Recommended Dosage: The recommended dosage of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals.
ONGLYZA tablets must not be split or cut.
Dosage in Patients with Renal Impairment: No dosage adjustment for ONGLYZA is recommended for patients with eGFR ≥45 mL/min/1.73 m2).
TThe dosage of ONGLYZA is 2.5 mg once daily (regardless of meals) for patients with eGFR <45 mL/min/1.73 m2 (which includes a subset of moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis) [see Pharmacology and Pharmacodynamics: Clinical Studies under Actions]. ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis.
Because the dosage of ONGLYZA should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter.
Dosage Adjustment with Concomitant Use of Strong CYP3A4/5 Inhibitors: The dosage of ONGLYZA is 2.5 mg once daily when coadministered with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin). [See Interactions and Pharmacology under Actions].
Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin: When ONGLYZA is used in combination with an insulin secretagogue (e.g., sulfonylurea) or with insulin, a lower dose of the insulin secretagogue or insulin may be required to minimize the risk of hypoglycemia. [See Precautions].