Increased risk of hypoglycaemia with concomitant sulfonylureas, dose reduction may be necessary. Increased serum levels with CYP3A4/5 inhibitors (e.g. atazanavir, ketoconazole, nefazodone, ritonavir). Concomitant CYP3A4 inducers (e.g. carbamazepine, phenobarbital) may reduce the glycaemic lowering effect of saxagliptin.
Type 1 diabetes, diabetic ketoacidosis.
The following serious adverse reactions are described below or elsewhere in the prescribing information: Pancreatitis, Heart Failure, Hypoglycemia with Concomitant Use of Sulfonylurea or Insulin, Hypersensitivity Reactions, Severe and disabling arthralgia, Bullous pemphigoid
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Moderate and severe renal impairment. Pregnancy and lactation.
Mild Renal Impairment: No dosage adjustment needed.
Moderate to Severe including with ESRD requiring hemodialysis: 2.5 mg once daily.
Hepatic Impairment No dosage adjustment.
