Elafiber poses serious safety risks in specific populations, especially for patients with severe liver dysfunction and biliary obstruction, and must be rigorously evaluated before use. The following three types of situations will be explained one by one.

1、 Severe liver dysfunction patients

Child Pugh Class C: Patients with this condition have extremely poor liver metabolism, significantly delayed drug clearance, and are prone to cumulative toxicity.

Discontinued use in decompensated cirrhosis: It should not be used in patients with ascites, esophageal variceal bleeding, or a history of hepatic encephalopathy.

Discontinue treatment for patients with a sharp increase in liver enzymes: If ALT or AST rises to more than 5 times the upper limit of normal, immediately discontinue medication and investigate the cause.

2、 Patients with biliary obstruction

Obstruction caused by any reason, including gallstones, bile duct tumors, or primary sclerosing cholangitis, is contraindicated.

Patients with obstructive jaundice should not use it: when the total bilirubin is greater than 3mg/dL and the proportion of direct bilirubin is greater than 50%, it indicates obstructed excretion and should not be used.

Prohibited for patients who have not had their gallbladder or bile duct drainage removed after surgery: At this time, bile flow dynamics are unstable and drugs cannot be safely metabolized.

3、 Other clearly prohibited groups

Individuals who are allergic to any of the ingredients in this product: Do not use if they have experienced rash, angioedema, or anaphylactic shock.

Pregnant and lactating women: Lack of safety data, potential fetal or infant risks are unacceptable.

Simultaneous use of potent OATP inhibitors (such as cyclosporine) may significantly increase Elafibronor blood concentrations and increase the risk of liver toxicity.