Medical Information

Seladelpar is contraindicated for patients with severe liver dysfunction (Child Pugh C) and biliary obstruction, and should be used with caution and strengthened monitoring for patients with moderate to mild liver injury. Before medication, a comprehensive assessment of liver function and biliary patency is necessary to ensure medication safety.

1、 Severe liver dysfunction patients

1.1 Definition

Child Pugh C grade (decompensated cirrhosis) or serum total bilirubin>3 × ULN with elevated transaminases are absolutely contraindicated.

1.2 Prohibition Basis

When severe liver injury occurs, drug metabolism slows down, which significantly increases the risk of cumulative liver toxicity.

1.3 Clinical recommendations

Prohibited: Patients in this category should not initiate Seladelar treatment.

Mild to moderate liver damage (Child Pugh A/B): Use with caution under the guidance of a doctor and regularly monitor liver function.

2、 Patients with biliary obstruction

2.1 Definition

Including extrahepatic biliary obstruction (such as stones, tumor compression) and late stage primary biliary cholangitis (PBC) with biliary stenosis.

2.2 Prohibition Basis

Biliary obstruction affects drug excretion and may increase the risk of drug-related adverse reactions.

2.3 Clinical recommendations

Prohibited: It is not recommended to use it for patients with biliary obstruction.

If the obstruction has been relieved (such as stent implantation, surgical drainage) and liver function is stable, medication can only be considered after reassessment by a specialist doctor.

3、 Other alert groups

3.1 Pregnancy and lactation period

Lack of safety data, prohibited during pregnancy, and weighing the pros and cons during lactation.

3.2 Individuals allergic to the ingredients of this product

Individuals with a clear history of allergies are prohibited from using it.