( or behavioral toxicity was observed in...)Late Breaking Data Released at ADA Showed that the Investigational,Use of Januvia and Metformin as Initial Combination Therapy,Provided Significant Glucose Lowering Efficacy over 54 Weeks in,Patients with Type 2 Diabetes,Health

or behavioral toxicity was observed in offspring of rats. Placental transfer of sitagliptin administered to pregnant rats was approximately 45% at 2 hours and 80% at 24 hours postdose. Placental transfer of sitagliptin administered to pregnant rabbits was approximately 66% at 2 hours and 30% at 24 hours. 8.3 Nursing Mothers Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when JANUVIA is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness of JANUVIA in pediatric patients have not been established. 8.5 Geriatric Use Of the total number of subjects (N=3884) in clinical safety and efficacy studies of JANUVIA, 725 patients were 65 years and over, while 61 patients were 75 years and over. No overall differences in safety or effectiveness were observed between subjects 65 years and over and younger subjects. While this and other reported clinical experience have not identified differences in responses between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in the elderly, and it may be useful to assess renal function in these patients prior to initiating dosing and periodically thereafter (see Dosage and Administration (2.2); Clinical Pharmacology (12.3)). 10 OVERDOSAGE During controlled clinical trials in healthy subjects, single doses of up to 800 mg JANUVIA were administered. Maximal mean increases in QTc of 8.0 msec were observed in one study at a dose of 800 mg JANUVIA, a mean effect that is not considered clinically important (see Clinical Pharmacology (12.2))
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