Generic name: saxagliptin
Dosage form: tablet, film coated
This dosage information does not include all the information needed to use Onglyza safely and effectively. See full prescribing information for Onglyza.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
The recommended dose of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals.
â€‹ONGLYZA tablets must not be split or cut.
Patients with Renal Impairment
No dosage adjustment for ONGLYZA is recommended for patients with mild renal impairment (creatinine clearance [CrCl] >50 mL/min).
The dose of ONGLYZA is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min) [see Clinical Pharmacology (12.3) and Clinical Studies (14.3)]. ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis.
Because the dose 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. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula. [See Clinical Pharmacology (12.3).]
Strong CYP3A4/5 Inhibitors
The dose 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 Drug Interactions (7.1) and Clinical Pharmacology (12.3).]
â€‹2.4 Concomitant Use with an Insulin Secretagogue (e.g., Sulfonylurea) or with Insulin
â€‹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 Warnings and Precautions (5.1).]