Elafibranor is a peroxisome proliferator-activated receptor (PPAR) agonist that improves liver function parameters by activating PPAR receptors.

Precautions for Administration of Elafibranor (Elafibranor)

Precautions for Use in Special Populations

(1) Elderly Patients: No dosage adjustment is required for patients aged ≥ 65 years, but enhanced monitoring of adverse reactions is necessary for patients aged over 75 years.

(2) Pregnant Women: Elafibranor may cause fetal harm. It is necessary to confirm that the patient is not pregnant before medication, and effective contraceptive measures should be taken during treatment.

(3) Lactating Women: Breastfeeding is not recommended during treatment and within 3 weeks after the last dose.

Risk of Muscle-Related Adverse Reactions

(1) Elafibranor may cause myalgia, myopathy, and rhabdomyolysis, and the risk is increased especially when used concomitantly with HMG-CoA reductase inhibitors (statins).

(2) Before medication, it is necessary to assess symptoms of myalgia or myopathy, and regular monitoring should be conducted during treatment.

Fracture Risk

(1) In clinical trials, 6% of patients treated with elafibranor experienced fractures, while no fractures were reported in the placebo group.

(2) Bone health should be monitored and maintained in accordance with current standards.

Drug Interactions

(1) Hormonal Contraceptives: Elafibranor may reduce the efficacy of hormonal contraceptives. It is recommended to switch to non-hormonal contraceptive methods or add barrier contraception.

(2) HMG-CoA Reductase Inhibitors: The risk of myopathy is increased, so enhanced monitoring is required.

(3) Rifampicin: Rifampicin may reduce the efficacy of elafibranor, so it is necessary to monitor biochemical responses.

(4) Bile Acid Sequestrants: The administration of elafibranor and bile acid sequestrants should be separated by at least 4 hours.

Medication Monitoring Requirements for Elafibranor (Elafibranor)

Pre-Treatment Assessment

(1) Baseline Examinations: Liver function (ALT, AST, TB, ALP), creatine phosphokinase (CPK), renal function, and pregnancy test (for women of childbearing age).

(2) Assessment of Muscle Symptoms: Conduct a detailed inquiry about symptoms such as myalgia and muscle weakness.

(3) Assessment of Bone Health: Evaluate risk factors for fractures.

(4) Assessment of Concomitant Medications: Pay special attention to the use of statins.

Routine Monitoring

(1) Liver Function Monitoring: Regularly test ALT, AST, TB, and ALP during treatment.

(2) Muscle Symptom Monitoring: Pay attention to new or worsening symptoms such as muscle pain and weakness; test CPK if necessary.

(3) Fracture Monitoring: Pay attention to symptoms of new fractures or bone pain.

(4) Adverse Reaction Monitoring: Focus on common adverse reactions including weight gain (23%), diarrhea (11%), abdominal pain (11%), nausea (11%), vomiting (11%), arthralgia (8%), constipation (8%), muscle pain (7%), and fracture (6%).

Special Monitoring

(1) Drug-Induced Liver Injury: If liver function deterioration or hepatitis symptoms (such as jaundice, right upper abdominal pain, and eosinophilia) occur, treatment should be discontinued.

(2) Allergic Reactions: If allergic symptoms such as rash occur, decide whether to discontinue the drug based on the severity.

(3) Biliary Obstruction: If biliary obstruction is suspected, treatment should be discontinued and clinical evaluation conducted.