BfArM - Federal Institute for Drugs and Medical Devices

Navigation and service

Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.): In patients with moderate or severe renal impairment, uracil levels measured to determine dihydropyrimidine dehydrogenase (DPD) deficiency should be interpreted with caution.

Active substance: 5-Fluorouracil

The marketing authorisation holders of 5-fluorouracil containing medicines would like to inform that in patients with moderate or severe renal impairment, blood uracil levels used for dihydropyrimidine dehydrogenase (DPD) phenotyping should be interpreted with caution as there is an increased risk of misdiagnosis of DPD deficiency, which may lead to underdosing of 5-fluorouracil and thus reduced treatment efficacy.

Download DHPC/Information letter , Download_VeroeffentlichtAm_EN PDF, 338KB, File does not meet accessibility standards