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Obeticholic acid (OCA), sold under the brand name Ocaliva, is a semi-synthetic bile acid analogue which has the chemical structure 6α-ethyl-chenodeoxycholic acid. It is used as a medication used to treat primary biliary cholangitis. Intercept Pharmaceuticals Inc. hold the worldwide rights to develop OCA outside Japan and China, where it is licensed to Dainippon Sumitomo Pharma.
Read the full article on WikipediaPrimary biliary cholangitis (previously known as Primary biliary cirrhosis) Clinical criteria: Treatment Phase: Initial treatment Treatment criteria: Must be treated by a prescriber who is either: (i) a gastroenterologist, (ii) a hepatologist; OR Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, AND Patient must be undergoing concurrent treatment with ursodeoxycholic acid; OR Patient must be undergoing treatment with this drug as monotherapy because treatment with ursodeoxycholic acid is not tolerated/contraindicated, AND Patient must not be undergoing concurrent treatment with elafibranor. Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; OR Patient must have experienced an intolerance/contraindication to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug, AND Patient must not have/be each of: (i) severe liver disease, (ii) immunocompromised, AND Patient must have an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) prior to initiating treatment with this drug, having accounted for each of: (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of 'normal', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; OR Patient must have a total bilirubin level between 1 to 2 times the ULN prior to initiating treatment with this drug, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; OR Patient must have abnormal readings of at least one of: (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid; OR Patient must have experienced an intolerance to elafibranor of a severity requiring treatment discontinuation, prior to initiating treatment with this drug; OR Patient must have inadequately responded to treatment with elafibranor, prior to initiating treatment with this drug. Population criteria: Patient must be at least 18 years of age. Document and retain in the patient's medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the 'Continuing treatment' restriction.
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