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 enhancing the body’s innate ability to regulate blood sugar through the incretin system. This oral antihyperglycemic agent is designed for use as monotherapy or in combination with other glucose-lowering medications, such as metformin, sulfonylureas, or thiazolidinediones, when glycemic targets are not achieved with existing therapy alone. Its mechanism offers a targeted approach that is glucose-dependent, reducing the risk of hypoglycemia when used without sulfonylureas or insulin.

Features

• Active ingredient: Saxagliptin hydrochloride
• Available in 2.5 mg and 5 mg film-coated tablets
• Once-daily dosing regimen
• DPP-4 enzyme inhibitor class
• Not indicated for type 1 diabetes or diabetic ketoacidosis
• Can be taken with or without food

Benefits

• Enhances glycemic control by increasing active incretin hormones (GLP-1 and GIP)
• Lowers both fasting and postprandial glucose levels
• Demonstrates a low intrinsic risk of hypoglycemia when used as monotherapy or with metformin
• Provides a convenient once-daily dosing schedule that supports adherence
• May be used in combination with other antidiabetic agents for synergistic effects
• Does not cause weight gain in most clinical scenarios

Common use

Onglyza is commonly prescribed for the management of type 2 diabetes in adults whose blood sugar remains inadequately controlled through lifestyle modifications alone or with other antihyperglycemic agents. It is often utilized when metformin monotherapy proves insufficient or when a treatment with a lower hypoglycemia risk profile is desired. Clinical studies support its use in diverse patient populations, including those with renal impairment (with dose adjustment), and it is frequently incorporated into personalized treatment plans aiming for individualized HbA1c targets.

Dosage and direction

The recommended dosage of Onglyza is 5 mg taken orally once daily, with or without food. For patients with moderate to severe renal impairment (creatinine clearance ≤50 mL/min) or end-stage renal disease requiring hemodialysis, the dose should be reduced to 2.5 mg once daily. Hemodialysis may remove a small amount of saxagliptin; therefore, administration should occur following dialysis sessions. Dose adjustments are not typically required for hepatic impairment. Tablets should be swallowed whole and not crushed, split, or chewed.

Precautions

• Pancreatitis: Acute pancreatitis has been reported; discontinue promptly if suspected.
• Hypersensitivity reactions: Including anaphylaxis, angioedema, and exfoliative skin conditions.
• Hypoglycemia: Risk increases when used with sulfonylureas or insulin; may require dose reduction of these agents.
• Renal impairment: Dose adjustment necessary as described above.
• Hepatic impairment: Use with caution in patients with liver disease; monitor liver enzymes.
• Macrovascular outcomes: No clinical studies have established conclusive evidence of reduced macrovascular risk.

Contraindications

• History of serious hypersensitivity reaction to saxagliptin or any component of Onglyza
• 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
• Headache
• Nasopharyngitis

Less common but serious side effects may include:

• Acute pancreatitis
• Severe and disabling arthralgia
• Bullous pemphigoid
• Heart failure (especially when used with thiazolidinediones)
• Hypersensitivity reactions (e.g., anaphylaxis, angioedema)
• Hepatic enzyme elevations

Drug interaction

• Strong CYP3A4/5 inhibitors (e.g., ketoconazole, atazanavir, clarithromycin): May increase saxagliptin exposure; limit Onglyza dose to 2.5 mg once daily.
• Insulin secretagogues (e.g., sulfonylureas): Increased risk of hypoglycemia; consider lower dose of secretagogue.
• Insulin: May enhance hypoglycemic effect; monitor blood glucose and adjust insulin dose as needed.
• No clinically significant interactions observed with metformin, glyburide, pioglitazone, or digoxin.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If the missed dose is not remembered until the next day, the patient should skip the missed dose and resume the usual dosing schedule. Do not take a double dose to make up for a missed one.

Overdose

In the event of overdose, appropriate supportive treatment should be initiated. Saxagliptin is minimally dialyzable (removal of 23% over 4 hours). Hemodialysis is unlikely to be effective in significant overdose. There is no specific antidote for saxagliptin overdose. Close monitoring of blood glucose and symptomatic management of hypoglycemia (if present) is recommended.

Storage

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

Disclaimer

This information is intended for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of a qualified healthcare provider with any questions regarding a medical condition or treatment. Do not disregard professional medical advice or delay in seeking it because of something you have read in this document. Individual patient responses to Onglyza may vary.

Reviews

Clinical trials and post-marketing surveillance have demonstrated Onglyza’s efficacy in reducing HbA1c by approximately 0.5% to 0.8% as monotherapy and in combination regimens. It is generally well-tolerated, with a safety profile consistent across diverse populations. Some real-world evidence suggests particular utility in older adults and those with renal impairment, owing to its dosing flexibility and lower hypoglycemia risk. However, prescribers should remain vigilant regarding rare but serious adverse effects, such as pancreatitis and heart failure, and consider individual patient risk factors when initiating therapy.