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Acute pancreatitis, including fatal and nonfatal hemorrhagic and necrotizing pancreatitis, has been reported; monitoring recommended and discontinue therapy if signs or symptoms develop.
Heart failure may occur; monitoring recommended and consider discontinuation.
Sitagliptin phosphate is not indicated for use in patients with type 1 diabetes mellitus.
Sitagliptin phosphate is not indicated for the treatment of diabetes ketoacidosis.
Severe and disabling arthralgia has been reported with DPP-IV inhibitor use; onset may occur within 1 day to years after treatment initiation and may resolve with discontinuation of therapy. Some patients may experience a recurrence of symptoms if DPP-IV inhibitor therapy resumed.
Serious hypersensitivity and allergic reactions such as angioedema, anaphylaxis and Stevens-Johnson syndrome have been reported, particularly within first 3 months of treatment.
Sitagliptin phosphate requires a dosage adjustment in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis. There have been reports of worsening renal function and acute renal failure requiring dialysis in patients treated with Sitagliptin phosphate.
Bullous pemphigoid has been reported with dipeptidyl peptidase-4 inhibitors; if blisters or erosions develop during treatment and bullous pemphigoid is suspected, discontinue treatment and medically manage.
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