Not a substitute for insulin. Not for use in patients w/ type 1 diabetes & not for treatment of diabetic ketoacidosis. Not recommended in patients w/ hepatic impairment w/ pre-treatment ALT/AST >2.5 times ULN. Perform LFT prior to treatment initiation, & monitor at 3-mth intervals during the 1st yr of treatment & periodically thereafter. W/draw therapy if an increase in AST/ALT ≥3 times ULN persist. Discontinue in patients who develop jaundice or other signs suggestive of liver dysfunction. Limited clinical experience & inconclusive results in patients w/ NYHA functional class III. Not recommended in patients w/ NYHA functional class IV. Should not be used during pregnancy unless benefit to the mother outweighs potential risk to fetus. Should not be administered to breast-feeding women. Not recommended in childn <18 yr.
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