Seladelpar lysine dihydrate: clinical use

Prescribing considerations

• Confirm hepatic status and any previous decompensation before initiation.
• Use is not recommended in current or previous decompensated cirrhosis; monitor compensated cirrhosis for progression.
• Evidence is unavailable in end-stage renal disease requiring dialysis and limited in very elderly adults.
• Seladelpar is subject to additional monitoring; report suspected adverse reactions through the Yellow Card scheme.

Contraindications and cautions

• Hypersensitivity to seladelpar or any excipient
• Complete biliary obstruction

Monitoring

• Baseline clinical assessment and liver tests, including ALT, AST, bilirubin and alkaline phosphatase
• Subsequent liver tests according to clinical practice
• Clinical evidence of hepatitis or hepatic decompensation, particularly in cirrhosis
• Interrupt treatment if liver tests worsen or clinical hepatitis develops; reassess continuation if abnormalities recur after restarting

Clinical pharmacology

Seladelpar is a potent selective PPAR-delta agonist. It reduces bile-acid synthesis through FGF21-associated downregulation of CYP7A1. It is highly protein-bound, primarily metabolised through CYP2C9 with lesser CYP2C8 and CYP3A4 involvement, and eliminated mainly in urine as inactive metabolites.

Formulation and product differences

• The product is a hard capsule with a gelatine shell.
• Capsule excipients include mannitol and butylated hydroxytoluene; check the complete excipient list when allergy or intolerance is relevant.

Capsule

Route: Oral

Strengths: 10 mg