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Galvus
Generic Name: Vildagliptin
Drug Category: DPP-4 Inhibitor
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 2 years.
| Approved Uses |
|
Treatment of diabetes mellitus type 2 in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes: • As monotherapy, in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance. • In dual combination with one of metformin, a sulfonylurea or pioglitazone when diet, exercise and the single agent do not result in adequate glycaemic control. • In triple combination with a sulfonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control. • In combination with insulin (with or without metformin) when diet, exercise and a stable dose of insulin do not result in adequate glycaemic control. –Vildagliptin is not a substitute for insulin in insulin-requiring patients. Vildagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. –The use of vildagliptin is not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST > 2.5x the upper limit of normal (ULN). –Use of vildagliptin has been associated with a risk of developing acute pancreatitis. Patients should be informed of the characteristic symptoms of acute pancreatitis. –Vildagliptin should not be used during pregnancy unless the benefit to the mother outweighs the potential risk to the foetus. Attainment of strict normoglycaemia during pregnancy may require conversion to insulin monotherapy. |
| Off-label Uses |
|
• Use in patients under the age of 18. GoToSource • Type 1 diabetes and treatment of diabetic ketoacidosis. GoToSource • Cognitive deficits in alzheimer’s disease. GoToSource • Improve renal function by decreasing albuminuria. GoToSource • New-onset diabetes after transplantation. GoToSource • Chronic foot ulcers. GoToSource |
| Adverse Events |
|
Hypoglycemia and increased transaminase levels. GoToSource Acute pancreatitis. GoToSource Bullous pemphigoid (skin lesions). GoToSource Increased clinical heart failure and worsened outcomes in patients with existing heart failure. GoToSource Polyarthritis (arthritis involving 5 or more joints). GoToSource Angioedema (rapid swelling). GoToSource |
| Litigation |
|
No major injury lawsuits reported. |
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