Indications and Purposes
| 1 Indications And Usage Cholbam Is A Bile Acid Indicated For: Treatment Of Bile Acid Synthesis Disorders Due To Single Enzyme Defects (Seds). ( 1.1 ) Adjunctive Treatment Of Peroxisomal Disorders (Pds) Including Zellweger Spectrum Disorders In Patients Who Exhibit Manifestations Of Liver Disease, Steatorrhea Or Complications From Decreased Fat Soluble Vitamin Absorption ( 1.2 ) Limitation Of Use: The Safety And Effectiveness Of Cholbam On Extrahepatic Manifestations Of Bile Acid Synthesis Disorders Due To Seds Or Pds Including Zellweger Spectrum Disorders Have Not Been Established. ( 1.3 ). 1.1 Bile Acid Synthesis Disorders Due To Single Enzyme Defects Cholbam Is Indicated For The Treatment Of Bile Acid Synthesis Disorders Due To Single Enzyme Defects (Seds) [See Clinical Trials (14.1) ]. 1.2 Peroxisomal Disorders Including Zellweger Spectrum Disorders Cholbam Is Indicated For Adjunctive Treatment Of Peroxisomal Disorders (Pds) Including Zellweger Spectrum Disorders In Patients Who Exhibit Manifestations Of Liver Disease, Steatorrhea Or Complications From Decreased Fat Soluble Vitamin Absorption [See Clinical Trials (14.2) ]. 1.3 Limitation Of Use The Safety And Effectiveness Of Cholbam On Extrahepatic Manifestations Of Bile Acid Synthesis Disorders Due To Seds Or Pds Including Zellweger Spectrum Disorders Have Not Been Established. |
All Formulated Excipients (0 Total)
None
Active Ingredients ( 1 Total)
| Name | Structure | ZINC ID(s) |
|---|---|---|
| 1. Cholic Acid |