Seladelpar

FDA label

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Renal Mild, moderate, or severe: no adjustment (same as normal renal function); ESRD on dialysis not studied

Hepatic Mild (Child-Pugh A): no adjustment. Not recommended in decompensated cirrhosis (ascites, variceal bleeding, encephalopathy); monitor cirrhotic patients for decompensation and consider discontinuing if progression to Child-Pugh B or C

Instructions

• Take with or without food
• Take at least 4 h before or 4 h after bile acid sequestrants (or at as great an interval as possible)

Cautions

• Fractures — occurred in 4% of treated patients (vs 0 placebo); consider fracture risk and monitor bone health per standards of care
• Liver test abnormalities — dose-related transaminase elevations >3x ULN at supratherapeutic doses; obtain baseline liver assessments, monitor; interrupt if ALT/AST/bilirubin/ALP worsen or clinical hepatitis signs; consider permanent discontinuation if worsening recurs on rechallenge
• Biliary obstruction — avoid in complete biliary obstruction; interrupt if obstruction suspected
• CYP2C9 poor metabolizers taking a moderate-strong CYP3A4 inhibitor: increased seladelpar exposure expected — monitor more frequently for adverse reactions

Adverse reactions

• Most common (≥5%, > placebo): headache, abdominal pain, nausea, abdominal distension, dizziness
• Fractures 4%
• eGFR decline ≥25% in 10% (vs 2% placebo); stabilized/returned toward baseline on continued treatment
• Less common (<5%): dyspepsia, rash, alopecia, anemia, cough

Pregnancy Insufficient human data; no malformations or embryo-fetal survival effects in rats/rabbits up to 176x/49x recommended exposure; reduced fetal growth (with maternal toxicity) in rabbits at 49x

Lactation No data on presence in human or animal milk, infant effects, or milk production; weigh benefits of breastfeeding against maternal need and potential infant risk