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Elafibranor, as a PPAR dual subtype agonist, significantly reduces bile acid production and alleviates cholestasis by regulating liver lipid metabolism, inflammation and fibrosis.
1. Generic name: Elafibranor (Elafibranor)
2. Trade name: IQIRVO®
For the treatment of primary biliary cholangitis (PBC), it needs to be used in combination with ursodeoxycholic acid (UDCA) in adult patients with insufficient response to UDCA, or as a single drug treatment in patients with UDCA intolerance.
80 mg, tablets
1. Active ingredient: Elafibranol (80 mg/tablet).
2. Excipients include: Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, etc.
1. Recommended dosage: Take 80 mg orally once a day, with food or on an empty stomach.
2. Treatment of missed doses: If you miss a dose, take it within 8 hours; skip the dose if it exceeds 8 hours.
3. Combined use of bile acid binding resin: It needs to be taken at least 4 hours apart.
1. Muscle damage: For new or worsening myalgia or myopathy, treatment needs to be interrupted and the dose reduced to 50 mg once daily for the first time.
2. Abnormal liver function: Treatment needs to be interrupted when ALT/AST ≥ 5 times ULN or hepatitis symptoms appear.
3. Renal insufficiency: No dosage adjustment is required.
1. Myalgia, myopathy and pregnancy status need to be assessed before treatment.
2. Avoid grapefruit and Seville orange products.
3. When combined with HMG-CoA reductase inhibitors (such as statins), symptoms of myopathy need to be monitored.
1. Pregnancy: Contraindicated. Effective contraception is required during treatment and 3 weeks after discontinuation of medication.
2. Lactation period: Breastfeeding is prohibited during treatment and 3 weeks after the last dose.
3. Elderly people (≥65 years old): No dose adjustment is required, but close monitoring is required.
1. Common (≥5%) include: Weight gain (23%), diarrhea (11%), abdominal pain (11%), nausea (11%), vomiting (11%), joint pain (8%), constipation (8%), myalgia (7%), and fracture (6%).
2. Serious adverse reactions include:Myolysis, drug-induced liver injury, and allergic reactions.
There are no clear contraindications, but it is absolutely contraindicated during pregnancy.
1. Hormonal contraceptives: It is necessary to switch to non-hormonal contraception or add a barrier method.
2. Rifampicin: It may reduce the efficacy, so ALP and bilirubin need to be monitored.
3. Bile acid sequestrants: Need to be taken 4 hours apart.
1. Store in the original bottle, protected from moisture and light.
2. Store at room temperature (15-30℃).