What are the precautions for Livdelzi (Seladelpar)

In clinical studies of Livdelzi (Seladelpar) in the treatment of primary cholangitis (PBC), warnings and precautions such as fractures, abnormal liver tests, and biliary obstruction have emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Fractures: Compared with patients who did not receive placebo, 4% of patients who receivedLivdelzi experienced fractures. Consider the risk of fracture in patients treated with Livdelzi and monitor bone health according to current standards of care. Allow your doctor if you experience pain or changes in your mobility.

2. Abnormal liver tests: In patients with PBC receiving 50 mg once daily (5 times higher than the recommended dose) and 200 mg once daily (20 times higher than the recommended dose), Livdelzi was associated with a dose-related increase in serum aminotransferase (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) levels exceeding 3 times the upper limit of normal (ULN). After discontinuation of Livdelzi, transaminase levels returned to pre-treatment levels. A similar pattern of elevated transaminase levels was not seen with once-daily dosing of Livdelzi.

Obtain baseline clinical and laboratory assessments at the beginning of treatment with Livdelzi and monitor based on routine patient management. Interrupt Livdelzi treatment if liver 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). If liver function tests worsen after restarting Livdelzi, consider permanently discontinuing the drug.

3. Biliary tract obstruction: Avoid using Livdelzi in patients with complete biliary obstruction.Livdelzi. If biliary obstruction is suspected, interrupt Livdelzi and treat as clinically indicated.