Elafibranor

FDA label

Read the full label on DailyMed ↗

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)

Available strengths

• tab 80 mg

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