Onglyza: Advanced DPP-4 Inhibitor for Type 2 Diabetes Management
Onglyza
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Onglyza (saxagliptin) is a selective dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It functions by enhancing the body’s own ability to lower elevated blood glucose levels through the incretin system. Clinical studies demonstrate its efficacy in reducing HbA1c, either as monotherapy or in combination with other antidiabetic agents. Onglyza offers a mechanism of action that is glucose-dependent, thereby minimizing 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 oral administration, with or without food
- DPP-4 enzyme inhibition increases active incretin hormones (GLP-1 and GIP)
- Enhances glucose-dependent insulin secretion from pancreatic beta cells
- Suppresses glucagon secretion from pancreatic alpha cells
- Manufactured under current Good Manufacturing Practices (cGMP)
- Shelf-stable formulation without requirement for refrigeration
Benefits
- Significant reduction in HbA1c levels, with mean decreases of 0.4% to 0.9% in clinical trials
- Low inherent risk of hypoglycemia when used as monotherapy
- Weight-neutral profile, unlike some other antidiabetic medications
- Convenient once-daily dosing supports medication adherence
- Can be used in combination with metformin, sulfonylureas, thiazolidinediones, or insulin
- Suitable for patients with renal impairment (dose adjustment required)
Common use
Onglyza is primarily prescribed for the management of type 2 diabetes mellitus in adults. It is commonly used when glycemic control is not adequately achieved through lifestyle modifications alone. Physicians often initiate Onglyza therapy when metformin monotherapy proves insufficient or when metformin is contraindicated. The medication may be utilized as part of a comprehensive diabetes management plan that includes dietary modifications, physical activity, and regular blood glucose monitoring. It is particularly valuable for patients who require glycemic control without the weight gain associated with some other antidiabetic agents.
Dosage and direction
The recommended dosage of Onglyza is 5 mg once daily, administered orally 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 recommended dosage is 2.5 mg once daily. No dosage adjustment is required for patients with hepatic impairment. Tablets should be swallowed whole and not crushed, chewed, or split. Healthcare providers should assess renal function before initiating therapy and periodically thereafter. Onglyza may be taken at any time of day, though consistency in dosing time is recommended to maintain stable drug levels.
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 included acute pancreatitis. Monitor for signs and symptoms of pancreatitis during treatment. There have been reports of hypersensitivity reactions, including anaphylaxis, angioedema, and exfoliative skin conditions. Discontinue immediately if hypersensitivity occurs. Use with caution in patients taking strong CYP3A4/5 inhibitors (e.g., ketoconazole, atazanavir, clarithromycin), as these may increase saxagliptin exposure. Periodic monitoring of renal function is recommended. Not recommended during pregnancy unless potential benefit justifies potential risk to the fetus.
Contraindications
Onglyza is contraindicated in patients with a history of serious hypersensitivity reaction to saxagliptin or any component of the formulation. This includes reactions such as anaphylaxis, angioedema, or severe cutaneous adverse reactions. The medication is not recommended for use in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Concurrent use with alogliptin, linagliptin, sitagliptin, or other DPP-4 inhibitors is contraindicated due to therapeutic duplication.
Possible side effects
The most common adverse reactions (≥5%) reported in clinical trials include upper respiratory tract infection, urinary tract infection, and headache. Hypoglycemia was more common when Onglyza was used in combination with sulfonylurea or insulin. Other reported side effects include peripheral edema (when used with thiazolidinediones), sinusitis, nasopharyngitis, vomiting, and rash. Less common but serious adverse reactions include acute pancreatitis (postmarketing reports), severe joint pain, bullous pemphigoid, and heart failure (observed in a clinical trial of patients with cardiovascular disease). Patients should report any unusual symptoms to their healthcare provider promptly.
Drug interaction
Strong CYP3A4/5 inhibitors (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin) may increase saxagliptin concentrations. Consider reducing the Onglyza dose to 2.5 mg daily when coadministered with strong CYP3A4/5 inhibitors. Moderate CYP3A inhibitors (e.g., diltiazem, erythromycin, fluconazole, verapamil) may also increase saxagliptin exposure. No clinically significant interactions have been observed with metformin, glyburide, pioglitazone, digoxin, simvastatin, or diltiazem. However, medications that affect renal function may alter saxagliptin clearance.
Missed dose
If a dose of Onglyza is missed, the patient should take it as soon as they remember, unless it is almost time for the next scheduled dose. In that case, 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 one. Consistent daily administration is important for maintaining glycemic control, so healthcare providers should counsel patients on strategies to improve adherence if missed doses become frequent.
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, suggesting that hemodialysis may be effective in cases of significant overdose. There is no specific antidote for saxagliptin overdose. Reported doses of up to 400 mg daily for two weeks were not associated with significant clinical adverse reactions in healthy volunteers, though hypoglycemia could occur, particularly when Onglyza is administered with other antidiabetic medications.
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 container with the lid tightly closed to protect from moisture. Do not store in bathroom cabinets or other humid areas. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Properly dispose of any unused or expired medication according to local regulations.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Healthcare professionals should refer to the full prescribing information before initiating therapy. Patients should not make changes to their medication regimen without consulting their healthcare provider. The efficacy and safety of Onglyza may vary among individuals, and treatment decisions should be based on individual patient characteristics and professional medical judgment.
Reviews
Clinical trials have demonstrated Onglyza’s efficacy in glycemic control across diverse patient populations. In a 24-week study, saxagliptin 5 mg daily produced statistically significant reductions in HbA1c compared to placebo. Combination therapy studies showed additive effects when used with metformin, sulfonylureas, or thiazolidinediones. The SAVOR-TIMI 53 cardiovascular outcomes trial included over 16,000 patients and found saxagliza met non-inferiority for cardiovascular safety compared to placebo, though there was an increased rate of hospitalization for heart failure in the saxagliptin group. Real-world evidence supports the maintenance of glycemic control with generally favorable tolerability in clinical practice.