July 29, 2016
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Onglyza

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Onglyza




Indications
Dosage
How Supplied

INDICATIONS

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 [see Clinical Studies].

Limitation Of Use

ONGLYZA is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

DOSAGE AND ADMINISTRATION

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 mild renal impairment (creatinine clearance [CrCl] > 50 mL/min).

The dosage of ONGLYZA is 2.5 mg once daily (regardless of meals) 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 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. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula [see CLINICAL PHARMACOLOGY].

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 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].

HOW SUPPLIED

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 15.

Table 15: 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 0310-6105-30
Bottles of 90 0310-6105-90
Bottles of 500 0310-6105-50
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 0310-6100-30
Bottles of 90 0310-6100-90

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].

Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. For more information, go to www.ONGLYZA.com or call 1-800-ONGLYZA. Revised: Apr 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/19/2016

Indications
Dosage
How Supplied

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