Tradjenta (Linagliptin) Dosing in Renal Impairment
Primary Recommendation
No dose adjustment is required for Tradjenta (linagliptin) in patients with any degree of renal impairment, including end-stage renal disease (ESRD) or those on dialysis. 1, 2
Dosing Across All Levels of Renal Function
The standard dose of linagliptin 5 mg once daily should be maintained regardless of eGFR. 1, 2 This represents a unique advantage among DPP-4 inhibitors, as linagliptin is the only agent in this class that requires no renal dose adjustment. 1, 3
Specific Renal Function Categories:
- eGFR ≥60 mL/min/1.73 m²: 5 mg once daily 2
- eGFR 30-59 mL/min/1.73 m²: 5 mg once daily (no adjustment) 1
- eGFR 15-29 mL/min/1.73 m²: 5 mg once daily (no adjustment) 1
- eGFR <15 mL/min/1.73 m²: 5 mg once daily (no adjustment) 1, 2
- Hemodialysis or peritoneal dialysis: 5 mg once daily (no adjustment) 1, 2
Pharmacokinetic Rationale
Linagliptin undergoes primarily hepatic metabolism and biliary excretion, with negligible renal elimination. 4 This distinguishes it from other DPP-4 inhibitors:
- Sitagliptin: Requires dose reduction to 25 mg daily when eGFR <30 mL/min/1.73 m² 1
- Saxagliptin: Requires dose reduction to 2.5 mg daily when eGFR ≤45 mL/min/1.73 m² 1
- Alogliptin: Requires dose reduction to 6.25 mg daily when eGFR <30 mL/min/1.73 m² 1
Clinical pharmacokinetic data demonstrate that renal impairment has minimal effect on linagliptin exposure. 5 In a pooled analysis of 969 patients, geometric mean trough concentrations increased only modestly from 5.93 nmol/L in patients with normal renal function to 8.13 nmol/L in those with severe renal impairment—a clinically insignificant difference. 5
Clinical Trial Evidence in Renal Impairment
The CARMELINA trial included 2,200 patients (63%) with renal impairment (eGFR <60 mL/min/1.73 m²), with 15% having eGFR <30 mL/min/1.73 m². 2 The overall incidence of adverse reactions was similar between linagliptin and placebo across all renal function categories, confirming safety without dose adjustment. 2
Monitoring Requirements
No specific renal function monitoring is required for linagliptin dosing adjustments. 5 However, routine monitoring of renal function should continue as part of standard diabetes care, particularly when using concomitant medications that may affect kidney function. 1
Important Clinical Caveats
Linagliptin is not removed by hemodialysis or peritoneal dialysis, so no supplemental dosing is needed post-dialysis. 2
While no dose adjustment is required, DPP-4 inhibitors including linagliptin carry a risk of pancreatitis. 1 Discontinue if pancreatitis is suspected, though causality has not been definitively established. 1
When used with insulin or sulfonylureas, linagliptin may increase hypoglycemia risk, requiring dose reduction of these agents rather than linagliptin itself. 1