LESCOL/LESCOL XL is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:

• Reduce elevated TC, LDL-C, Apo B, and TG, and to increase HDL-C in adult patients with primary hypercholesterolemia and mixed dyslipidemia
• Reduce elevated TC, LDL-C, and Apo B levels in boys and post-menarchal girls, 10 to 16 years of age, with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy
• Reduce the risk of undergoing revascularization procedures in patients with clinically evident CHD
• Slow the progression of atherosclerosis in patients with CHD

Limitations of Use:

• Neither LESCOL nor LESCOL XL have been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V)

Most frequent adverse reactions (rate ≥2% and > placebo) are: headache, dyspepsia, myalgia, abdominal pain and nausea.

• Cyclosporine: Combination increases fluvastatin exposure. Limit LESCOL dose to 20 mg
• Fluconazole: Combination increases fluvastatin exposure. Limit LESCOL dose to 20 mg
• Concomitant lipid-lowering therapies: Use with fibrates or lipidmodifying doses (≥1 g/day) of niacin increases the risk of adverse skeletal muscle effects. Caution should be used when prescribing with LESCOL/LESCOL XL
• Glyburide: Monitor blood glucose levels when fluvastatin dose is changed
• Phenytoin: Monitor plasma phenytoin levels when fluvastatin treatment is initiated or when the dosage is changed
• Warfarin and coumarin derivates: Monitor prothrombin times when fluvastatin co-administration is initiated, discontinued, or the dosage changed

• 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
• Patients should be advised to report promptly any symptoms of myopathy. LESCOL/LESCOL XL therapy should be discontinued if myopathy is diagnosed or suspected
• Liver enzyme abnormalities: Persistent elevations in hepatic transaminases can occur. Check liver enzyme tests before initiating therapy and as clinically indicated thereafter