Precautions of Seladelpar

1. Fractures

Fractures occurred in 4% of patients receiving seladelpar, compared with no fractures in patients receiving placebo.

When caring for patients receiving seladelpar, consider the risk of fracture and monitor bone health according to current standards of care.

2. Abnormal Hepatic Laboratory Tests

Dose-related elevations in serum transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) greater than 3 times the upper limit of normal (ULN) were observed in PBC patients receiving seladelpar 50 mg once daily (5 times the recommended dose) and 200 mg (20 times the recommended dose). Transaminase levels returned to pretreatment levels after discontinuation of seladelpar. Seladelpar 10 mg once daily did not show a similar pattern of transaminase elevations.

Obtain baseline clinical and laboratory evaluations at initiation of seladelpar therapy and monitor thereafter according to routine patient management. If liver function tests (ALT, AST, total bilirubin [TB], and/or alkaline phosphatase [ALP]) worsen, or if the patient develops signs and symptoms consistent with clinical hepatitis (e.g., jaundice, right upper quadrant pain, eosinophilia), interrupt seladelpar therapy. If liver function tests worsen again after restarting seladelpar, consider permanent discontinuation.

3. Biliary Obstruction

Avoid use of seladelpar in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt seladelpar and treat as clinically indicated.