Proglin Special Precautions

General: Vildagliptin (Proglin) is not a substitute for insulin in patients requiring insulin. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Special populations: Patients with Hepatic impairment: Not recommended in patients with hepatic impairment, including patients with a pretreatment ALT or AST >2.5x ULN.
Hepatic enzyme monitoring: 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 (LFTs) returned to normal after discontinuation of treatment. LFTs should be performed prior to the initiation of treatment. LFTs should be monitored during treatment 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 to normal.
Should an increase in AST or ALT of 3x ULN or greater persist, withdrawal of therapy is recommended. Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue treatment and contact their physician immediately.
Following withdrawal of treatment and LFT normalization, vildagliptin treatment should not be reinitiated.
Heart failure: A clinical trial of vildagliptin in patients with New York Heart Association (NYHA) functional class I‑III showed that treatment with vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing congestive heart failure (CHF) versus placebo. Clinical experience in patients with NYHA functional class III treated with vildagliptin is still limited and the results are inconclusive (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class IV and therefore use is not recommended in these patients.