Application Nr Approved Date Route Status External Links
BLA125469 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Trulicity ® Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. Trulicity ® 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. Limitations Of Use: Not Recommended As First-Line Therapy For Patients Inadequately Controlled On Diet And Exercise ( 1.1 , 5.1 ). Has Not Been Studied In Patients With A History Of Pancreatitis. Consider Another Antidiabetic Therapy ( 1.1 , 5.2 ). Not For Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis ( 1.1 ). Not For Patients With Pre-Existing Severe Gastrointestinal Disease ( 1.1 , 5.6 ). 1.1 Limitations Of Use Trulicity 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. Prescribe Trulicity Only To Patients For Whom The Potential Benefits Outweigh The Potential Risk [See Warnings And Precautions ( 5.1 )]. Trulicity 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. Trulicity Should Not Be Used In Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Diabetic Ketoacidosis. Trulicity Is Not A Substitute For Insulin. Trulicity Has Not Been Studied In Patients With Severe Gastrointestinal Disease, Including Severe Gastroparesis. The Use Of Trulicity Is Not Recommended In Patients With Pre-Existing Severe Gastrointestinal Disease [See Warnings And Precautions ( 5.6 )] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Dulaglutide

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