as new evidence has shown it may be associated with a higher risk of inhibitor (antibody) development than other FVIII products in treatment-naïve haemophilia patients.
UKMi comment
There is currently no related MHRA guidance available.
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