seladelpar

Siladepa, as a new mechanism drug, mainly relieves cholestasis 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 (Seladelpar)

2. Trade name: LIVDELZI®

2. Indications

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

2. In combination with ursodeoxycholic acid (UDCA), it is suitable for patients with poor efficacy of UDCA alone;

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

3. Specifications and properties

10mg capsules.

IV. Main ingredients

1. Active ingredient: seladelparlysine;

2. Excipients: Hydroxybutyltoluene, colloidal silicon dioxide, croscarmellose sodium, etc.

5. Usage and dosage

1. Conventional dose of :10 mg orally, once a day, before or after a meal;

2. Bile acids U200c combined with resin: It needs to be taken at least 4 hours apart;

3. Treatment of missed doses : If you miss a dose, you should take it as soon as possible; if it is close to the next dose time, skip this dose.

VI. Dose adjustment

1. Renal insufficiency : No adjustment is required from mild to severe, end-stage renal disease (dialysis) data is insufficient;

2. Liver insufficiency : Child-Pugh A grade does not require adjustment, Child-Pugh B/C grade or decompensated cirrhosis is not recommended;

3. CYP2C9 poor metabolizer :Strengthened monitoring is required when combined with moderate and strong CYP3A4 inhibitors.

7. Medication precautions

1. Effect of diet : Food does not affect absorption;

2. Treatment of vomiting : If you vomit after taking the medicine, no supplement is needed. Take;

3. Liver function monitoring :Regular detection of ALT, AST and other indicators before and during treatment;

4. Fracture risk :4% of patients report fractures, and bone health needs to be monitored.

8. Medication for special groups

1. U200c during pregnancy: Animal experiments show the risk of fetal growth restriction. It is necessary to weigh the pros and cons during pregnancy and report pregnancy safety research (1-800-445-32 35);

2. U200c during lactation:The safety is unknown, it is recommended to suspend breastfeeding;

3. U200c for the elderly (≥65 years old):No dose adjustment is required, but close monitoring is required for those over 75 years old.

9. Adverse reactions

1. Common (≥5%) include: Headache (8%), abdominal pain (7%), nausea (6%), bloating (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 in patients with complete biliary obstruction.

11. Drug interactions

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

2. The interval needs to be adjusted : Bile acid binding resin (such as cholestyramine);

3. Monitoring needs : Rifampicin may reduce the efficacy of the drug, and ALP levels need to be monitored.

12. Storage method

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