Ticagrelor
Dosing in kidney impairment
Renal Impairment No dosage adjustment is needed in patients with renal impairment [see Clinical Pharmacology] . Patients with End-Stage Renal Disease on dialysis Clinical efficacy and safety studies with ticagrelor did not enroll patients with end-stage renal disease (ESRD) on dialysis. In patients with ESRD maintained on intermittent hemodialysis, no clinically significant difference in concentrations of ticagrelor and its metabolite and platelet inhibition are expected compared to those observed in patients with normal renal function [see Clinical Pharmacology] .
It is not known whether these concentrations will lead to similar efficacy and safety in patients with ESRD on dialysis as were seen in PLATO, PEGASUS, THEMIS and THALES.
Dosing in liver impairment
Hepatic Impairment Ticagrelor is metabolized by the liver and impaired hepatic function can increase risks for bleeding and other adverse events. Avoid use of ticagrelor in patients with severe hepatic impairment. There is limited experience with ticagrelor in patients with moderate hepatic impairment; consider the risks and benefits of treatment, noting the probable increase in exposure to ticagrelor.
No dosage adjustment is needed in patients with mild hepatic impairment [ see Warnings and Precautions and Clinical Pharmacology].