Lescol XL

LESCOL XL- fluvastatin sodium tablet, extended release
Carilion Materials Management

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 and LESCOL XL are 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 re-evaluated 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 CHD, LESCOL and LESCOL XL are indicated to:

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

1.3 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).

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Information

Dose range: 20 mg to 80 mg/ day.

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

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

Do not take two LESCOL 40 mg capsules at one time.

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 40 mg as one capsule in the evening, 80 mg as one LESCOL XL tablet administered as a single dose at any time of the day or 80 mg in divided doses of the 40 mg capsule given twice daily. 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

Adult patients can be started on either LESCOL or LESCOL XL. The recommended starting dose for LESCOL is one 40 mg capsule in the evening, or one LESCOL 40 mg capsule twice daily. Do not take two LESCOL 40 mg capsules at one time.

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 (10-16 years of age) with Heterozygous Familial Hypercholesterolemia

The recommended starting dose is one 20 mg LESCOL capsule. Dose adjustments, up to a maximum daily dose administered either as LESCOL capsules 40 mg twice daily or 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

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

2.4 Use with Cyclosporine

Do not exceed a dose of 20 mg b.i.d. LESCOL in patients taking cyclosporine . [see Drug Interactions 7.1]

2.5 Use with Fluconazole

Do not exceed a dose of 20 mg b.i.d. LESCOL in patients taking fluconazole . [see Drug Interactions 7.2]

3 DOSAGE FORMS AND STRENGTHS

• LESCOL 20 mg capsules are brown and light brown imprinted twice with “ ” and “20” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule. ^®

• LESCOL 40 mg capsules are brown and gold imprinted twice with “ ” and “40” on one half and “LESCOL” and the LESCOL (fluvastatin sodium) logo twice on the other half of the capsule. ^®

• LESCOL XL 80 mg tablets are yellow, round, slightly biconvex film-coated tablet 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 and LESCOL XL are contraindicated in patients with hypersensitivity to any component of this medication.

4.2 Active Liver Disease

LESCOL and LESCOL XL are contraindicated in patients with active liver disease or unexplained, persistent elevations in serum transaminases [ ]. see Warnings and Precautions (5.2)

4.3 Pregnancy

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. 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 and 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 and 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 or LESCOL XL should be advised not to breastfeed their infants [ ]. see Use In Specific Populations (8.3)