HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use JANUMET safely and effectively. See full prescribing information for JANUMET.

JANUMET® (sitagliptin/metformin HCl) tablets
Initial U.S. Approval: 2007

 
WARNING: LACTIC ACIDOSIS

See full prescribing information for complete boxed warning.

Lactic acidosis can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic insufficiency, renal impairment, and acute congestive heart failure. (5.1)
Symptoms include malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. (5.1)
If acidosis is suspected, discontinue JANUMET and hospitalize the patient immediately. (5.1)
 
RECENT MAJOR CHANGES
Warnings and Precautions

Assessment of Renal Function (5.4) 04/2011

 
INDICATIONS AND USAGE
JANUMET is a dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. (1)

Important Limitations of Use:

JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. (1)
JANUMET has not been studied in patients with a history of pancreatitis. (1, 5.2)

 
DOSAGE AND ADMINISTRATION
Individualize the starting dose of JANUMET based on the patient’s current regimen. (2.1)
May adjust the dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. (2.1)
JANUMET should be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin. (2.1)

 
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg sitagliptin/500 mg metformin HCl and 50 mg sitagliptin/1000 mg metformin HCl (3)

 
CONTRAINDICATIONS
Renal dysfunction, e.g., serum creatinine ≥1.5 mg/dL [males], ≥1.4 mg/dL [females] or abnormal creatinine clearance. (4, 5.1, 5.4)
Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. (4, 5.1)
History of a serious hypersensitivity reaction to JANUMET or sitagliptin (one of the components of JANUMET), such as anaphylaxis or angioedema. (5.14, 6.2)
Temporarily discontinue JANUMET in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. (4, 5.1, 5.11)

 
WARNINGS AND PRECAUTIONS
Do not use JANUMET in patients with hepatic disease. (5.1, 5.3)
There have been postmarketing reports of acute renal failure, sometimes requiring dialysis. Before initiating JANUMET and at least annually thereafter, assess renal function and verify as normal. (4, 5.1, 5.4, 5.10, 6.2)
There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue JANUMET. (5.2)
Measure hematologic parameters annually. (5.5, 6.1)
Warn patients against excessive alcohol intake. (5.1, 5.6)
May need to dis