Cases of less-than-expected FVIII activity in previously treated patients during post-marketing surveillance of N8-GP.
Johannes OldenburgGary BensonTakashi NakanoSusan HalimehTadashi MatsushitaAnne NørlandMohd Nawi WahidLaszlo NemesPublished in: Haemophilia : the official journal of the World Federation of Hemophilia (2023)
In conclusion, the 14 reported cases of less-than-expected FVIII activity, without presence of detectable FVIII inhibitors, presented with heterogenous characteristics, and wide variations in FVIII activity and anti-PEG antibody titre. FVIII activity returned to the expected range after switching to alternative FVIII products. In line with WFH guidelines, monitoring of FVIII activity can ensure FVIII activity in the expected range. The safety surveillance of N8-GP continues.