As a new mechanism drug, Sirapa mainly alleviates bile stasis and inflammatory damage in the process of PBC by regulating bile acid metabolism, inhibiting inflammation, and improving liver energy metabolism.

1、 Drug name

1. Common name: Seladelpar

2. Product Name: LIVDELZI ®

2、 Indications

1. For adult patients with primary biliary cholangitis (PBC):

2. Combined with ursodeoxycholic acid (UDCA), suitable for patients with poor efficacy of UDCA monotherapy;

3. As a monotherapy, it is suitable for patients who cannot tolerate UDCA.

3、 Specifications and characteristics

10mg capsule.

4、 Main components

1. Active ingredient: Seladelalysine salt;

2. Accessories: Hydroxytoluene, colloidal silica, cross-linked carboxymethyl cellulose sodium, etc.

5、 Usage and dosage

1. Conventional dose: 10mg orally, once daily, before or after meals;

2. Bile acid binding resin combination: should be taken at least 4 hours apart;

3. Omission treatment: If missed, it should be replenished as soon as possible; If it is close to the next medication time, skip this dose.

6、 Dose adjustment

1. Renal insufficiency: mild to severe without adjustment, insufficient data for end-stage renal disease (dialysis);

2. Liver dysfunction: Child Pugh A grade does not require adjustment, Child Pugh B/C grade or decompensated cirrhosis are not recommended for use;

3. CYP2C9 weak metabolizers: Monitoring should be strengthened when combined with strong CYP3A4 inhibitors.

7、 Medication precautions

1. Dietary impact: Food does not affect absorption;

2. Vomiting treatment: If vomiting occurs after taking medication, there is no need to take additional medication;

3. Liver function monitoring: ALT, AST and other indicators should be regularly tested before and during treatment;

4. Fracture risk: 4% of patients report fractures and require monitoring of bone health.

8、 Medication for special populations

1. Pregnancy period: Animal experiments have shown the risk of fetal growth restriction. During pregnancy, it is necessary to weigh the pros and cons and report on pregnancy safety studies (1-800-445-3235);

2. Breastfeeding period: Safety unknown, it is recommended to suspend breastfeeding;

3. Elderly individuals (≥ 65 years old): No dose adjustment is required, but close monitoring is necessary for those over 75 years old.

9、 Adverse reactions

1. Common (≥ 5%) symptoms include headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%).

2. Serious adverse reactions may include elevated liver enzymes and bile duct obstruction.

10、 Contraindications

There are no clear contraindications, but it is contraindicated for patients with complete biliary obstruction.

11、 Drug interactions

1. Avoid combination use: OAT3 inhibitors (such as probenecid), strong CYP2C9 inhibitors;

2. Need to adjust interval: bile acid binding resin (such as colexamide);

3. Monitoring requirement: Rifampicin may reduce its efficacy, and ALP levels need to be monitored.

12、 Storage method

Store at room temperature (20 ° C-25 ° C), allowing short-term exposure to 15 ° C-30 ° C.

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