URSOFALK

What it is

Ursofalk contains ursodeoxycholic acid 250 mg per capsule as the active ingredient. The medicine is presented as white hard gelatine capsules containing white or almost white powder.

Approved indications

— Chronic cholestatic liver diseases.

Dosing overview

For primary biliary cirrhosis and chronic cholestatic liver diseases other than cystic fibrosis-related cholestasis and primary sclerosing cholangitis, the recommended dosage is 12–16 mg/kg body weight per day. For cystic fibrosis-related cholestasis, the recommended dose is 20 mg/kg per day. For primary sclerosing cholangitis, the dosage of 10–15 mg/kg body weight per day is recommended. For primary biliary cirrhosis patients, during the first three months of treatment, Ursofalk capsules should be taken in two to three doses over the day, and with improvement of liver function parameters, the daily dose may be taken as a single dose in the evening. For other cholestatic liver diseases, Ursofalk capsules should be taken in two to three doses over the day.

Key safety warnings

During the first three months of therapy, liver parameters (AST, ALT, and GGT) should be monitored every four weeks, then every three months. This monitoring enables identification of treatment responders and non-responders, and early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis. Ursofalk is not recommended in patients with dominant stenoses of the bile ducts unless the obstructed bile ducts are dilated. Long periods of high dose Ursofalk therapy (28–30 mg/kg) in patients with primary sclerosing cholangitis may be associated with a higher rate of serious adverse events. If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, therapy should be discontinued. Some drugs such as cholestyramine, charcoal, colestipol and certain antacids (containing aluminium hydroxide and/or smectite) bind to ursodeoxycholic acid in the intestine and inhibit its absorption and efficacy. These substances must be taken at least two hours before or after Ursofalk.

Contraindications

Ursofalk must not be used if there is hypersensitivity to the active ingredient or any of the excipients.

PBS listing

The 250 mg capsule is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$97.13.

Regulatory history

Ursofalk ursodeoxycholic acid 250 mg capsule was first registered on the ARTG on 24 May 1999. In March 2017, the PBAC recommended Ursofalk for PBS listing for primary biliary cirrhosis with streamlined authority required restriction. In March 2023, the PBAC recommended Ursofalk for primary biliary cholangitis.