Ursofalk® (ursodeoxycholic acid) available on PBS for Primary Biliary Cirrhosis from November 1st 2000

October 2000 Media Release - October 2000


Ursofalk®‚ approved in Australia for the treatement of cholestatic liver diseases1, will be made available through the Pharmaceutical Benefits Scheme from November 1st, 2000, Authority Required (100 capsules + 2 repeats), for the treatment of Primary Biliary Cirrhosis. Primary Biliary Cirrhosis (PBC) is a chronic cholestatic liver disease, characterised by immune-related destruction of small intrahepatic bile ducts. Cholestasis and retention of toxic hydrophobic bile acids cause hepatocyte damage leading to fibrosis and biliary cirrhosis2. Liver transplantation is the only definitive treatment option for end stage disease. Mainly affecting middle-aged women, PBC is characterised by symptoms of pruritus, persistent mental and physical fatigue, and ongoing ill-defined upper abdominal discomfort. Later signs of the complications of more advanced liver disease include jaundice, ascites, bleeding varices and encephalopathy. Diagnosis of PBC is usually made on the basis of abnormal liver enzyme tests and may be confirmed via positive anti-mitochondrial antibody assay results, and compatible or diagnostic liver histology.3 Ursofalk‚ is presented as 250mg capsules (cartons of 100). Please review Product Information before prescribing. A Dosage and Administration guideline chart, and other information on Ursofalk‚ can be requested from Orphan Australia on 1300 656 755. Ursofalk® is a registered trademark of Dr Falk Pharma GmbH.

 


References:
1. Ursofalk Approved Product Information
2. Trauner M & Graziadei IW Aliment Pharmacol Ther 1999; 13: 979-995.
3. James OFW in Primary Biliary Cirrhosis, Neuberger J(ed). West End Studios Pty Ltd., Eastbourne, UK.1999: 53-54.