Active Ingredient: Elafibranor
Elafibranor is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 80 milligrams elafibranor, once daily.
Before initiating elafibranor:
The recommended dosage of elafibranor is 80 mg taken orally once daily with or without food.
Administer elafibranor at least 4 hours before or 4 hours after administering the bile acid sequestrant, or at as great an interval as possible.
No dosage adjustment for patients 65 years of age and older is necessary. However, because of limited clinical experience with elafibranor in patients older than 75 years old, closer monitoring of adverse events in patients older than 75 years is recommended.
To be taken with or without food.
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