Although Pemafibrate is a selective PPARα modulator, it is not suitable for all patients with dyslipidemia. Patients with severe hepatic impairment and gallbladder disease require special assessment before use, and in some cases it should be contraindicated or used with caution.

Patients with Severe Hepatic Impairment

Pemafibrate is contraindicated in patients with severe hepatic impairment. When liver function is severely impaired, drug metabolism and clearance are reduced, which may increase the burden on the liver.

The drug itself may cause elevated liver enzymes, and in patients with severe liver disease it is difficult to distinguish drug-induced liver injury from progression of the underlying disease after administration.

Liver function should be tested before treatment, including ALT, AST, bilirubin, etc.; and rechecked regularly during treatment.

If fatigue, loss of appetite, jaundice, dark urine, or right upper abdominal discomfort occurs, the drug should be stopped immediately and medical attention sought.

For patients with mild to moderate hepatic impairment, the decision on whether to use the drug should be made by the doctor after assessing the risks and benefits, with dose reduction and enhanced monitoring if necessary.

Patients with Gallbladder Disease

Available information suggests that Pemafibrate may increase the risk of gallstones or gallbladder-related events, and it should be used with caution in patients with a history of gallbladder disease.

Patients with a history of gallstones, cholecystitis, biliary obstruction, or cholecystectomy should inform the doctor before treatment and have their gallbladder status assessed.

During treatment, if right upper abdominal pain, nausea, vomiting, fever, or jaundice occurs, biliary events should be suspected and medical attention sought promptly.

For patients with active gallbladder disease or unexplained right upper abdominal symptoms, treatment should not be started hastily.

For those requiring long-term treatment, gallbladder status may be assessed periodically in conjunction with examinations such as abdominal ultrasound.

Other Considerations

Severe renal impairment, breastfeeding women, and other groups also require assessment according to the instructions.

Contraindications and precautions cannot be determined on one's own and should be comprehensively decided by the doctor based on lipid levels, concomitant medications, and past medical history.

Patients should not stop the drug on their own out of concern about contraindications, nor should they purchase and take the drug on their own when contraindications exist.