Elafibranor Disease Interactions

The safety and efficacy of elafibranor have not been established in patients with decompensated cirrhosis. Use of elafibranor is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). Monitor patients with cirrhosis for evidence of decompensation. Consider discontinuing elafibranor if the patient progresses to moderate or severe liver dysfunction (Child-Pugh B or C). No dose adjustment is recommended in patients with mild to moderate liver dysfunction (Child-Pugh A). Avoid use in patients with complete biliary obstruction.

Myopathy or myalgia (with or without CPK elevations) and rhabdomyolysis have been reported in patients treated with elafibranor. Assess patients for myalgia and myopathy prior to starting elafibranor. Consider periodic assessment (clinical exam, CPK measurement) during treatment with elafibranor, especially in patients with signs and symptoms of new onset or worsening of muscle pain or myopathy. Interrupt therapy with elafibranor if signs/symptoms of muscle injury occur.