Dosage of Elafibranor

1. Recommended Assessments Before Initiating Elafibranor Treatment

Before starting elafibranor treatment:

Assess for muscle pain or myopathy.

Confirm that females of reproductive potential are not pregnant before initiating elafibranor treatment.

2. Recommended Dosage and Administration Method

The recommended dosage of elafibranor is 80 mg, taken orally once daily, either with food or on an empty stomach.

3. Dosage Administration Adjustments for Bile Acid Sequestrants

Administer elafibranor at least 4 hours before or at least 4 hours after taking bile acid sequestrants, or allow for the longest possible interval between administrations if feasible.

FDA，2024.06