Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-δ agonist, primarily used for the treatment of adult patients with primary biliary cholangitis (PBC) who have an inadequate response to ursodeoxycholic acid (UDCA) or cannot tolerate UDCA.
What Are the Side Effects of Seladelpar?
Systemic Reactions
Headache: Incidence rate of 8%.
Dizziness: Incidence rate of 5%.
Gastrointestinal Reactions
Abdominal pain: Incidence rate of 7%.
Nausea: Incidence rate of 6%.
Abdominal distension: Incidence rate of 6%.
Abnormal Laboratory Findings
eGFR decrease ≥ 25%: Incidence rate of 10%.
Hemoglobin reduction: Incidence rate of 37%.
Lymphopenia: Incidence rate of 32%.
Serious Side Effects of Seladelpar That Require Vigilance
Liver Dysfunction
High doses (50 mg and 200 mg) may cause transaminase elevation > 3 times the upper limit of normal (ULN).
It is recommended to monitor liver function (ALT, AST, TB, ALP) regularly before and during treatment.
If liver function deterioration or clinical hepatitis symptoms (such as jaundice, right upper abdominal pain) occur, treatment should be discontinued.
Biliary Obstruction
Patients with complete biliary obstruction should avoid using this medication.
If biliary obstruction is suspected, treatment should be discontinued and appropriate management should be implemented.
Other Serious Reactions
Impact on renal function: 10% of patients experience an eGFR decrease ≥ 25%.
Allergic reactions: The incidence rate of infusion-related reactions is 7%.
Precautions for Seladelpar Administration
Contraindicated Populations
Patients allergic to any component of this product.
Pregnant women (may cause fetal harm).
Lactating women (breastfeeding should be avoided for at least 5 months after discontinuing the medication).
Medication Use in Special Populations
Hepatic impairment: No dose adjustment is required for patients with Child-Pugh Class A hepatic impairment; use in patients with decompensated cirrhosis is not recommended.
Renal impairment: No dose adjustment is required for patients with mild to moderate renal impairment; data on patients with end-stage renal disease are limited.
Elderly patients: No dose adjustment is required for patients aged ≥ 65 years; close monitoring is needed for patients aged ≥ 75 years.
Pediatric patients: The efficacy has not been established.
Important Drug Interactions
Concomitant use should be avoided: OAT3 inhibitors, strong CYP2C9 inhibitors.
Administration time adjustment is required: Bile acid sequestrants (administer at an interval of at least 4 hours).
Close monitoring is required: Rifampicin, moderate to strong dual CYP2C9/CYP3A4 inhibitors, BCRP inhibitors.
Key Patient Education Points
Recognize the early symptoms of serious side effects and report them promptly.
Take the medication strictly according to the dose prescribed by the doctor.
Consult a doctor before using this medication in combination with other drugs.
Women of childbearing age should take effective contraceptive measures.
