GALVUS

What it is

Galvus contains the active ingredient vildagliptin. Galvus is available as a 50 mg tablet. Vildagliptin is a high affinity dipeptidyl-peptidase-4 (DPP-4) inhibitor that improves glycaemic control. The administration of vildagliptin results in rapid and near-complete inhibition of DPP-4 activity.

Approved indications

Galvus is indicated for the treatment of type 2 diabetes mellitus in persons 18 years of age and older, as an adjunct to diet and exercise to improve glycaemic control: — 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.

Dosing overview

Doses greater than 100 mg are not recommended. The 50 mg dose should be administered once daily in the morning. The 100 mg daily dose should be administered as two divided doses of 50 mg taken in the morning and evening. As monotherapy the recommended dose of Galvus is 50 mg twice daily (100 mg daily dose). In dual combination therapy with metformin or a thiazolidinedione, the recommended dose of vildagliptin is 50 mg once daily or 100 mg daily. When used in dual combination with a sulfonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning. In combination with insulin the recommended dose is 50 mg once daily or 100 mg daily. In triple combination therapy with metformin and a sulfonylurea the recommended dose is 100 mg daily. No dosage adjustment of vildagliptin is required in patients with mild chronic kidney disease. In patients with moderate or severe renal impairment or End Stage Renal Disease, the recommended dose of vildagliptin is 50 mg once daily.

Key safety warnings

Use of vildagliptin has been associated with a risk of developing acute pancreatitis. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted. Rare cases of hepatic dysfunction (including hepatitis) have been reported. In these cases, the patients were generally asymptomatic without clinical sequelae and liver function tests returned to normal after discontinuation of treatment. Liver function tests should be performed prior to the initiation of treatment with vildagliptin. Liver function tests should be monitored during vildagliptin treatment at three-month intervals during the first year and periodically thereafter. There have been post-marketing reports of joint pain, which may be severe, in patients taking DPP-4 inhibitors. Onset of symptoms following initiation of treatment may be rapid or may occur after longer periods. Discontinuation of therapy should be considered in patients who present with or experience an exacerbation of joint symptoms during treatment with DPP-4 inhibitors. Post-marketing cases of bullous pemphigoid requiring hospitalisation have been reported with DPP-4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. If bullous pemphigoid is suspected, Galvus should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.

Contraindications

Hypersensitivity to vildagliptin or to any of the excipients.

PBS listing

Galvus 50 mg tablets are listed on the PBS with 2 items, streamlined restriction, at an ex-manufacturer price of A$25.52.

Regulatory history

Galvus vildagliptin 50 mg tablets were first listed on the ARTG on 2 March 2010. In March 2016, the PBAC recommended PBS listing of vildagliptin in triple oral combination with metformin and a sulfonylurea on a cost-minimisation basis with dapagliflozin. In November 2017, the PBAC recommended a streamlined Authority Required listing of vildagliptin and vildagliptin with metformin fixed-dose combination for use in combination with insulin.