Indicated as adjunct to diet:

Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia:

• To reduce elevated total cholesterol (Total-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG) and apolipoprotein B (Apo B) levels, and to increase high density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb). 

 • To diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and adolescent girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia and the following findings are present:

• LDL-C remains ≥ 190 mg/dL or
• LDL-C remains ≥ 160 mg/dL and:
• there is a positive family history of premature cardiovascular disease or
• two or more other cardiovascular disease risk factors are present

Secondary Prevention of Cardiovascular Disease:

• In patients with clinically evident CHD, LESCOL/LESCOL XL are indicated to:

• reduce the risk of undergoing coronary revascularization procedures
• slow the progression of coronary atherosclerosis

In patients under 18 years of age, efficacy and safety have not been studied for treatment periods longer than two years.

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).

Statins interfere with cholesterol synthesis and lower circulating cholesterol levels and, as such, might theoretically blunt adrenal or gonadal steroid hormone production.

Rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with LESCOL/LESCOL XL and should be prescribed with caution in patients with predisposing factors for myopathy. These factors include advanced age (>65 years), renal impairment, and inadequately treated hypothyroidism.

There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including fluvastatin. Caution should be exercised when LESCOL/LESCOL XL is administered to patients with a history of liver disease or heavy alcohol ingestion.

Increases in serum transaminases (aspartate aminotransferase [AST]/serum glutamic-oxaloacetic transaminase, or alanine aminotransferase [ALT]/serum glutamic-pyruvic transaminase) have been reported with HMG-CoA reductase inhibitors, including LESCOL/LESCOL XL.

Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including LESCOL/LESCOL XL.

Statins interfere with cholesterol synthesis and lower circulating cholesterol levels and, as such, might theoretically blunt adrenal or gonadal steroid hormone production.

Uncomplicated myalgia has been reported in LESCOL/LESCOL XL-treated patients.

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use.

LESCOL and LESCOL XL are contraindicated:

• in patients with active liver disease or unexplained, persistent elevations in serum transaminases
• in women who are pregnant or may become pregnant. Women who require treatment with LESCOL or LESCOL XL should be advised not to breastfeed their infants

Do not exceed a dose of 20 mg b.i.d. LESCOL/LESCOL XL in patients taking cyclosporine or fluconazole.

Concomitant administration of LESCOL/LESCOL XL with gemfibrozil should be avoided.

Concomitant administration of fluvastatin and glyburide increased glyburide exposures.

Concomitant administration of fluvastatin and phenytoin increased phenytoin exposures.

Bleeding and/or increased prothrombin times have been reported in patients taking coumarin anticoagulants concomitantly with other HMG-CoA reductase inhibitors.

Cases of myopathy, including rhabdomyolysis, have been reported with fluvastatin co-administered with colchicine, and caution should be exercised when prescribing fluvastatin with colchicine.

Because it is known that the risk of myopathy during treatment with HMG-CoA reductase inhibitors is increased with concurrent administration of other fibrates, LESCOL/LESCOL XL should be administered with caution when used concomitantly with other fibrates.

The risk of skeletal muscle effects may be enhanced when LESCOL/LESCOL XL is used in combination with lipid modifying doses (≥1 g/day) of niacin; a reduction in LESCOL/LESCOL XL dosage should be considered in this setting.

Bleeding and/or increased prothrombin times have been reported in patients taking coumarin anticoagulants concomitantly with other HMG-CoA reductase inhibitors. Therefore, patients receiving warfarin-type anticoagulants should have their prothrombin times closely monitored when fluvastatin sodium is initiated or the dosage of fluvastatin sodium is changed.

LESCOL and LESCOL XL are contraindicated in women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. LESCOL and LESCOL XL may cause fetal harm when administered to pregnant women.

Fluvastatin is secreted into the breastmilk of animals and because HMG-CoA reductase inhibitors have the potential to cause serious adverse reactions in nursing infants, women who require treatment with LESCOL or LESCOL XL should be advised not to breastfeed their infants.

GoToSource

• Adult dosage greater than 80 mg per day. GoToSource

• Use in patients under the age of 10. GoToSource 

• Use in children who lack heterozygous familial hypercholesterolemia. GoToSource

• Autoimmune disease. GoToSource

• Polycystic ovarian syndrome. GoToSource

• Chronic obstructive pulmonary disease. GoToSource

• Sepsis. GoToSource

• Prevention of contrast-induced nephropathy. GoToSource

• Age-related macular degeneration. GoToSource

• Subarachnoid hemorrhage. GoToSource

• Use as anti-osteoporotic agent. GoToSource

• Asthma. GoToSource

• Decrease risk of recurrent VTE. GoToSource

• Prevention and treatment of cancer. GoToSource

Rhabdomyolysis (breakdown of muscle tissue). GoToSource

Amyotrophic lateral sclerosis (lou gehrig’s disease). GoToSource

Dermatomyositis (inflammation of the skin and underlying muscle tissue). GoToSource

Myopathy (muscular disease). GoToSource

Liver damage. GoToSource

Cognitive impairment including memory loss and confusion, increased blood sugar levels and development of type 2 diabetes. GoToSource 

Increased risk of cataracts. GoToSource

Lawsuits filed for rhabdomyolysis, myopathy, kidney damage and diabetes.