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1 Indications And Usage Rybelsus Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus [See Clinical Studies ( 14.1 )] . Limitations Of Use • Rybelsus Is Not Recommended As A First-Line Therapy For Patients Who Have Inadequate Glycemic Control On Diet And Exercise Because Of The Uncertain Relevance Of Rodent C-Cell Tumor Findings To Humans [See Warnings And Precautions ( 5.1 )]. • Rybelsus 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 )] . • Rybelsus Is Not Indicated For Use In Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Patients With Diabetic Ketoacidosis, As It Would Not Be Effective In These Settings. Rybelsus 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 ). 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 ( 1 , 5.2 ). • Not Indicated For Use In Patients With Type 1 Diabetes Mellitus Or Treatment Of Diabetic Ketoacidosis ( 1 ).
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