Elafibror, as a dual subtype agonist of PPAR, significantly reduces bile acid production and alleviates bile stasis by regulating liver lipid metabolism, inflammation, and fibrosis.

1、 Drug name

1. Common name: Elafiber

2. Product Name: IQIRVO ®

2、 Indications

Used for the treatment of primary biliary cholangitis (PBC), it should be used in combination with ursodeoxycholic acid (UDCA) for adult patients with insufficient response to UDCA, or as monotherapy for UDCA intolerant patients.

3、 Specifications and characteristics

80mg, tablet

4、 Main components

1. Active ingredient: Elafiprono (80mg/tablet).

2. Accessories include colloidal silica, cross-linked carboxymethyl cellulose sodium, magnesium stearate, etc.

5、 Usage and dosage

1. Recommended dosage: Take 80mg orally once a day, which can be taken with food or on an empty stomach.

2. Omission treatment: If missed, make up for it within 8 hours; Skip the dose if it exceeds 8 hours.

3. Bile acid binding resin combination: It should be taken at least 4 hours apart.

6、 Dose adjustment

1. Muscle injury: For newly developed or aggravated muscle pain or myopathy, treatment should be interrupted and the initial dose should be reduced to 50 milligrams once daily.

2. Abnormal liver function: Treatment should be interrupted when ALT/AST is ≥ 5 times ULN or when symptoms of hepatitis appear.

3. Renal insufficiency: No need to adjust dosage.

7、 Medication precautions

1. Before treatment, it is necessary to evaluate muscle pain, muscle disease, and pregnancy status.

2. Avoid grapefruit and Seville orange products.

3. The combination of HMG CoA reductase inhibitors (such as statins) requires monitoring of myopathy symptoms.

8、 Medication for special populations

1. Pregnancy period: Prohibited, effective contraception is required during treatment and 3 weeks after discontinuation.

2. Breastfeeding period: Breastfeeding is prohibited during the treatment period and for 3 weeks after the last dose.

3. Elderly individuals (≥ 65 years old): No dose adjustment is required, but close monitoring is necessary.

9、 Adverse reactions

1. Common symptoms (≥ 5%) include weight gain (23%), diarrhea (11%), abdominal pain (11%), nausea (11%), vomiting (11%), joint pain (8%), constipation (8%), muscle pain (7%), and fractures (6%).

2. Serious adverse reactions include muscle dissolution, drug-induced liver injury, and allergic reactions.

10、 Contraindications

There are no clear contraindications, but it is absolutely prohibited during pregnancy.

11、 Drug interactions

1. Hormonal contraceptive pills: Non hormonal contraception or barrier therapy should be used instead.

2. Rifampicin: may reduce efficacy, ALP and bilirubin need to be monitored.

3. Bile acid chelator: It should be taken every 4 hours.

12、 Storage method

1. Store in original bottle, moisture-proof and light proof.

2. Store at room temperature (15-30 ℃).

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