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Direct Healthcare Professional Communication (DHPC) on irinotecan-containing drugs: Drug toxicity in patients with reduced UGT1A1 activity

Active substance: irinotecan hydrochloride 3 H2O

The marketing authorization holders of irinotecan-containing drugs, in coordination with the German Federal Institute for Drugs and Medical Devices (BfArM), inform that UGT1A1 genotyping may be helpful to identify patients at increased risk for severe neutropenia and diarrhea. Patients who are slow UGT1A1 metabolizers (for example, homozygous for UGT1A1*28 or *6 variants, as in Gilbert syndrome) are at increased risk for severe neutropenia and diarrhea after treatment with irinotecan. This risk increases with the dose of irinotecan.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 471KB, File is accessible