Elafibranor
IQIRVO
What it isAn oral dual PPAR alpha/delta agonist for primary biliary cholangitis with inadequate response to ursodiol.
Why this oneUnlike delta-selective seladelpar, its dual PPAR action lowers alkaline phosphatase after ursodiol failure.
What limits itApproval is accelerated on that biochemical surrogate; monitor liver tests and muscle symptoms. Fractures, fetal harm, and decompensated cirrhosis matter.
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Primary biliary cholangitis (with UDCA; monotherapy if UDCA-intolerant) | Adults | 80 mg QD | 80 mg QD | 80 mg/day |
Renal No adjustment needed
Hepatic Mild (Child-Pugh A): no adjustment; not recommended in decompensated cirrhosis; consider discontinuing if progresses to Child-Pugh B or C
Instructions
- Take with or without food
- Before starting: evaluate for muscle pain/myopathy and verify females of reproductive potential are not pregnant
- Take ≥4 h before or ≥4 h after bile acid sequestrants (or as far apart as possible)
Cautions
- Myalgia, myopathy, rhabdomyolysis: assess before starting; consider periodic exam/CPK; interrupt for new or worsening muscle injury; higher risk with concomitant fibrates (PPAR-alpha agonists) or statins
- Fractures (6% vs 0% placebo): monitor bone health per standard of care
- Fetal/newborn developmental harm: avoid ethinyl estradiol-containing hormonal contraceptives — use alternative contraception during treatment and 3 weeks after
- Drug-induced liver injury: baseline labs, monitor; interrupt if liver tests worsen or clinical hepatitis; consider permanent discontinuation if worsening on rechallenge
- Hypersensitivity reactions: interrupt (mild/moderate) or permanently discontinue (severe or recurrent)
- Biliary obstruction: avoid use in complete biliary obstruction; interrupt if obstruction suspected
Adverse reactions
- Weight gain
- Diarrhea, abdominal pain, nausea, vomiting, constipation, GERD, dry mouth
- Arthralgia, muscle injury, fracture
- Weight loss, rash
Pregnancy May cause fetal harm (animal data at ≤ human exposure); verify not pregnant before starting; pregnancy registry available
Lactation Do not breastfeed during treatment and for 3 weeks after last dose
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Elafibranor ballicule
