Galvus Special Precautions



Novartis Indonesia
Full Prescribing Info
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.
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