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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. [See Clinical Studies.]
Important Limitations of Use
ONGLYZA has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using ONGLYZA. [See WARNINGS AND PRECAUTIONS]
DOSAGE AND ADMINISTRATION
The recommended dose of ONGLYZA is 2.5 mg or 5 mg once daily taken regardless of meals.
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 and Clinical Studies]. 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.]
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 and CLINICAL PHARMACOLOGY.]
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 WARNINGS AND PRECAUTIONS]
Dosage Forms and Strengths
- ONGLYZA (saxagliptin) 5 mg tablets are pink, biconvex, round, film-coated tablets with "5" printed on one side and "4215" printed on the reverse side, in blue ink.
- ONGLYZA (saxagliptin) 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets with "2.5" printed on one side and "4214" printed on the reverse side, in blue ink.
ONGLYZA® (saxagliptin) tablets have markings on both sides and are available in the strengths and packages listed in Table 13.
Table 13: ONGLYZA Tablet Presentations
|Tablet Strength||Film-Coated Tablet Color/Shape||Tablet Markings||Package Size||NDC Code|
|5 mg||pink biconvex, round||"5" on one side and "4215" on the reverse, in blue ink||Bottles of 30||0003-4215-11|
|Bottles of 90||0003-4215-21|
|Bottles of 500||0003-4215-31|
|Blister of 100||0003-4215-41|
|2.5 mg||pale yellow to light yellow biconvex, round||"2.5" on one side and "4214" on the reverse, in blue ink||Bottles of 30||0003-4214-11|
|Bottles of 90||0003-4214-21|
Storage and Handling
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Manufactured by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Marketed by: Bristol-Myers Squibb Company Princeton, NJ 08543 and AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Rev December 2011
Last reviewed on RxList: 1/6/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Onglyza Information
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