Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM as monotherapy, or in combination w/ metformin, sulfonylurea, or PPARγ agonist (ie, thiazolidinediones) as initial therapy, or combination w/ metformin & sulfonylurea, or metformin & PPARγ agonist (ie, thiazolidinediones), when single agent alone or dual therapy, w/ diet & exercise, does not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in combination w/ insulin (w/ or w/o metformin).
100 mg once daily as monotherapy or combination therapy w/ metformin, sulfonylurea, insulin (w/ or w/o metformin), PPARγ agonist (eg, thiazolidinediones), metformin + sulfonylurea, or metformin + PPARγ agonist. Renal impairment w/ eGFR ≥30 to <45 mL/min/1.73 m2 50 mg once daily, ≥15 to <30 mL/min/1.73 m2 or ESRD (eGFR <15 mL/min/1.73 m2) requiring hemodialysis or peritoneal dialysis 25 mg once daily, may be administered w/o regard to timing of dialysis.
Serious hypersensitivity reactions including anaphylaxis, angioedema & exfoliative skin reactions eg, SJS. Discontinue use if signs/symptoms of hypersensitivity reactions occur; pancreatitis or bullous pemphigoid is suspected. Not to be used in patients w/ type I diabetes, diabetic ketoacidosis, severe infection, or serious accident. Acute pancreatitis including fatal & non-fatal hemorrhagic & necrotizing pancreatitis; bullous pemphigoid. May increase risk of severe joint pain. Patients w/ history of pancreatitis; angioedema w/ other DPP-4 inhibitor use. Monitor for signs & symptoms of pancreatitis. Not to be used concomitantly w/ alcohol. Greater incidence of hypoglycemia when used in combination w/ sulfonylurea or insulin. Moderate to severe renal dysfunction & ESRD requiring hemodialysis or peritoneal dialysis. Not recommended in pregnancy. Not to be used by nursing woman.
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