Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur.IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment positive anti-HMG CoA reductase antibody muscle biopsy showing necrotizing myopathy and improvement with imunosuppressive agents ( 5.2) Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use.LESCOL XL therapy should be discontinued if myopathy is diagnosed or suspected ( 5.1) Patients should be advised to report promptly any symptoms of myopathy.Advise patients to promptly report to their physician unexplained and/or persistent muscle pain, tenderness, or weakness and discontinue LESCOL XL if myopathy is diagnosed or suspected ( 5.1, 8.5, 8.7) Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with advanced age (≥ 65), uncontrolled hypothyroidism, renal impairment, and combination use with cyclosporine, or gemfibrozil.

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