80mg*30 film-coated tablets

Therapeutic Indications

For the treatment of Primary Biliary Cholangitis (PBC) in adults:
➤ In combination with Ursodeoxycholic Acid (UDCA) for patients with inadequate response to UDCA;
➤ As monotherapy for patients intolerant to UDCA.

Efficacy

➤ Dual activation of PPARα/δ receptors, regulating bile acid homeostasis, reducing bile toxicity, and improving cholestasis;
➤ Reduces levels of Alkaline Phosphatase (ALP), bile acid precursor C4, and FGF-19;
➤ 51% of patients achieved cholestasis response (ALP <1.67×ULN, TB ≤ULN, and ALP reduction ≥15%) at Week 52.

Pharmaceutical Form & Strength

➤ 80 mg elafibranor per film-coated tablet;
➤ Round, orange, film-coated tablets;
➤ 30 tablets per bottle.

Dosage and Administration

Oral administration, once daily, 80 mg per dose, or as prescribed.

Special Warnings & Precautions

➤ Hepatotoxicity: Monitor liver enzymes (e.g., ALT, bilirubin) before/during treatment; interrupt treatment if abnormalities occur.
➤ Muscle Injury: Monitor Creatine Phosphokinase (CPK), especially when co-administered with statins.
➤ Pregnancy Contraindication: Contraindicated in pregnant women or women of childbearing potential without contraception (teratogenic risk).
➤ Lactation: Avoid breastfeeding during treatment and for ≥3 weeks after discontinuation.
➤ Severe Hepatic Impairment: Not recommended for Child-Pugh C patients.

Storage Conditions

No special storage conditions required (room temperature storage).