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IMPORTANT INFORMATION ABOUT ONGLYZA™ (saxagliptin)

Approved Uses

ONGLYZA™ (saxagliptin) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes mellitus.

ONGLYZA has not been studied with insulin.

ONGLYZA should not be used to treat people with type 1 diabetes or to treat diabetic ketoacidosis (dangerously high levels of certain acids, known as ketones, in the blood or urine).

Important Safety Information

When ONGLYZA is used with certain other diabetes medicines to treat high blood sugar, such as a sulfonylurea, low blood sugar (hypoglycemia) may occur. Symptoms of low blood sugar include shaking, hunger, sweating, headache, rapid heartbeat, change in mood, and change in vision. Follow your healthcare provider's instructions for treating low blood sugar.

If you have allergic (hypersensitivity) reactions, such as rash, hives, and swelling of the face, lips, and throat, stop taking ONGLYZA and call your healthcare provider right away.

When ONGLYZA is used with a thiazolidinedione (TZD), such as pioglitazone or rosiglitazone, to treat high blood sugar, peripheral edema (fluid retention) may become worse. If you have symptoms of peripheral edema, such as swelling of hands, feet, or ankles, call your healthcare provider.

The most common side effects with ONGLYZA include upper respiratory tract infection, urinary tract infection, and headache.

Your healthcare provider should test your blood to measure how well your kidneys work. You may need a lower dose of ONGLYZA if your kidneys are not working well.

Tell your healthcare provider if you start or stop taking other medications, including antibiotics, antifungals or HIV/AIDS medications, as your healthcare provider may need to change your dose of ONGLYZA.

Tell your healthcare provider if you are pregnant or breast-feeding, or plan to become pregnant or breast-feed.

Please see US Full Prescribing Information, including Patient Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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Bristol-Myers Squibb and AstraZeneca do not review the information on this Web site and/or database for content, accuracy, or completeness. Use of and access to this information is subject to the terms, limitations, and conditions set by the Web site and/or database producer.

Bristol-Myers Squibb and AstraZeneca make no representation as to the accuracy or any other aspect of the information contained on such Web site and/or database, nor does Bristol-Myers Squibb or AstraZeneca necessarily endorse such Web site and/or database.

US Full Prescribing Information Patient Information Important Safety Information Consumer Site
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IMPORTANT INFORMATION ABOUT ONGLYZA™ (saxagliptin)
Indication and Important Limitations of Use
ONGLYZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
ONGLYZA should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis.
ONGLYZA has not been studied in combination with insulin.
Important Safety Information
  • Use with Medications Known to Cause Hypoglycemia: Insulin secretagogues, such as sulfonylureas, cause hypoglycemia. Therefore, a lower dose of the insulin secretagogue may be required to reduce the risk of hypoglycemia when used in combination with ONGLYZA
  • Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with ONGLYZA or any other antidiabetic drug
Most common adverse reactions (regardless of investigator assessment of causality) reported in ≥5% of patients treated with ONGLYZA and more commonly than in patients treated with control were upper respiratory tract infection (7.7%, 7.6%), headache (7.5%, 5.2%), nasopharyngitis (6.9%, 4.0%) and urinary tract infection (6.8%, 6.1%). When used as add-on combination therapy with a thiazolidinedione, the incidence of peripheral edema for ONGLYZA 2.5 mg, 5 mg, and placebo was 3.1%, 8.1% and 4.3%, respectively.
Drug Interactions: Because ketoconazole, a strong CYP3A4/5 inhibitor, increased saxagliptin exposure, the dose of ONGLYZA should be limited to 2.5 mg when coadministered with a strong CYP3A4/5 inhibitor (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin).
Patients with Renal Impairment: The dose of ONGLYZA is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease requiring hemodialysis (creatinine clearance [CrCl] ≤50 mL/min). ONGLYZA should be administered following hemodialysis. ONGLYZA has not been studied in patients undergoing peritoneal dialysis. Assessment of renal function is recommended prior to initiation of ONGLYZA and periodically thereafter.
Pregnant and Nursing Women: There are no adequate and well-controlled studies in pregnant women. ONGLYZA, like other antidiabetic medications, should be used during pregnancy only if clearly needed. It is not known whether saxagliptin is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when ONGLYZA is administered to a nursing woman.
Pediatric Patients: Safety and effectiveness of ONGLYZA in pediatric patients have not been established.
Please see US Full Prescribing Information for Onglyza (saxagliptin).