Seladelpar Application Scope

Seladelpar is indicated for the treatment of primary biliary cholangitis (PBC) in adults, either:

In combination with ursodeoxycholic acid (UDCA) in patients with an inadequate response to UDCA, or
As monotherapy in patients unable to tolerate UDCA.

Characteristics

Ingredients: Each capsule contains seladelpar lysine equivalent to 10 mg of seladelpar base.
Properties: It is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, which helps regulate lipid metabolism and inflammation.
Packaging Specification: Capsules are 10 mg, opaque, hard gelatin, size 1, with a light gray body and dark blue cap, printed with “CBAY” on the cap and “10” on the body.
Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F)
Expiry Date: Shelf life is 48 months from the date of manufacture when stored as recommended.
Executive Standard: Approved under FDA NDA 217899
Approval Number: NDA 217899
Date of Revision: August 14, 2024
Manufacturer: Gilead Sciences, Inc.

Dosage and Administration:
- Recommended dosage is 10 mg orally once daily, with or without food.
- If co-administered with bile acid sequestrants, administer Seladelpar at least 4 hours before or after the sequestrant.
Adverse Reactions:
- Common (≥5%): Headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), dizziness (5%).
- Serious: Increased risk of bone fractures, liver test abnormalities, and biliary obstruction.
Contraindications: Unknown.
Precautions:
- Bone Fractures: Monitor bone health; fractures reported in 4% of patients.
- Liver Function: Monitor liver enzymes; discontinue if significant elevations occur.
- Biliary Obstruction: Avoid use in patients with complete biliary obstruction.

Drug Interactions:
Bile Acid Sequestrants: Administer Livdelzi at least 4 hours before or after these agents.
BCRP Inhibitors: Monitor for increased Livdelzi levels and potential adverse effects.
CYP3A4 Inhibitors: Use caution; may increase Livdelzi exposure.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.