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obeticholic acid; 6-ethylchenodeoxycholic acid; 6-ECDCA (Ocaliva)

Indications: - adjunctive treatment to ursodeoxycholic acid in patients with primary biliary cholangitis [4,6] Contraindications: - advanced cirrhosis [7] - no clinical benefit per FDA [8] Dosage: - start 5 mg weekly [5] - max: 10 mg weekly [4] * incorrectly dosed daily [3] instead of weekly [5] Mechanism of action: - farnesoid X receptor agonist [6]

Related

tropifexor

General

carboxylate gastrointestinal agent

Database Correlations

PUBCHEM correlations

References

  1. PubChem: 447715
  2. PubMed Health Obeticholic Acid (Oral route) (Ocaliva) https://www.ncbi.nlm.nih.gov/pubmedhealth/?term=Obeticholic+Acid
  3. DailyMed OBETICHOLIC ACID http://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=OBETICHOLIC+ACID
  4. Anello J, Feinberg B, Heinegg J et al Primary Biliary Cholangitis Guidelines on primary biliary cholangitis by the European Association for the Study of the Liver. Medscape: New Guidelines and Recommendations, August 2017. http://reference.medscape.com/viewarticle/884517
  5. MedWatch - The FDA Safety Information and Adverse Event Reporting Program. Feb 1, 2018 Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm594901.htm
  6. Susman E. Biliary Fibrosis Stabilized with Obeticholic Acid. Biopsy study supports anti-fibrosis properties of agent. MedPage Today. April 15, 2018 https://www.medpagetoday.com/meetingcoverage/easl/72354 - Bowlus C, et al Long-Term Obeticholic Acid treatment associated with reversal or stabilization of fibrosis/cirrhosis in patients with Primary Biliary Cholangitis (PBC). European Association for the Study of the Liver (EASL) 2018. Abstract LBP-014.
  7. Hamza Z FDA Restricts Ocaliva Use in Primary Biliary Cholangitis. Liver failure, need for liver transplant reported in patients with advanced cirrhosis. MedPage Today May 27, 2021 https://www.medpagetoday.com/gastroenterology/generalhepatology/92819 - FDA Drug Safety Communication. May 25, 2021 Due to risk of serious liver injury, FDA restricts use of Ocaliva in primary biliary cholangitis (PBC) patients with advanced cirrhosis. https://www.fda.gov/drugs/drug-safety-and-availability/due-risk-serious-liver-injury-fda-restricts-use-ocaliva-primary-biliary-cholangitis-pbc-patients
  8. Lou N Approved Liver Disease Drug Has No Clinical Benefit, FDA Panel Says. Agency advisors put their foot down on shaky science for Ocaliva in primary biliary cholangitis. MedPage Today September 13, 2024 https://www.medpagetoday.com/gastroenterology/generalhepatology/111955