Recommended Dosing: 100 mg once daily as mono- or in combination therapy with metformin or a PPARγ agonist (eg, thiazolidinediones). Januvia can be taken with or without food.
Patients with Renal Insufficiency: For patients with mild renal insufficiency [creatinine clearance (CrCl) ≥50 mL/min, approximately corresponding to serum creatinine levels of ≤1.7 mg/dL in men and ≤1.5 mg/dL in women], no dosage adjustment for Januvia is required.
For patients with moderate renal insufficiency (CrCl ≥30 to <50 mL/min, approximately corresponding to serum creatinine levels of >1.7 to ≤3 mg/dL in men and >1.5 to ≤2.5 mg/dL in women), the dose of Januvia is 50 mg once daily.
For patients with severe renal insufficiency (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3 mg/dL in men and >2.5 mg/dL in women) or with endstage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Januvia is 25 mg once daily. Januvia may be administered without regard to the timing of hemodialysis.
Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Januvia and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula. (See Pharmacology and Pharmacokinetics under Actions.)