Lonsurf Disease Interactions

The pharmacokinetics of tipiracil have not been studied in patients with end stage renal disease.

No adjustment to the starting dosage of products containing the combination ingredients, trifluridine and tipiracil is recommended for patients with mild hepatic impairment. No clinically important differences in the mean exposures of trifluridine and tipiracil were observed between patients with mild hepatic impairment to moderate hepatic impairment and patients with normal hepatic function. Caution is recommended when using these agents in patients with severe hepatic impairment as their pharmacokinetics have not been studied in these patients. Do not initiate in patients with baseline moderate or severe (total bilirubin >1.5 times ULN and any AST) hepatic impairment.

The use of products containing the combination ingredients, trifluridine and tipiracil may cause severe myelosuppression (Grade 3-4). It is recommended to monitor for signs and symptoms suspected of myelosuppression such as anemia, neutropenia, thrombocytopenia, and febrile neutropenia. Obtain complete blood counts prior to and on Day 15 of each cycle of the combination product containing trifluridine and tipiracil and more frequently as clinically indicated. Withhold the use of the agent for severe myelosuppression and resume at the next lower dosage according to the manufacturer instructions.

No adjustment to the starting dosage of products containing the combination ingredients, trifluridine and tipiracil is recommended for patients with mild or moderate renal impairment. The estimated mean AUC of trifluridine at steady state was 31% higher in patients with mild renal impairment and 43% higher in patients with moderate renal impairment than that in patient with normal renal function. The estimated mean AUC of tipiracil was 34% higher in patients with mild renal impairment and 65% higher in patients with moderate renal impairment than that in patients with normal renal function. Caution is recommended when using these agents in patient with severe renal impairment or end-stage renal disease as their pharmacokinetics have not been studied in these patients.