Patients should be informed that the incidence of hypoglycemia is increased when sitagliptin is added to a sulfonylurea or insulin and that a lower dose of the sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

Patients should be informed that allergic reactions have been reported during postmarketing use of sitagliptin. If symptoms of allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing) occur, patients must stop taking JUVISYNC and seek medical advice promptly.

Patients should be informed that the tablets must never be split or divided before swallowing.

Physicians should instruct their patients to read the Medication Guide before starting JUVISYNC therapy and to reread each time the prescription is renewed. Patients should be instructed to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.

Patients should be advised to adhere to their National Cholesterol Education Program (NCEP)-recommended diet, a regular exercise program, and periodic testing of a fasting lipid panel.

Patients should be advised about substances they should not take concomitantly with JUVISYNC [see Contraindications (4); Warnings and Precautions (5.2)]. Patients should also be advised to inform other healthcare professionals prescribing a new medication or increasing the dose of an existing medication that they are taking JUVISYNC.

17.2 Laboratory Tests
Patients should be informed that response to JUVISYNC should be monitored by periodic measurements of blood glucose, A1C, and cholesterol levels, with a goal of decreasing these levels towards the normal range. A1C is especially useful for eva luating long-term glycemic control. Patients should be informed of the potential need to adjust the dose or discontinue JUVISYNC based on changes in renal function test results over time.

It is recommended that liver function tests be performed before the initiation of JUVISYNC, and thereafter when clinically indicated. All patients treated with JUVISYNC should be advised to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.

17.3 Muscle Pain
All patients starting therapy with JUVISYNC should be advised of the risk of myopathy, including rhabdomyolysis, and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if these muscle signs or symptoms persist after discontinuing JUVISYNC. The risk of myopathy, including rhabdomyolysis, occurring with use of JUVISYNC is increased when taking certain types of medication or consuming grapefruit juice. Patients should discuss all medication, both prescription and over the counter, with their healthcare professional.

17.4 Pregnancy
Women of childbearing age should be advised to use an effective method of birth control to prevent pregnancy while using JUVISYNC. Discuss future pregnancy plans with your patients, and discuss when to stop taking JUVISYNC if they are trying to conceive. Patients should be advised that if they become pregnant they should stop taking JUVISYNC and call their healthcare professional.

17.5 Breastfeeding
Women who are breastfeeding should not use JUVISYNC. Patients who have a