基本信息
文件名称：奥贝胆酸(ObeticholicAcid,商品名Ocaliva)片的说明书（FDA）.pdf
文件大小：505.35 KB
总页数：21 页
更新时间：2025-06-11
总字数：约8.43万字
文档摘要

ThislabelmaynotbethelatestapprovedbyFDA.

Forcurrentlabelinginformation,pleasevisit/drugsatfda

HIGHLIGHTSOFPRESCRIBINGINFORMATIONRoutinelymonitorpatientsduringOCALIVAtreatmentforbiochemical

Thesehighlightsdonotincludealltheinformationneededtouseresponse,tolerability,andprogressionofPBC.(2.3)

OCALIVA?safelyandeffectively.SeefullprescribinginformationforManagementofPatientswithIntolerablePruritus

OCALIVA.?Seefullprescribinginformationformanagementoptions.(2.4)

?AdministrationInstructions

OCALIVA(obeticholicacid)tablets,fororaluse

?Takewithorwithoutfood.(2.5)

InitialU.S.Approval:2016

?Forpatientstakingbileacidbindingresins,takeOCALIVAatleast4hours

beforeor4hoursaftertakingabileacidbindingresin,oratasgreatan

WARNING:HEPATICDECOMPENSATIONANDFAILUREIN

intervalaspossible.(7.1)

PRIMARYBILIARYCHOLANGITISPATIENTSWITHCIRRHOSIS

Seefullprescribinginformationforcompleteboxedwarning___