----------------------- WARNINGS AND PRECAUTIONS------------------------
• Patients should be advised to report promptly any unexplained and/or persistent muscle pain, tenderness, or weakness. LIPTRUZET should be discontinued immediately if myopathy is diagnosed or suspected. (5.1)
• Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain CYP3A4 inhibitors, fibric acid derivatives, and cyclosporine. Predisposing factors include advanced age (>65), uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported. (5.1, 8.5)
• Liver enzyme abnormalities: Persistent elevations in hepatic transaminase can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter. (5.2)