Revised SPC: Xermelo (telotristat ethyl) 250 mg film-coated tablets

Data from 2 studies in hepatic impairment (HI) have been added to SPC and based on these findings, a reduction in dose may be necessary in patients with mild/moderate HI (respectively Child Pugh score A and B) and use is not recommended in severe HI (Child Pugh score C).


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