Lescol XL

LESCOL XL- fluvastatin sodium tablet, extended release
Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other non-pharmacologic measures alone has been inadequate.

1.1 Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

LESCOL XL is indicated

  • as an adjunct to diet 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).
  • as an adjunct 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

The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature CVD is summarized below.

Category Total-C (mg/ dL ) LDL-C (mg/ dL )
Acceptable < 170 < 110
Borderline 170-199 110-129
High ≥ 200 ≥ 130

Children treated with fluvastatin in adolescence should be reevaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen to achieve adult treatment goals.

1.2 Secondary Prevention of Cardiovascular Disease

In patients with clinically evident Coronary Heart Disease (CHD), LESCOL XL is indicated to:

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

1.3 Limitations of Use

LESCOL XL has not been studied in conditions where the major abnormality is elevation of chylomicrons, VLDL, or IDL (i.e., hyperlipoproteinemia Types I, III, IV, or V).

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

Dose range: 20 mg to 80 mg/day.

LESCOL XL can be administered orally as a single dose, with or without food.

Do not break, crush or chew LESCOL XL tablets prior to administration.

Since the maximal effect of a given dose is seen within 4 weeks, periodic lipid determinations should be performed at this time and dosage adjusted according to the patient’s response to therapy and established treatment guidelines.

For patients requiring LDL-C reduction to a goal of ≥ 25%, the recommended starting dose is 80 mg as one LESCOL XL tablet administered as a single dose at any time of the day. For patients requiring LDL-C reduction to a goal of < 25%, a starting dose of 20 mg may be used.

2.2 Adult Patients With Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

The recommended starting dose for LESCOL XL is one 80 mg tablet administered as a single dose at any time of the day.

2.3 Pediatric Patients (10 to 16 years of age) With Heterozygous Familial Hypercholesterolemia

The recommended starting dose is one 20 mg fluvastatin capsule. Dose adjustments, up to a maximum daily dose administered one LESCOL XL 80 mg tablet once daily should be made at 6-week intervals. Doses should be individualized according to the goal of therapy [see NCEP Pediatric Panel Guidelines and Clinical Studies (14)] 1.

1 National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.

2.4 Use With Cyclosporine

Do not exceed a dose of 20 mg twice-daily fluvastatin capsules in patients taking cyclosporine [see Drug Interactions (7.1)].

2.5 Use With Fluconazole

Do not exceed a dose of 20 mg twice-daily fluvastatin capsules in patients taking fluconazole [see Drug Interactions (7.2)].

3 DOSAGE FORMS AND STRENGTHS

LESCOL XL 80 mg tablets are yellow, round, slightly biconvex film-coated tablets with beveled edges debossed with “LESCOL XL” on one side and “80” on the other.

4 CONTRAINDICATIONS

4.1 Hypersensitivity to Any Component of This Medication

LESCOL XL is contraindicated in patients with hypersensitivity to any component of this medication.

4.2 Active Liver Disease

LESCOL XL is contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [see Warnings and Precautions (5.3) ].

4.3 Pregnancy

LESCOL XL is 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 XL may cause fetal harm when administered to pregnant women. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia.

LESCOL XL should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards. If the patient becomes pregnant while taking this drug, LESCOL XL should be discontinued and the patient should be apprised of the potential hazard to the fetus [see Use in Specific Populations (8.1) ].

4.4 Nursing Mothers

Fluvastatin is secreted into the breast milk 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 XL should be advised not to breastfeed their infants [see Use in Specific Populations (8.3) ].

5 WARNINGS AND PRECAUTIONS

5.1 Skeletal Muscle

Rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with LESCOL XL and other drugs in this class.

LESCOL XL 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.

The risk of myopathy and/or rhabdomyolysis with statins is increased with concurrent therapy with cyclosporine, erythromycin, fibrates or niacin. Myopathy was not observed in a clinical trial in 74 patients involving patients who were treated with LESCOL XL together with niacin. Isolated cases of myopathy have been reported during postmarketing experience with concomitant administration of LESCOL XL and colchicine. No information is available on the pharmacokinetic interaction between LESCOL XL and colchicine.

Uncomplicated myalgia has also been reported in fluvastatin-treated patients [see Adverse Reactions (6) ]. In clinical trials, uncomplicated myalgia has been observed infrequently in patients treated with fluvastatin at rates indistinguishable from placebo. Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in CPK values to greater than 10 times the upper limit of normal, was < 0.1% in fluvastatin clinical trials. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of CPK.

All patients should be advised to promptly report to their physician unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing LESCOL XL.

LESCOL XL therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. LESCOL XL therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy.

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