Tools for Health Care Professionals

• Print
• Share
• Bookmark
• Text Size:

Selected Important Risk Information About JANUMET

JANUMET is contraindicated in patients with renal disease or renal dysfunction (serum creatinine levels >1.5 mg/dL in males and >1.4 mg/dL in females) or abnormal creatinine clearance; acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma; or history of a serious hypersensitivity reaction to JANUMET or sitagliptin (one of the components of JANUMET), such as anaphylaxis or angioedema.

Temporarily discontinue JANUMET in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. Avoid use in patients with hepatic disease. Temporarily discontinue for intercurrent serious conditions, infection, or surgery.

There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis.

Measure renal function before initiation of therapy with JANUMET and periodically thereafter. In patients in whom development of renal dysfunction is anticipated, particularly in elderly patients, renal function should be assessed more frequently and JANUMET discontinued if evidence of renal impairment is present.

Please read the Boxed Warning for JANUMET about lactic acidosis.