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elafibranor (Iqirvo)
Indications:
- treatment of primary biliary cholangitis combination with ursodeoxycholic acid
- monotherapy in patients unable to tolerate ursodeoxycholic acid
Contraindications:
- pregnancy
- not recommended in patients who have or develop decompensated cirrhosis
Dosage:
- 80 mg PO QD with or without food
- 80 mg Oral Tablet
- no specific geriatric dosing recommended
- no dosage adjustment for renal failure
Adverse effects:
- myalgia, myopathy, rhabdomyolysis
- increased risk of fractures
- fetal toxicity
- > 5%
- weight gain/ weight loss, diarrhea, abdominal pain, nausea/vomiting, arthralgia, constipation, GERD, dry mouth, rash
Drug interactions:
- weak CYP3A4 inducer
Mechanism of action:
- peroxisome proliferator-activated receptor agonist (PPAR agonist)
- elafibranor & its active metabolite activate PPAR-alpha, PPAR-gamma, & PPAR-delta
- reduces serum alkaline phosphatase
- signaling pathway for PPAR-delta includes FGF21-dependent downregulation of CYP7A1, the key enzyme for synthesis of bile acids from cholesterol
* improvement in survival or prevention of liver failure has not been demonstrated
General
receptor agonist
gastrointestinal agent
Database Correlations
PUBCHEM correlations
References
- Kowdley KV, Bowlus CL, Levy C et al
Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis.
N Engl J Med. 2024 Feb 29;390(9):795-805
PMID: 37962077 Clinical Trial.
https://www.nejm.org/doi/10.1056/NEJMoa2306185
- HIGHLIGHTS OF PRESCRIBING INFORMATION
IQIRVO (elafibranor) tablets, for oral use
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