Seladelpar

Class
Antifibrotic agents
Subclass
PPARδ agonists
Substance name
Seladelpar lysine
Brand names
Livdelzi®
Common formulations
Capsule
Dosage and administration
Adults patients
Primary biliary cholangitis • Not responding to UDCA
•
10 mg PO daily
Taken with or without food. Administered in combination with UDCA.
Primary biliary cholangitis, if UDCA is ineffective or contraindicated
•
10 mg PO daily
Taken with or without food.
Indications for use
Labeled indications
Adults
•
Treatment of primary biliary cholangitis (not responding to UDCA)
•
Treatment of primary biliary cholangitis, if UDCA is ineffective or contraindicated
Safety risks
Contraindications
Complete biliary obstruction
•
Interrupt seladelpar if biliary obstruction is suspected.
Concomitant use of strong CYP2C9 inhibitors or OAT3 inhibitors
Warnings and precautions
Bone fracture
•
Maintain a high level of suspicion, as seladelpar has been associated with an increased risk of fractures.
Decreased serum seladelpar levels
•
Use caution in patients taking bile acid sequestrants or rifampin. Administer seladelpar either at least 4 hours before or 4 hours after taking bile acid sequestrants. Monitor ALP and bilirubin levels in patients taking rifampin.
Increased serum seladelpar levels
•
Use caution in CYP2C9 poor metabolizers taking moderate-to-strong CYP3A4 inhibitors, as well as in patients taking dual moderate CYP2C9 inhibitors and moderate-to-strong CYP3A4 inhibitors, or BCRP inhibitors.
Increased serum transaminases
•
Maintain a high level of suspicion, as seladelpar has been associated with increased serum transaminase levels. Obtain baseline clinical and laboratory assessments at initiation and monitor regularly thereafter. Interrupt seladelpar if liver tests worsen or if signs and symptoms of clinical hepatitis develop. Consider permanent discontinuation of seladelpar if liver tests continue to worsen after restarting.
Specific populations
Renal impairment
eGFR ≥ 15 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 15 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Acute or decompensated chronic liver disease
•
Do not use.
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required. Consider discontinuing if hepatic impairment progresses to Child-Pugh B or C.
Child-Pugh B (moderate)
•
Do not use.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Insufficient evidence.
Breastfeeding
Little information available on breastfeeding safety.
•
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
Bone fracture, ↑ serum creatinine, abdominal pain, dizziness, dyspepsia, skin rash, hair loss, anemia, cough, headache, nausea, abdominal distension
Unknown frequency
•
↑ serum transaminases
Interactions
Drug(s)
Check Interactions
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