Xelevia Dosage/Direction for Use

The recommended dose of SITAGLIPTIN (XELEVIA) is 100 mg once daily as monotherapy or as combination therapy with metformin, a sulfonylurea, insulin (with or without metformin), a PPARγ agonist (e.g., thiazolidinediones), metformin plus a sulfonylurea, or metformin plus a PPARγ agonist.
When SITAGLIPTIN (XELEVIA) is used in combination with a sulfonylurea or with insulin, a lower dose of sulfonylurea or insulin may be considered to reduce the risk of sulfonylurea- or insulin-induced hypoglycemia. (See Hypoglycemia in Combination with a Sulfonylurea or with Insulin under Precautions.)
Patients with Renal Impairment: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of SITAGLIPTIN (XELEVIA) and periodically thereafter.
For patients with mild renal impairment (estimated glomerular filtration rate [eGFR] ≥ 60 mL/min/1.73 m² to < 90 mL/min/1.73 m²), no dosage adjustment for SITAGLIPTIN (XELEVIA) is required.
For patients with moderate renal impairment (eGFR ≥ 45 mL/min/1.73 m² to < 60 mL/min/1.73 m²), no dosage adjustment for SITAGLIPTIN (XELEVIA) is required.
For patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m² to <45 mL/min/1.73 m²), the dose of SITAGLIPTIN (XELEVIA) is 50 mg once daily.
For patients with severe renal impairment (eGFR ≥ 15 mL/min/1.73 m² to < 30 mL/min/1.73 m²) or with end-stage renal disease (ESRD) (eGFR < 15 mL/min/1.73 m²), including those requiring hemodialysis or peritoneal dialysis, the dose of SITAGLIPTIN (XELEVIA) is 25 mg once daily. SITAGLIPTIN (XELEVIA) may be administered without regard to the timing of dialysis.
Mode of Administration: SITAGLIPTIN (XELEVIA) can be taken orally with or without food.