Important Information About JANUVIA

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.

The recommended dose of JANUVIA is 100 mg once daily.

A dosage adjustment is recommended in patients with moderate or severe renal insufficiency or with end-stage renal disease requiring hemodialysis or peritoneal dialysis.

No dosage adjustment is required for patients with mild renal insufficiency. For patients with moderate renal insufficiency, the dose of JANUVIA is 50 mg once daily. For patients with severe renal insufficiency or with end-stage renal disease requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily.

JANUVIA is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema.

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.

The incidence of selected gastrointestinal adverse reactions in patients treated with JANUVIA 100 mg vs placebo was as follows: abdominal pain (2.3%, 2.1%), nausea (1.4%, 0.6%), and diarrhea (3.0%, 2.3%).

USE IN SPECIFIC POPULATIONS
There are no adequate and well-controlled studies in pregnant women. Therefore, JANUVIA should be used during pregnancy only if clearly needed.

Merck & Co., Inc., maintains a registry to monitor the pregnancy outcomes of women exposed to JANUVIA while pregnant. Health care providers are encouraged to report any prenatal exposure to JANUVIA by calling the Pregnancy Registry at 1-800-986-8999.

It is not known whether sitagliptin is excreted in human milk. Therefore, caution should be exercised when JANUVIA is administered to a nursing woman.

Safety and effectiveness of JANUVIA in children under 18 years have not been established.

No dosage adjustment is required based on age; however, because JANUVIA is substantially excreted by the kidney, it may be useful to assess renal function in elderly patients before initiation and periodically thereafter.

Before prescribing JANUVIA, please read the Prescribing Information and Patient Product Information.