Managed Care - January 2008 - (Page 19) JANUMET is indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes mellitus who are not adequately controlled on metformin or sitagliptin alone or in patients already being treated with the combination of sitagliptin and metformin. JANUMET should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUMET is contraindicated in patients with renal disease or renal dysfunctiona or abnormal creatinine clearance; or acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Temporarily discontinue JANUMET in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials. Measure renal function before initiation and periodically thereafter. Avoid use in patients with hepatic disease. Temporarily discontinue for intercurrent serious conditions, infection, or surgery. WARNING: LACTIC ACIDOSIS Lactic acidosis is a rare, but serious complication that 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. The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate. If acidosis is suspected, JANUMET should be discontinued and the patient hospitalized immediately [see Warnings and Precautions]. When lactic acidosis occurs, it is fatal in approximately 50% of cases. 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). Reported cases of lactic acidosis have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Use with medications known to cause hypoglycemia Sitagliptin In clinical trials of sitagliptin as monotherapy and sitagliptin as part of combination therapy with metformin or pioglitazone, rates of hypoglycemia reported with sitagliptin were similar to rates in patients taking placebo. The use of sitagliptin in combination with medications known to cause hypoglycemia, such as sulfonylureas or insulin, has not been adequately studied. Metformin hydrochloride Hypoglycemia does not occur in patients receiving metformin alone under usual circumstances of use, but could occur when caloric intake is deficient, when strenuous exercise is not compensated by caloric supplementation, or during concomitant use with other glucose-lowering agents (such as sulfonylureas and insulin) or ethanol. Elderly, debilitated, or malnourished patients, and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. In clinical studies, the most common adverse experience in sitagliptin monotherapy reported, regardless of investigator assessment of causality, in ≥5% of patients and more commonly than in patients given placebo, was nasopharyngitis. The most common (>5%) established adverse reactions due to initiation of metformin therapy are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. JANUMET is a trademark of Merck & Co., Inc. Copyright ©2007 Merck & Co., Inc. All rights reserved. 20704475(2)(103)-JMT JANUMET — HELPS POWER PAST OBSTACLES TO GET MORE PATIENTS TO GOAL For patients uncontrolled on metformin alone, JANUMET provides • Significant A1C reductions vs metformin alone—more than twice as many patients achieve ADAb A1C goal <7% • Weight loss comparable to metformin alone with no increased risk for hypoglycemia, edema, or GI disturbances1 • Comprehensive mechanism that targets all 3 key defects for improved glycemic control Before prescribing JANUMET, please read the Brief Summary of the Prescribing Information, including the Boxed Warning about lactic acidosis, on the adjacent page. a b Serum creatinine levels ≥1.5 mg/dL in males and ≥1.4 mg/dL in females. American Diabetes Association. Reference: 1. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package 20751160(1)-JMT. Janumet.com CHANGING THE COURSE TO GLUCOSE CONTROL http://Janumet.com http://Janumet.com
For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.