CLINICAL PHARMACOLOGY Mechanism of Action:
Increased concentrations of the incretin hormones such as glucagon-like
peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are
released into the bloodstream from the small intestine in response to meals.
These hormones cause insulin release from the pancreatic beta cells in a
glucose-dependent manner but are inactivated by the dipeptidyl peptidase-4
(DPP4) enzyme within minutes. GLP-1 also lowers glucagon secretion from
pancreatic alpha cells, reducing hepatic glucose production. In patients with
type 2 diabetes, concentrations of GLP-1 are reduced but the insulin response to
GLP-1 is preserved. Saxagliptin is a competitive DPP4 inhibitor that slows the
inactivation of the incretin hormones, thereby increasing their bloodstream
concentrations and reducing fasting and postprandial glucose concentrations in a
glucose-dependent manner in patients with type 2 diabetes mellitus.
INDICATIONS AND USAGE Monotherapy and Combination Therapy:
ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus in multiple clinical settings.
Important Limitations of Use:
ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or
diabetic ketoacidosis, as it would not be effective in these settings.
DOSAGE AND ADMINISTRATION Recommended Dosing:
The recommended dose of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of
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. 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.
National Institutes of Health, U.S. National Library of Medicine,
DailyMed Database. Provides access to the latest drug monographs submitted to the
Food and Drug Administration (FDA). Please review the latest applicable package insert for
additional information and possible updates. A local search
option of this data can be found here.
The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical
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