URSO

What it is

URSO is ursodeoxycholic acid (UDCA) . URSO is available as a capsule containing 250 mg UDCA, a suspension containing 50 mg/mL UDCA, and a tablet containing 500 mg UDCA .

Approved indications

— Chronic cholestatic liver diseases

Dosing overview

For primary biliary cholangitis (PBC) and chronic cholestatic liver diseases other than cystic fibrosis-related cholestasis and primary sclerosing cholangitis (PSC), 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 PSC, the recommended dosage is 10–15 mg/kg body weight per day , though 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, URSO capsules, tablets or suspension should be taken in 2 to 3 doses over the day in the first 3 months of treatment; with improvement of the liver function parameters, the daily dose may be taken as a single dose in the evening . For other cholestatic liver diseases, URSO capsules, tablets or suspension should be taken in 2 to 3 doses over the day . For patients under 34 kg or patients who are unable to swallow URSO capsules or tablets, URSO suspension should be used .

Key safety warnings

During the first three months of therapy, it is advisable to monitor liver parameters of AST, ALT, and GGT every 4 weeks, subsequently every 3 months, to allow for identification of responders and non-responders and to enable early detection of potential hepatic deterioration . URSO is not recommended in patients with dominant stenoses of the bile ducts unless the obstructed bile ducts are dilated . For PSC patients, dominant stenoses of the bile ducts should be dilated before and during treatment with URSO . Long periods of high dose UDCA 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, the therapy should be discontinued .

Contraindications

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

Key adverse effects

UDCA is generally well tolerated with few side effects, with diarrhoea being the main reported side effect . The incidence of diarrhoea in controlled studies was up to 3% . Some patients may experience increased pruritus in the early weeks of treatment; in such cases a dose reduction, and thereafter a slow weekly increase of dose to the recommended dose, may help . Severe right upper abdominal pain has occurred during the treatment of PBC (≤1 in 10,000 patients) . Allergic reactions have been reported in some patients, with urticaria occurring in ≤1 in 10,000 patients .

Regulatory history

URSO Capsules 250 mg were first included in the ARTG on 24 May 1999 . URSO Suspension 50 mg/mL were first included in the ARTG on 1 August 2000 . URSO Tablets 500 mg were first included in the ARTG on 6 October 2016 .