Renal disease or renal function impairment (eg, serum creatinine levels at least 1.5 mg/dL [males] and at least 1.4 mg/dL [females]); acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma; history of a serious hypersensitivity reaction, such as anaphylaxis or angioedema, to any component of the product.