|
1 Indications And Usage Bydureon Bcise 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 Bcise 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 Bcise Is Not A Substitute For Insulin. Bydureon Bcise 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 Bcise With Prandial Insulin Has Not Been Studied [See Clinical Studies (14) ] . • Bydureon Bcise Is An Extended-Release Formulation Of Exenatide. Bydureon Bcise Should Not Be Used With Other Products Containing The Active Ingredient Exenatide. • Bydureon Bcise 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 (5.2) And Adverse Reactions (6.3) ] . Bydureon Bcise 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 Bcise 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 , 5.2)
|