Valturna and Renal impairment

Renal function should be monitored periodically in patients treated with aliskiren, as changes can occur including acute renal failure. Patients on aliskiren whose renal function may depend in part of the RAAS (renin-angiotensin-aldosterone system), such as patients with renal artery stenosis, severe heart failure, or postmyocardial infarction may be at higher risk for developing acute renal failure. Treatment should be discontinued in any patients who develop clinically significant decrease in renal function. Patients with renal impairment should be observed closely. The safety and effectiveness of aliskiren have not been established in patients with severe renal impairment (CrCl < 30 mL/min), as these patients were excluded from clinical trials.

Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure with these agents. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function with these agents.