17.1 Instructions
Patients should be informed of the potential risks and benefits of JUVISYNC and of alternative modes of therapy. Patients should also be informed about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and A1C testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be advised to seek medical advice promptly.
Patients should be informed that acute pancreatitis has been reported during postmarketing use of sitagliptin. Patients should be informed that persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting, is the hallmark symptom of acute pancreatitis. Patients should be instructed to promptly discontinue JUVISYNC and contact their physician if persistent severe abdominal pain occurs [see Warnings and Precautions (5.1)].
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 be swallowed whole and never split, crushed or chewed.
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 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 rhabd |
