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1 Indications And Usage Bydureon Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus [See Clinical Studies (14) ] . Limitations Of Use : • Bydureon Is Not Recommended As First-Line Therapy For Patients Who Have Inadequate Glycemic Control On Diet And Exercise Because Of The Uncertain Relevance Of The Rat Thyroid C-Cell Tumor Findings To Humans [See Warnings And Precautions (5.1) ] . • Bydureon Is Not A Substitute For Insulin. Bydureon Is Not Indicated For Use In Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Diabetic Ketoacidosis, As It Would Not Be Effective In These Settings. • The Concurrent Use Of Bydureon With Prandial Insulin Has Not Been Studied. • Bydureon Is An Extended-Release Formulation Of Exenatide. Bydureon Should Not Be Used With Other Products Containing The Active Ingredient Exenatide. • Bydureon Has Not Been Studied In Patients With A History Of Pancreatitis. Consider Other Antidiabetic Therapies In Patients With A History Of Pancreatitis [See Warnings And Precautions (5.3) And Adverse Reactions (6.1) ] . Bydureon Is A Glucagon-Like Peptide-1 (Glp-1) Receptor Agonist Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. ( 1, 14 ) Limitations Of Use: • Not Recommended As First-Line Therapy For Patients Inadequately Controlled On Diet And Exercise. ( 1 ) • Should Not Be Used To Treat Type 1 Diabetes Or Diabetic Ketoacidosis. ( 1 ) • Use With Prandial Insulin Has Not Been Studied. ( 1 ) • Bydureon Is An Extended-Release Formulation Of Exenatide. Do Not Coadminister With Other Exenatide Containing Products. ( 1 ) • Has Not Been Studied In Patients With A History Of Pancreatitis. Consider Other Antidiabetic Therapies In Patients With A History Of Pancreatitis. ( 1 , 5.3 )
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