obeticholic acid; 6-ethylchenodeoxycholic acid; 6-ECDCA (Ocaliva)
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Indications
- adjunctive treatment to ursodeoxycholic acid in patients with primary biliary cholangitis[4][6]
Contraindications
Dosage
* incorrectly dosed daily[3] instead of weekly[5]
Mechanism of action
More general terms
Additional terms
References
- ↑ PubChem: 447715
- ↑ PubMed Health Obeticholic Acid (Oral route) (Ocaliva) https://www.ncbi.nlm.nih.gov/pubmedhealth/?term=Obeticholic+Acid
- ↑ 3.0 3.1 DailyMed OBETICHOLIC ACID http://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=OBETICHOLIC+ACID
- ↑ 4.0 4.1 4.2 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
- ↑ 5.0 5.1 5.2 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
- ↑ 6.0 6.1 6.2 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. - ↑ 7.0 7.1 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