Elafibranor Application Scope

Elafibranor (Iqirvo) is indicated for the treatment of:

Primary Biliary Cholangitis (PBC) in adults:
- In combination with ursodeoxycholic acid (UDCA) in patients with an inadequate response to UDCA.
- As monotherapy in patients unable to tolerate UDCA.

This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Continued approval may be contingent upon verification of clinical benefit in confirmatory trials.

Characteristics

Ingredients:
- Active Ingredient: Elafibranor
- Chemical Formula: C₂₂H₂₄O₄S
- Molecular Weight: 384.14 g/mol
- Mechanism of Action: Dual peroxisome proliferator-activated receptor (PPAR) α/δ agonist, believed to work by inhibiting bile acid synthesis through activation of PPAR-alpha and PPAR-delta.
Properties: Elafibranor is a dual peroxisome proliferator-activated receptor (PPAR) α and δ agonist, primarily developed for the treatment of primary biliary cholangitis (PBC).
Packaging Specification: Supplied in child-resistant bottles containing 30 tablets.
Storage:
- Store at room temperature between 15°C to 30°C (59°F to 86°F).
- Keep in the original package to protect from moisture and light.
Expiry Date: Refer to the packaging for the expiration date.
Executive Standard: Approved under FDA regulations.
Approval Number: FDA approval granted in June 2024
Date of Revision: Refer to the latest prescribing information for revision dates.
Manufacturer: Ipsen Biopharmaceuticals, Inc.

Guidelines for the Use of Elafibranor

Dosage and Administration:
- Recommended Dosage: 80 mg taken orally once daily, with or without food.
- Administration with Bile Acid Sequestrants: Administer Elafibranor at least 4 hours before or 4 hours after taking a bile acid binding sequestrant, or at as great an interval as possible.
Adverse Reactions:

Common side effects include:
- Myalgia, myopathy, and rhabdomyolysis.
- Fractures.
- Drug-induced liver injury.
- Hypersensitivity reactions.
Contraindications: Unknown.
Precautions:
- Muscle-related Issues: Assess for myalgia and myopathy before initiating treatment; monitor during treatment.
- Fracture Risk: Monitor bone health according to standard care.
- Embryo-fetal Toxicity: Verify negative pregnancy test before initiating in females of reproductive potential.
- Liver Injury: Monitor liver function tests; interrupt treatment if liver tests worsen.
- Hypersensitivity Reactions: Monitor for signs; discontinue if severe reactions occur.
- Biliary Obstruction: Avoid use in patients with complete biliary obstruction.

Interactions

Drug Interactions:
Hormonal Contraceptives: Elafibranor may reduce the effectiveness of hormonal contraceptives. Use non-hormonal methods during treatment and for at least 3 weeks after the last dose.
HMG-CoA Reductase Inhibitors (Statins): Increased risk of myopathy; monitor for muscle-related symptoms.
Rifampin: May reduce Elafibranor exposure; monitor liver enzymes if co-administered.
Bile Acid Sequestrants: May reduce Elafibranor absorption; administer Elafibranor at least 4 hours before or after these agents.

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.