Established Safety Profile

Evidence From the TECOS Cardiovascular Safety Trial1

JANUVIA® (Sitagliptin) met the primary end point1 

No increased CV risk on a composite end point of time to the first confirmed event of1:

  • Januvia and Janumet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
  • Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis. If pancreatitis is suspected, Januvia or Janumet should be discontinued; if confirmed, Januvia or Janumet should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Resolution of pancreatitis has been observed after discontinuation of sitagliptin, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
  • Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea. Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea or insulin may be considered.
  • For Januvia only – Renal Impairment: Lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis.
  • Janumet is contraindicated in patients with GFR < 30mL/min and should be temporarily discontinued during conditions with the potential to alter renal function.
  1. Green JB, Bethel MA, Armstrong PW, et al. Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2015;373(3):232–242.