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1 Indications And Usage Tanzeum 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: • Tanzeum Is Not Recommended As First-Line Therapy For Patients Inadequately Controlled On Diet And Exercise Because Of The Uncertain Relevance Of The Rodent C-Cell Tumor Findings To Humans. Prescribe Tanzeum Only To Patients For Whom The Potential Benefits Are Considered To Outweigh The Potential Risk [See Warnings And Precautions (5.1)] . • Tanzeum Has Not Been Studied In Patients With A History Of Pancreatitis [See Warnings And Precautions (5.2)] . Consider Other Antidiabetic Therapies In Patients With A History Of Pancreatitis. • Tanzeum Is Not Indicated In The Treatment Of Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Patients With Diabetic Ketoacidosis. Tanzeum Is Not A Substitute For Insulin In These Patients. • Tanzeum Has Not Been Studied In Patients With Severe Gastrointestinal Disease, Including Severe Gastroparesis. The Use Of Tanzeum Is Not Recommended In Patients With Pre-Existing Severe Gastrointestinal Disease [See Adverse Reactions (6.1)]. • Tanzeum Has Not Been Studied In Combination With Prandial Insulin. Tanzeum Is A Glp-1 Receptor Agonist Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. ( 1 ) Limitations Of Use: • Not Recommended As First-Line Therapy For Patients Inadequately Controlled On Diet And Exercise. ( 1 , 5.1 ) • 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 ) • Not For Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis. ( 1 ) • Not For Patients With Pre-Existing Severe Gastrointestinal Disease. ( 1 ) • Has Not Been Studied In Combination With Prandial Insulin. ( 1 )
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