

Another NameIqirvo
IndicationsIt is indicated for the treatment of adult patients with primary biliary cholangitis who have an inadequate response to or intolerance of ursodeoxycholic acid.
Reg No.02 L 1297/25
Inspection NO.428-25

This medication produced by Lucius Pharmaceuticals, as a novel PPAR agonist, has shown good efficacy in improving cholestasis-related biochemical indicators and provides a valuable treatment option for specific PBC patients.
Below is an overview of the main information about this medication:
The main ingredient is elafibranor, and its active metabolite is GFT1007.
Indicated for adult patients with primary biliary cholangitis (PBC) who have an inadequate response to or intolerance of ursodeoxycholic acid (UDCA).
The recommended dose is 80 mg orally once daily, which can be taken with or without food.Reference article: Dosage and Administration of Elafibranor
Women of childbearing age must use effective contraception.
It is not recommended for patients with decompensated cirrhosis.
No dosage adjustment is required for elderly patients.
Information on drug overdose is unknown. If an overdose occurs, medical assistance should be sought immediately.
Store in the original packaging at 15°C–30°C, protected from moisture and light.
Elafibranor and its metabolite GFT1007 are metabolized by multiple enzymes in the body. At steady state, the exposure of GFT1007 is approximately 3.2 times that of elafibranor.
FDA,2024.06