Managed Care - February 2008 - (Page 43) In type 2 diabetes JANUVIA — Explore the possibilities The first and only DPP-4 inhibitor a Enhancing incretins. Enhancing physiologic glucose control. • Powerful reductions as monotherapy—significant complementary A1C effect when added to metformin or a TZD • One tablet, once daily, proven to deliver 24-hour glycemic control without weight gain or increased risk of hypoglycemia • Glucose-dependent mechanism targets 2 key defects: insulin release and hepatic glucose production JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus. JANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. JANUVIA has not been studied in combination with insulin. JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. A dosage adjustment is recommended in patients with moderate or severe renal insufficiency or with end-stage renal disease requiring hemodialysis or peritoneal dialysis. As is typical with other antihyperglycemic agents used in combination with a sulfonylurea, when JANUVIA was used in combination with a sulfonylurea, a class of medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo. Therefore, a lower dose of sulfonylurea may be required to reduce the risk of hypoglycemia. There have been postmarketing reports of serious hypersensitivity reactions in patients treated with JANUVIA, such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Onset of these reactions occurred within the first 3 months after initiation of treatment with JANUVIA, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue JANUVIA, assess for other potential causes for the event, and institute alternative treatment for diabetes. In clinical studies, the adverse reactions, regardless of investigator assessment of causality, in ≥5% of patients treated with JANUVIA as monotherapy and in combination and more commonly than in patients treated with placebo, were upper respiratory tract infection, nasopharyngitis, and headache. Before prescribing JANUVIA, please read the adjacent Brief Summary of the Prescribing Information. For more information, please visit Januvia.com DPP-4=dipeptidyl peptidase-4; TZD=thiazolidinedione. a IMS Health, NPA Plus TM, TRXs, week ending October 20, 2006–week ending September 21, 2007. JANUVIA is a trademark of Merck & Co., Inc. Copyright © 2007 Merck & Co., Inc. All rights reserved. 20703589(5)(704)-JAN http://Januvia.com http://Januvia.com
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