Lucius LuciSelade Seladelpar 10mg

Product Information

• Product name: LuciSelade Seladelpar 10mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Seladelpar
• Current strength: 10mg
• SKU: LU-ITEM-11
• Site category: cholangitis, other cancer

Product Summary

LuciSelade Seladelpar 10mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Seladelpar is the active ingredient used for this product page. Public prescribing information for Seladelpar was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-delta (δ) agonist. However, the mechanism by which seladelpar exerts its therapeutic effects in patients with PBC is not well understood. Pharmacological activity that is potentially relevant to therapeutic effects includes inhibition of bile acid synthesis through activation of PPARδ, which is a nuclear receptor expressed in most tissues, including the liver.

Reference Indications

Seladelpar is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. This indication is approved under accelerated approval based on a reduction of alkaline phosphatase (ALP) . Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Reference Dosage and Administration

Recommended dosage of Seladelpar is 10 mg orally once daily. Administer Seladelpar with or without food.

With this 10mg product, that corresponds to 1 x 10mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Fractures : Consider the risk of fracture in patients treated with Seladelpar. Monitor bone health according to current standards of care. Liver Test Abnormalities : Obtain baseline clinical and laboratory liver assessments prior to starting Seladelpar and monitor during treatment. Interrupt or discontinue Seladelpar if the liver tests worsen. Biliary Obstruction : Avoid use in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt Seladelpar and treat as clinically indicated. Consider the risk of fracture in the care of patients treated with Seladelpar and monitor bone health according to current standards of care. Transaminase levels returned to pretreatment levels upon Seladelpar discontinuation. Seladelpar 10 mg once daily did not show a similar pattern for increases in transaminase levels .

Common Adverse Reactions and Monitoring

Seladelpar or placebo was administered in combination with UDCA in 94% of patients and as monotherapy in 6% of patients who were unable to tolerate UDCA. Adverse Reaction Occurring in greater than or equal to 5% of patients in the Seladelpar treatment arm and at an incidence greater than or equal to 1% higher than in the placebo arm. Baseline bone mineral density was not obtained. The median time to fracture after receiving Seladelpar was 295 days (range: 89–349).

Drug Interactions and Special Populations

Probenecid : Avoid concomitant use. Strong CYP2C9 Inhibitors : Monitor for adverse effects. Dual Moderate CYP2C9 and Moderate to Strong CYP3A4 Inhibitors : Monitor for adverse effects. CYP2C9 Poor Metabolizers using Moderate to Strong CYP3A4 Inhibitors : Monitor for adverse effects. Dual or Multiple Clinical Inhibitors of Drug Transporters OATP1B1, OATP1B3, and BCRP : Monitor for adverse effects. Rifampin : Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin. Bile Acid Sequestrants : Administer at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Table 2: Clinically Significant Interactions Affecting Seladelpar Concomitant Drug or Class Potential Effect on Seladelpar Exposure ↑ = Increase, ↓ = Decrease.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Livdelzi public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.