Product Dossier
ARX-URSODEOXYCHOLIC
Product Dossier for ARX-URSODEOXYCHOLIC (ursodeoxycholic acid, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: ursodeoxycholic acid
- Therapeutic area: Gastroenterology
- Related brand: URSODOX
- Related brand: URSOFALK
- Related brand: URSO
- Same area: SALOFALK
- Same area: COLOFAC
What it is
ARX-Ursodeoxycholic acid is available as capsules containing 250 mg ursodeoxycholic acid and tablets containing 500 mg ursodeoxycholic acid.
Approved indications —
Chronic cholestatic liver diseases
Dosing overview
For Primary Biliary Cholangitis (PBC) and chronic cholestatic liver diseases other than Cystic Fibrosis (CF) and Primary Sclerosing Cholangitis (PSC), the recommended dosage is 12–16 mg/kg body weight per day. For CF-related cholestasis, the recommended dose is 20 mg/kg per day. For PSC, the dosage recommended is 10–15 mg/kg body weight per day. A dosage of 20 mg/kg body weight per day has also been shown to improve histology and liver function tests in PSC patients. For PBC patients, in the first three months of treatment ARX-Ursodeoxycholic acid tablets or capsules should be taken in two to three doses over the day, with the daily dose potentially taken as a single dose in the evening once liver function parameters improve. For other cholestatic liver diseases, ARX-Ursodeoxycholic acid tablets or capsules should be taken in two to three doses over the day.
Key safety warnings
During the first three months of therapy, it is advisable to monitor liver parameters of AST, ALT, and GGT every four weeks, subsequently every three months. Ursodeoxycholic acid is not recommended in patients with dominant stenoses of the bile ducts unless the obstructed bile ducts are dilated. If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued. Long periods of high dose ursodeoxycholic acid therapy (28–30 mg/kg) in patients with primary sclerosing cholangitis may be associated with a higher rate of serious adverse events. Ursodeoxycholic acid should not be used during the first three months of pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ursodeoxycholic acid.
Contraindications
ARX-Ursodeoxycholic acid must not be used if there is hypersensitivity to the active ingredient or any of the excipients.
Regulatory history
ARX-Ursodeoxycholic acid Capsules 250 mg and Tablets 500 mg received initial ARTG approval on 8 October 2025.