Application Nr Approved Date Route Status External Links
BLA208673 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Soliqua 100/33 Is A Combination Of Insulin Glargine And Lixisenatide And Is Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. Soliqua 100/33 Is A Combination Of A Long-Acting Human Insulin Analog With 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 ( 1 ) : Has Not Been Studied In Patients With A History Of Pancreatitis. Consider Other Antidiabetic Therapies In Patients With A History Of Pancreatitis. Not Recommended For Use In Combination With Any Other Product Containing A Glp-1 Receptor Agonist. Not For Treatment Of Type 1 Diabetes Mellitus Or Diabetic Ketoacidosis. Not Recommended For Use In Patients With Gastroparesis. Has Not Been Studied In Combination With Prandial Insulin. Limitations Of Use : Soliqua 100/33 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. Soliqua 100/33 Is Not Recommended For Use In Combination With Any Other Product Containing A Glp-1 Receptor Agonist [See Warnings And Precautions (5.5) ]. Soliqua 100/33 Is Not Indicated For Use In Patients With Type 1 Diabetes Mellitus Or For The Treatment Of Diabetic Ketoacidosis. Soliqua 100/33 Has Not Been Studied In Patients With Gastroparesis And Is Not Recommended In Patients With Gastroparesis. Soliqua 100/33 Has Not Been Studied In Combination With Prandial Insulin.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

Name Structure ZINC ID(s)
1. Insulin Glargine
2. Lixisenatide

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