Pharmacy & Therapeutics - February 2009 - (Page 89)

Important Information JANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults 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 reported, regardless of investigator assessment of causality, in ≥5% of patients treated with JANUVIA as monotherapy and in combination therapy 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 appropriate patients, when you have decided not to use metformin JANUVIA: Powerful Choice. Powerful A1C Reductions. For more information, please visit Januvia.com/hcp a IMS Health, NPATM Weekly, TRxs, week ending October 20, 2006, through week ending November 28, 2008. JANUVIA is a registered trademark of Merck & Co., Inc. Copyright ©2009 Merck & Co., Inc. All rights reserved. 20902020(1)(706)-JAN http://www.Januvia.com/hcp http://www.Januvia.com/hcp

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - February 2009

Pharmacy & Therapeutics - February 2009 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/New Medical Devices Drug Forecast Pushing an Expanded Role for Pharmacists Better Asthma Management with Advanced Technology Pharmaceutical Approval Update 58th Annual Meeting, American Society of Human Genetics, 2008 American Society of Hematology, 50th Annual Meeting and Exposition 2008 San Antonio Breast Cancer Symposium Stahl’s Essential Psychopharmacology, 3rd Edition Author Guidelines

Pharmacy & Therapeutics - February 2009

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