Onglyza (saxagliptin) is a prescription medication indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. As a dipeptidyl peptidase-4 (DPP-4) inhibitor, it functions by increasing the levels of active incretin hormones, which stimulate insulin release in a glucose-dependent manner and decrease glucagon secretion. This mechanism offers a targeted approach to lowering blood glucose with a favorable tolerability profile. It may be used as monotherapy or in combination with other antihyperglycemic agents, such as metformin, sulfonylureas, or thiazolidinediones, providing flexibility in treatment regimens tailored to individual patient needs.

Features

• Active ingredient: Saxagliptin
• Pharmacologic class: Dipeptidyl peptidase-4 (DPP-4) inhibitor
• Available in 2.5 mg and 5 mg oral tablets
• Once-daily dosing regimen
• Not associated with weight gain in clinical trials
• Renal dosing adjustments available for impaired kidney function

Benefits

• Enhances glucose-dependent insulin secretion for improved glycemic control without increasing hypoglycemia risk when used alone
• Reduces hemoglobin A1c (HbA1c) levels effectively as part of a comprehensive diabetes management plan
• Provides a weight-neutral treatment option, supporting metabolic goals without contributing to weight gain
• Offers convenient once-daily dosing to support adherence and simplify treatment regimens
• Compatible with other common antidiabetic therapies, allowing for individualized combination treatment strategies
• Demonstrates a generally favorable cardiovascular safety profile in post-marketing studies

Common use

Onglyza is commonly prescribed for the management of type 2 diabetes mellitus in adult patients. It is frequently utilized when glycemic control remains inadequate despite lifestyle modifications and first-line pharmacotherapy, particularly metformin. Clinicians may initiate saxagliptin as add-on therapy to metformin, a sulfonylurea, or a thiazolidinedione when additional glycemic lowering is required without introducing significant hypoglycemia risk or weight gain concerns. It is also appropriate for use in patients who may not tolerate metformin or other first-line agents due to gastrointestinal side effects or contraindications. The medication is often selected for its neutral effect on weight and low risk of hypoglycemia when not combined with insulin secretagogues.

Dosage and direction

The recommended dosage of Onglyza is 5 mg administered once daily, regardless of meals. For patients with moderate or severe renal impairment (creatinine clearance ≤50 mL/min) or with end-stage renal disease requiring hemodialysis, the recommended dosage is 2.5 mg once daily. No dosage adjustment is required for patients with mild renal impairment (creatinine clearance >50 mL/min). The tablet should be swallowed whole with water and may be taken at any time of day, though consistency in timing is recommended to maintain stable drug levels. When used in combination with a sulfonylurea or insulin, a lower dose of the sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

Precautions

Patients should be advised that Onglyza is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Use with caution in patients with a history of pancreatitis, as postmarketing reports have described acute pancreatitis; discontinue promptly if pancreatitis is suspected. Monitor renal function periodically, as dosage adjustment is necessary in renal impairment. There have been postmarketing reports of severe and disabling arthralgia; consider discontinuation if severe joint pain occurs. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Breastfeeding is not recommended during treatment. Hypersensitivity reactions such as urticaria, angioedema, or anaphylaxis have been reported; discontinue if suspected.

Contraindications

Onglyza is contraindicated in patients with a history of serious hypersensitivity reaction to saxagliptin or any component of the formulation, including anaphylaxis, angioedema, or severe cutaneous adverse reactions. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Possible side effect

Common adverse reactions (≥5%) include upper respiratory tract infection, urinary tract infection, and headache. Hypoglycemia may occur when used in combination with sulfonylureas or insulin. Less common but potentially serious side effects include pancreatitis (manifested as persistent severe abdominal pain), hypersensitivity reactions (including anaphylaxis, angioedema, and exfoliative skin conditions), severe joint pain, and heart failure (particularly in patients with pre-existing cardiovascular disease). Elevated liver enzymes have been observed; monitor liver function periodically. Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Onglyza or any other antidiabetic drug.

Drug interaction

Strong CYP3A4/5 inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin) may increase saxagliptin exposure; limit Onglyza dosage to 2.5 mg once daily when coadministered. No clinically significant interactions have been observed with metformin, glyburide, pioglitazone, digoxin, simvastatin, or diltiazem. When used with insulin secretagogues (e.g., sulfonylureas) or insulin, the risk of hypoglycemia may be increased; consider lowering the dose of the secretagogue or insulin.

Missed dose

If a dose of Onglyza is missed, it should be taken as soon as remembered on the same day. However, if remembered at the time of the next scheduled dose, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed dose.

Overdose

In the event of overdose, appropriate supportive treatment should be initiated according to the patient’s clinical presentation. Hemodialysis removed approximately 23% of the saxagliptin dose over a 4-hour session; however, the clinical utility of this information in overdose management is uncertain. There is no specific antidote for saxagliptin overdose. Contact a poison control center for current recommendations on management.

Storage

Store Onglyza tablets at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container with the lid tightly closed to protect from moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the bottle.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Onglyza is available by prescription only and should be used under the supervision of a qualified healthcare professional. Patients should not initiate, discontinue, or change dosage without consulting their physician. Individual results may vary, and only a healthcare provider can determine if this medication is appropriate based on a patient’s specific medical condition, history, and current medications.

Reviews

Clinical trials have demonstrated that Onglyza effectively reduces HbA1c by approximately 0.4-0.8% when used as monotherapy and provides additional glycemic control when combined with other antidiabetic agents. The drug is generally well-tolerated, with low incidence of gastrointestinal side effects compared to some other antidiabetic medications. Many clinicians appreciate its weight-neutral profile and once-daily dosing convenience, which may improve adherence. Some post-marketing studies have raised questions about potential increased risk of heart failure hospitalization, particularly in patients with existing cardiovascular disease, though the absolute risk remains low. Overall, Onglyza represents a valuable option in the type 2 diabetes treatment arsenal, particularly for patients who require additional glycemic control without weight gain or significant hypoglycemia risk.