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Label Changes for:

Janumet (sitagliptin and metformin HCl) tablets, 50 mg/ 500 mg and 50 mg/ 1000 mg

September 2013

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)


September 2013


JANUMET (sitagliptin/metformin HCl) is contraindicated in patients with:

  • Renal impairment (e.g., serum creatinine levels greater than or equal to 1.5 mg/dL for men, greater than or equal to 1.4 mg/dL for women or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia [see Warnings and Precautions (5.1)].
  • Hypersensitivity to metformin hydrochloride.
  • Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin.


5.1 Lactic Acidosis

Metformin hydrochloride

  • The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal impairment, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. In addition, metformin should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis.
5.4 Assessment of Renal Function
  • Therefore, JANUMET is contraindicated in patients with renal impairment.


  • There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis. Before initiation of therapy with JANUMET and at least annually thereafter, renal function should be assessed and verified as normal. 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.


7.1 Carbonic Anhydrase Inhibitors
  • Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently decrease serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs may induce metabolic acidosis. Use these drugs with caution in patients treated with JANUMET, as the risk of lactic acidosis may increase.


Renal Impairment
  • "insufficiency" changed to "impairment"
Hepatic Impairment
  • "insufficiency" changed to "impairment"


Who should not take JANUMET?

Do not take JANUMET if:

  • your kidneys are not working properly.
  • you have diabetic ketoacidosis. See "What is JANUMET?"

What should I tell my doctor before taking JANUMET?

Before you take JANUMET, tell your doctor if you:

  • are going to get an injection of dye or contrast agents for an x-ray procedure; JANUMET will need to be stopped for a short time. Talk to your doctor about when you should stop JANUMET and when you should start JANUMET again. See “What is the most important information I should know about JANUMET?”

The most common side effects of JANUMET include:

  • low blood sugar (hypoglycemia) when used in combination with certain  medications, such as a sulfonylurea or insulin.