Januvia no longer contraindicated in renal impairment

Clinical study

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.

Dosage recommendations

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.

View Januvia drug record

View Janumet drug record

Further information: Merck Sharp & Dohme Ltd