Galvus

Galvus

vildagliptin

Manufacturer:

Novartis Indonesia
Full Prescribing Info
Contents
Vildagliptin.
Indications/Uses
Galvus is indicated as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus (T2DM): as monotherapy.
In dual combination with metformin, a sulphonylurea (SU), a thiazolidinedione (TZD) when diet, exercise and a single antidiabetic agent do not result in adequate glycaemic control.
In triple combination: In patients with uncontrolled use of sulphonylurea (at submaximal dose) and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
It is not recommended as initial therapy.
Galvus is also indicated for use in combination with insulin (with or without metformin), when maximal tolerated dose of insulin (without metformin or with maximal tolerated dose of metformin) as an adjunct to diet and exercise do not provide adequate glycemic control.
Dosage/Direction for Use
The management of antidiabetic therapy should be individualized.
Monotherapy: The recommended dose of Galvus is 50 mg or 100 mg daily. The 50 mg dose should be administered once daily in the morning. The 100 mg dose should be administered as two divided doses of 50 mg given in the morning and evening.
Combination therapy: Combination therapy with other antidiabetic drugs such metformin, an SU, a TZD or insulin may be given if a tighter glycaemic control is required on the top of the maximum recommended daily dose of 100 mg Galvus monotherapy.
The recommended dose of Galvus is 50 mg or 100 mg daily in dual combination with metformin, or a TZD or insulin. The 50 mg dose should be administered once daily in the morning. The 100 mg dose should be administered as two divided dose of 50 mg given in the morning and evening.
The recommended dose of Galvus is 50 mg bid for triple combination with metformin and a SU.
When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning. In this patient population, vildagliptin 100 mg daily was no more effective than vildagliptin 50 mg once daily.
Special populations: Hepatic impairment: Galvus 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).
No dosage adjustment of Galvus is required in patients with mild renal impairment. In patients with moderate or severe renal impairment, the recommended dose of Galvus is 50 mg once daily.
Renal impairment: Galvus is, however, not recommended in patients with End Stage Renal Disease (ESRD) on haemodialysis due to limited experience in patients with End Stage Renal Disease (ESRD) on haemodialysis (see also Precautions).
There is limited data on the use of combination therapy in patients with renal and hepatic impairment. Therefore, the use of Galvus in combination therapy is not recommended in these patients.
Geriatrics: In patients treated with Galvus ≥65 years of age and ≥75 years of age, no differences were observed in the overall safety, tolerability, or efficacy between this elderly population and younger patients. No dosage adjustments are therefore necessary in the elderly patients.
Paediatric patients: Galvus has not been studied in patients under 18 years of age; therefore, the use of Galvus in paediatric patients is not recommended.
Method of administration: For oral use.
Galvus can be administered with or without meal.
If a dose of Galvus is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
Contraindications
Hypersensitivity to vildagliptin or to any of the excipients.
Special Precautions
Galvus should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Not recommended in patients with End Stage Renal Disease (ESRD) on haemodialysis. Not recommended in patients with hepatic impairment including patients with a pre-treatment ALT or AST>2.5X the upper limit of normal. Liver function tests (LFT) to be performed prior to treatment initiation, at three-month intervals during the first year and periodically thereafter. Withdrawal of therapy with Galvus recommended if an increase in AST or ALT of 3X the upper limit normal or greater persist. Following withdrawal of treatment with Galvus and LFT normalization, treatment with Galvus should not be reinitiated. Clinical experience in patients with NYHA functional class III treated with vildagliptin is still limited and results are inconclusive. Not recommended in patients with NYHA Class IV. Contains lactose.
Special excipient: Contains lactose.
Use in pregnancy: Not to be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Use in lactation: Not to be used.
Use In Pregnancy & Lactation
Women of child-bearing potential, pregnancy: Not to be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.
Breast-feeding: Not to be used.
Adverse Reactions
Rare cases of angioedema. Rare cases of hepatic dysfunction (including hepatitis). Monotherapy - Common: dizziness, nasopharyngitis, hypertension. Uncommon: headache, constipation, nausea, diarrhea, edema peripheral. Combination with metformin - Common: tremor, dizziness, headache. Combination with a sulfonylurea - Common: tremor, headache, dizziness, asthenia. Combination with a thiazolidinedione - Common: weight increase, edema peripheral. Combination with insulin - Common: headache, nausea, gastrooesophageal reflux disease, chills, decreased blood glucose. Uncommon: Diarrhea, flatulence. Combination with metformin and a sulfonylurea - Common: dizziness, tremor, asthesia, hypoglycemia, hyperhidrosis. Post-marketing experience - hepatitis (reversible with drug discontinuation), urticaria, bullous and exfoliative skin lesions including bullous pemphigoid, pancreatitis, arthralgia, sometimes severe.
Drug Interactions
Vildagliptin has a low potential for drug interactions. No clinically relevant interactions with other oral antidiabetics (glibenclamide, pioglitazone, metformin), amlodipine, digoxin, ramipril, simvastatin, valsartan or warfarin were observed after co-administration with vildagliptin.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BH02 - vildagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.
Presentation/Packing
Tab 50 mg x 2 x 14's.
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