Pediatric Use: Safety and effectiveness of Alogliptin in pediatric patients have not been established.
Geriatric Use: Of the total number of patients (N=8507) in clinical safety and efficacy studies treated with Alogliptin, 2064 (24.3%) patients were 65 years and older and 341 (4%) patients were 75 years and older. No overall differences in safety or effectiveness were observed between patients 65 years and over and younger patients. While this clinical experience has not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out.
Hepatic Impairment: No dose adjustments are required in patients with mild to moderate hepatic impairment (Child-Pugh Grade A and B) based on insignificant change in systemic exposures (e.g., AUC) compared to subjects with normal hepatic function in a pharmacokinetic study. Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh Grade C). Use caution when administering Alogliptin to patients with liver disease.
Patients with Renal Impairment:
- No dose adjustment of Alogliptin is necessary for patients with mild renal impairment (creatinine clearance ≥60 mL/min).
- The dose of Alogliptin is 12.5 mg once daily for patients with moderate renal impairment (creatinine clearance ≥30 to <60 mL/min).
- The dose of Alogliptin is 6.25 mg once daily for patients with severe renal impairment (creatinine clearance ≥15 to <30 mL/min) or with end-stage renal disease (ESRD) (creatinine clearance <15 mL/min or requiring hemodialysis).
- Patients requiring hemodialysis can receive their dose of alogliptin without regard to the timing of the dialysis.
