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1 Indications And Usage Xultophy 100/3.6 Is A Combination Of Insulin Degludec And Liraglutide And Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. Limitations Of Use: • Xultophy 100/3.6 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 Rodent C-Cell Tumor Findings To Humans [See Warnings And Precautions ( 5.1 )] . • Xultophy 100/3.6 Is Not Recommended For Use In Combination With Any Other Product Containing Liraglutide Or Another Glp-1 Receptor Agonist [See Warnings And Precautions ( 5.5 )]. • Xultophy 100/3.6 Is Not Indicated For Use In Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Diabetic Ketoacidosis. • Xultophy 100/3.6 Has Not Been Studied In Combination With Prandial Insulin. Xultophy 100/3.6 Is A Combination Of Insulin Degludec, A Long-Acting Human Insulin Analog, And Liraglutide, 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. Limitations Of Use ( 1 ): • Not Recommended As First-Line Therapy For Patients Inadequately Controlled On Diet And Exercise. • Not Recommended For Use In Combination With Any Other Product Containing Liraglutide Or Another Glp-1 Receptor Agonist. • Not For Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis. • Has Not Been Studied In Combination With Prandial Insulin.
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