Vildagliptin STELLA 50 mg

Rx

Indications

Treatment of type 2 diabetes mellitus in adults:

• As monotherapy in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance.
• As dual oral therapy in combination with:
  – metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin.
  – a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance.
  – a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.
• As triple oral therapy in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• In combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.

Dosage

Adults

• When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a sulphonylurea, or in combination with insulin (with or without metformin):
  Daily dose: Vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
• When used in dual combination with a sulphonylurea:
  Vildagliptin is 50 mg once daily administered in the morning.
  When used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
• Doses higher than 100 mg are not recommended.
• If a dose of vildagliptin is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
• The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.

Elderly (≥ 65 years)

• No dose adjustments are necessary.

Renal impairment

• No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/min). In patients with moderate or severe renal impairment or with end-stage renal disease (ESRD), the recommended dose of vildagliptin is 50 mg once daily.

Hepatic impairment

• Vildagliptin should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN).

Paediatric population

• Vildagliptin is not recommended for use in children and adolescents.

Usage

• Vildagliptin STELLA 50 mg can be administered with or without a meal.

• Hypersensitivity to vildagliptin or to any of the excipients.

Common

• Monotherapy
  Dizziness.
• Combination with metformin
  Hypoglycaemia,
  Tremor, headache, dizziness,
  Nausea.
• Combination with a sulphonylurea
  Hypoglycaemia,
  Tremor, headache, dizziness, asthenia.
• Combination with a thiazolidinedione:
  Weight increase,
  Oedema peripheral.
• Combination with metformin and a sulphonylurea
  Hypoglycaemia,
  Dizziness, tremor,
  Hyperhidrosis,
  Asthenia.
• Combination with insulin
  Decreased blood glucose,
  Headache, chills,
  Nausea, gastro-oesophageal reflux disease.

• 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.
• Vildagliptin should be used with caution in patients with ESRD on haemodialysis.
• Liver function tests should be performed prior to the initiation of treatment with vildagliptin in order to know the patient’s baseline value. Liver function should be monitored during treatment with vildagliptin at three-month intervals during the first year and periodically thereafter. Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent liver function tests until the abnormality(ies) return(s) to normal. Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of vildagliptin therapy is recommended. Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue vildagliptin. Following withdrawal of treatment with vildagliptin and LFT normalisation, treatment with vildagliptin should not be reinitiated.
• Patients with NYHA functional class IV is not recommended using vildagliptin.
• In keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
• Use of vildagliptin has been associated with a risk of developing acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis. If pancreatitis is suspected, vildagliptin should be discontinued; if acute pancreatitis is confirmed, vildagliptin should not be restarted. Caution should be exercised in patients with a history of acute pancreatitis.
• Patients receiving vildagliptin in combination with a sulphonylurea may be at risk for hypoglycaemia. Therefore, a lower dose of sulphonylurea may be considered to reduce the risk of hypoglycaemia.
• Vildagliptin STELLA 50 mg contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Vildagliptin should not be used during pregnancy and breast-feeding.
• No studies on the effects on the ability to drive and use machines have been performed. Patients who experience dizziness as an adverse reaction should avoid driving vehicles or using machines.