From the Guidelines
The recommended dose of Januvia (sitagliptin) for patients with impaired renal function is a maximum of 50 mg daily for those with an eGFR of 30-44 mL/min/1.73 m2 and a maximum of 25 mg once daily for those with an eGFR of 15-29 mL/min/1.73 m2. When considering the management of diabetes in patients with chronic kidney disease, it's crucial to adjust the dosage of medications like Januvia according to the patient's renal function to minimize potential side effects and maximize efficacy [ 1 ]. Key considerations include:
- For patients with Stage 3b chronic kidney disease (eGFR 30–44 mL/min/1.73 m2), the dose should not exceed 50 mg daily.
- For those with Stage 4 chronic kidney disease (eGFR 15–29 mL/min/1.73 m2), the dose should be limited to 25 mg once daily. These recommendations are based on the consensus report by the American Diabetes Association (ADA) and Kidney Disease: Improving Global Outcomes (KDIGO) [ 1 ], emphasizing the importance of tailored diabetes management in the context of renal impairment to optimize patient outcomes.
From the FDA Drug Label
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food. 2.2 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of JANUVIA and periodically thereafter. For patients with an estimated glomerular filtration rate [eGFR] greater than or equal to 45 mL/min/1. 73 m2 to less than 90 mL/min/1.73 m2, no dosage adjustment for JANUVIA is required. For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m2 to less than 45 mL/min/1.73 m2), the dose of JANUVIA is 50 mg once daily. For patients with severe renal impairment (eGFR less than 30 mL/min/1. 73 m2) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. The recommended dose of Januvia (sitagliptin) for patients with impaired renal function is as follows:
- No dosage adjustment is required for patients with an eGFR ≥ 45 mL/min/1.73 m2.
- 50 mg once daily for patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2 to < 45 mL/min/1.73 m2).
- 25 mg once daily for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis 2.
From the Research
Januvia Doses for Patients with Impaired Renal Function
The recommended dose of Januvia (sitagliptin) for patients with impaired renal function is as follows:
- For patients with moderate renal insufficiency (creatinine clearance ≥30 to <50 mL/min), the recommended dose is 50 mg once daily 3
- For patients with severe renal insufficiency (creatinine clearance <30 mL/min), the recommended dose is 25 mg once daily 3
- For patients with end-stage renal disease (ESRD) on dialysis, the recommended dose is 25 mg once daily 3
Key Considerations
- Sitagliptin is primarily eliminated by the kidney, and a reduced dose is recommended for patients with chronic kidney disease (CKD) 4
- The risk of congestive heart failure was not higher in older adults with CKD starting sitagliptin at >50 versus ≤50 mg/d 4
- Patients with moderate or severe renal impairment had a lower incidence of hypoglycemia with sitagliptin compared to sulfonylurea 5
- Sitagliptin was generally well tolerated and provided effective glycemic control in patients with type 2 diabetes and moderate to severe renal insufficiency, including patients with ESRD on dialysis 3