Trelagliptin Maximum Dose Per Day
The maximum recommended daily dose of trelagliptin is 100 mg once weekly (not daily), as this is a once-weekly DPP-4 inhibitor, not a daily medication. 1, 2, 3, 4, 5
Standard Dosing
- Standard dose: Trelagliptin 100 mg administered orally once per week for patients with normal renal function 1, 3, 4, 5
- Administration: Can be taken at any time of day, with or without food 4, 5
- Monotherapy or combination: The 100 mg weekly dose applies whether used as monotherapy or in combination with other antidiabetic agents including metformin, sulfonylureas, glinides, α-glucosidase inhibitors, biguanides, thiazolidinediones, or insulin 3, 4
Dose Adjustments in Renal Impairment
Severe renal impairment or end-stage renal disease:
- Reduced dose: 25 mg once weekly for patients with creatinine clearance <30 mL/min or those on hemodialysis 2
- This represents a 75% dose reduction from the standard 100 mg weekly dose 2
- The 25 mg weekly dose demonstrated significant HbA1c reduction of -0.71% compared to placebo in patients with severe renal impairment or end-stage renal disease 2
Moderate renal impairment:
- Modeling studies suggest dose reduction by half (50 mg weekly) may be appropriate in patients with severe renal impairment, though clinical recommendations support the 25 mg weekly dose 6
Important Clarification
The FDA drug label references 7 in the evidence provided are incorrect and refer to triprolidine (an antihistamine), not trelagliptin. This appears to be a database error. The correct dosing information comes from the clinical trial data 1, 2, 3, 4, 5.
Safety Profile
- Well-tolerated: Treatment-emergent adverse events were comparable to placebo and other DPP-4 inhibitors, with most being mild-to-moderate 2, 4, 5, 8
- Hypoglycemia risk: No severe hypoglycemia was reported when trelagliptin was used with insulin, making it a safer option than sulfonylureas 3
- Long-term safety: 52-week studies demonstrated sustained safety across all combination therapies 4