Lucius lucielafib Elafibranor 80mg

Product Information

• Product name: lucielafib Elafibranor 80mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Elafibranor
• Current strength: 80mg
• SKU: LU-ITEM-47
• Site category: cholangitis, other cancer

Product Summary

lucielafib Elafibranor 80mg 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

Elafibranor is the active ingredient used for this product page. Public prescribing information for Elafibranor 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

Elafibranor and its main active metabolite GFT1007 are peroxisome proliferator-activated receptor (PPAR) agonists, both of which activate PPAR-alpha, PPAR-gamma, and PPAR-delta in vitro. However, the mechanism by which elafibranor 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 PPAR-alpha and PPAR-delta.

Reference Indications

Elafibranor 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 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 is 80 mg orally once daily with or without food.

With this 80mg product, that corresponds to 1 x 80mg 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

Myalgia, Myopathy, and Rhabdomyolysis : Assess for muscle pain and myopathy prior to Elafibranor initiation. Consider periodic assessment (clinical exam, CPK measurement). Interrupt Elafibranor if there is new onset or worsening of muscle injury, or muscle pain. Fractures: The risk of fracture should be considered in the care of patients treated with Elafibranor. Apply current standards of care for assessing and maintaining bone health. Adverse Effects on Fetal and Newborn Development : May cause fetal harm. Verify that a female of reproductive potential is not pregnant prior to initiating Elafibranor. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Common Adverse Reactions and Monitoring

The safety of Elafibranor is based on Study 1 consisting of 161 patients who were randomized to receive Elafibranor 80 mg (n=108) or placebo (n=53) once daily with a median duration of exposure during the double-blind period of 62 weeks (inter quartile range: 52, 84) . Elafibranor or placebo was administered in combination with UDCA in 95% of patients and as monotherapy in 5% of patients who were unable to tolerate UDCA. The most common adverse reaction leading to treatment discontinuation was increased CPK (4%).

Drug Interactions and Special Populations

Hormonal Contraceptives: Switch to effective non-hormonal contraceptives or add a barrier method when using hormonal contraceptives and for at least 3 weeks after last dose. HMG-CoA Reductase Inhibitors : Monitor for signs and symptoms of muscle injury. ( 5.1 , 7.1 ) Rifampin: Monitor the biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during Elafibranor treatment. Bile Acid Sequestrants: Administer at least 4 hours before or 4 hours after taking a bile acid binding sequestrant, or at as great an interval as possible. Table 3: Clinically Significant Interactions Affecting Other Drugs Hormonal Contraceptives Clinical Impact Elafibranor is a weak CYP3A4 inducer .

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: IQIRVO 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.