Seladelpar is a new-type therapeutic drug for primary biliary cholangitis (PBC), which exerts its effects by activating peroxisome proliferator-activated receptor delta (PPARδ).
Indications for Seladelpar
Main Therapeutic Uses
Seladelpar is approved for the treatment of two categories of adult patients with primary biliary cholangitis (PBC) as follows.
Combination therapy: Used in combination with ursodeoxycholic acid (UDCA), it is indicated for PBC patients with an inadequate response to UDCA.
Monotherapy: Used as monotherapy for PBC patients who cannot tolerate UDCA.
Usage Restrictions and Precautions
It is not recommended for patients with decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
It must be used under the guidance of a physician with experience in PBC treatment.
Regular monitoring of liver function indicators and bone health status is required.
Specifications and Properties of Seladelpar
Preparation Specifications
Seladelpar is an oral hard capsule preparation.
Specification: 10 mg per capsule (calculated as seladelpar free acid).
Appearance Characteristics
The capsules are opaque.
Size: Size 1 capsules.
Color: Opaque light gray capsule body and opaque dark blue capsule cap.
Marking: The capsule cap is printed with "CBAY", and the capsule body is printed with "10".
Composition
Active ingredient: 14.1 mg seladelpar lysine salt (equivalent to 10 mg seladelpar free acid).
Excipients: Butylated hydroxytoluene (BHT), colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose.
Capsule shell: Gelatin, titanium dioxide, iron oxide colorants, and FD&C Blue No. 2.
Storage Method for Seladelpar
Storage Condition Requirements
Temperature: Store at room temperature between 20°C and 25°C (68°F and 77°F).
Allowable fluctuation range: Short-term exposure to temperatures between 15°C and 30°C (59°F and 86°F) is tolerable.
Precautions: Keep in the original packaging to protect from light and avoid humid environments.
Special Handling Requirements
Child protection: Packaged with child-resistant caps; store out of the reach of children.
Moisture and damage prevention: Keep the desiccant inside the bottle intact and avoid crushing or deforming the capsules.
Expired disposal: Expired drugs should be disposed of professionally in accordance with local regulations.
