In an open-label study, the pharmacokinetics of Januvia (sitagliptin) were assessed in patients with differing degrees of renal impairment and those with end-stage renal disease on haemodialysis (ESRD). Patients were administered a reduced single dose of 50mg sitagliptin.
A clinically significant increase in plasma concentration of sitagliptin was not observed in patients with mild renal impairment in comparison with normal healthy patients. In contrast, an approximate 2-fold increase in plasma AUC of sitagliptin was seen in patients with moderate renal impairment and an approximate 4-fold increase was observed in patients with severe renal impairment and patients with ESRD on haemodialysis.
No dose adjustment is required in patients with mild renal insufficiency (CrCl ≥50ml/min). For patients with moderate renal impairment (CrCl 30 to 50ml/min), the dose of Januvia is 50mg once daily. In patients with severe renal impairment (CrCl <30ml/min) or end-stage renal disease requiring dialysis, the dose of Januvia is 25mg once daily.
Renal function should be assessed before starting and measured periodically thereafter.
Recommendations do not apply to Janumet
The combination product Janumet (sitagliptin + metformin) is still contraindicated in patients with moderate to severe renal impairment owing to the metformin component.
Updated 27 April 2012
New strengths of Januvia available
Januvia is now available as 25mg and 50mg tablets to facilitate dosing in moderate to severe renal impairment.