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ALIMENTARY TRACT AND METABOLISM › BILE AND LIVER THERAPY › BILE THERAPY › Other drugs for bile therapy
elafibranor
A05AX06
Adult Dosing
- Primary biliary cholangitis (PBC): 80 mg once daily, administered orally in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established.
Indications
- Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
Mechanism of Action
- Dual peroxisome proliferator-activated receptor (PPAR) alpha/delta agonist; activation of PPAR-alpha and PPAR-delta modulates bile acid synthesis, inflammation, and lipid metabolism, reducing cholestasis and hepatic fibrosis.
Contraindications
- Known hypersensitivity to elafibranor or any of its excipients
- Cirrhosis with portal hypertension or decompensated liver disease
Adverse Reactions
- Weight increased
- Diarrhea
- Abdominal pain
- Nausea
- Vomiting
- Arthralgia
- Myalgia
- Fractures
Drug Interactions
- Inhibitors or inducers of CYP enzymes and transporters may affect elafibranor exposure, though specific strong clinical interactions are managed per monitoring guidelines
- Co-administration with OATP1B1/1B3 inhibitors may increase systemic exposure of elafibranor active metabolite
Curated Content: Needs Vetting Before Put to Clinical Use