Therapy with lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).

Hypercholesterolemia (heterozygous familial and nonfamilial) and Mixed Dyslipidemia

Lescol® (fluvastatin sodium) and Lescol® XL (fluvastatin sodium) are indicated to reduce elevated total cholesterol (Total-C), LDL-C, TG and Apo B levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Type IIa and IIb) whose response to dietary restriction of saturated fat and cholesterol and other nonpharmacological measures has not been adequate.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients

Lescol and Lescol XL are indicated as an adjunct to diet to reduce Total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-16 years of age, with heterozygous familial hypercholesterolemia whose response to dietary restriction has not been adequate and the following findings are present:

1. LDL-C remains ≥ 190 mg/dL or
2. 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.

Therapy with lipid-altering agents should be considered only after secondary causes for hyperlipidemia such as poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other medication, or alcoholism, have been excluded. Prior to initiation of fluvastatin sodium, a lipid profile should be performed to measure Total-C, HDL-C and TG. For patients with TG < 400 mg/dL (< 4.5 mmol/L), LDL-C can be estimated using the following equation:

LDL-C = Total-C - HDL-C - 1/5 TG

For TG levels > 400 mg/dL (> 4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In many hypertriglyceridemic patients LDL-C may be low or normal despite elevated Total-C. In such cases, Lescol is not indicated.

Lipid determinations should be performed at intervals of no less than 4 weeks and dosage adjusted according to the patient's response to therapy.s

The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below:

After the LDL-C goal has been achieved, if the TG is still ≥ 200 mg/dL, non-HDL-C (Total-C minus HDL-C) becomes a secondary target of therapy. Non-HDL-C goals are set 30 mg/dL higher than LDL-C goals for each risk category.

At the time of hospitalization for an acute coronary event, consideration can be given to initiating drug therapy at discharge if the LDL-C level is ≥ 130 mg/dL (NCEP-ATP II).

Since the goal of treatment is to lower LDL-C, the NCEP recommends that the LDL-C levels be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy.

Table 4 Classification of Hyperlipoproteinemias

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).

The NCEP classification of cholesterol levels in pediatric patients with a familial history of hypercholesterolemia or premature cardiovascular disease is summarized below:

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.

Secondary Prevention of Coronary Events

In patients with coronary heart disease, Lescol and Lescol XL are indicated to reduce the risk of undergoing coronary revascularization procedures.

Atherosclerosis

Lescol and Lescol XL are also indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total and LDL cholesterol to target levels.

The patient should be placed on a standard cholesterol-lowering diet before receiving Lescol® (fluvastatin sodium) or Lescol® XL (fluvastatin sodium) and should continue on this diet during treatment with Lescol or Lescol XL. (See NCEP Treatment Guidelines for details on dietary therapy.)

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. The recommended dosing range is 20-80 mg/day. Lescol or Lescol XL may be taken without regard to meals, since there are no apparent differences in the lipid-lowering effects of fluvastatin sodium administered with the evening meal or 4 hours after the evening meal. Do not break, crush or chew Lescol XL tablets or open Lescol capsules prior to administration.

Since the maximal reductions in LDL-C of a given dose are seen within 4 weeks, periodic lipid determinations should be performed and dosage adjustment made according to the patient's response to therapy and established treatment guidelines. The therapeutic effect of Lescol or Lescol XL is maintained with prolonged administration.

Heterozygous Familial Hypercholesterolemia in Pediatric Patients

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 INDICATIONS AND USAGE.)¹.

Concomitant Therapy

Lipid-lowering effects on total cholesterol and LDL cholesterol are additive when immediate release Lescol is combined with a bile-acid binding resin or niacin. When administering a bile-acid resin (e.g., cholestyramine) and fluvastatin sodium, Lescol should be administered at bedtime, at least 2 hours following the resin to avoid a significant interaction due to drug binding to resin. (See also ADVERSE REACTIONS: Concomitant Therapy.)

Dosage in Patients with Renal Insufficiency

Since fluvastatin sodium is cleared hepatically with less than 6% of the administered dose excreted into the urine, dose adjustments for mild to moderate renal impairment are not necessary. Fluvastatin has not been studied at doses greater than 40 mg in patients with severe renal impairment; therefore caution should be exercised when treating such patients at higher doses.

Lescol® (fluvastatin sodium) Capsules

20 mg

Brown and light brown imprinted twice with "A "and "20" on one half and "LESCOL" and the Lescol® (fluvastatin sodium) logo twice on the other half of the capsule.

Bottles of 30 capsules...................... NDC 0078-0176-15
Bottles of 100 capsules.................... NDC 0078-0176-05

40 mg

Brown and gold imprinted twice with "A "and "40" on one half and "LESCOL" and the Lescol® (fluvastatin sodium) logo twice on the other half of the capsule.

Bottles of 30 capsules..................... NDC 0078-0234-15
Bottles of 100 capsules................... NDC 0078-0234-05

Lescol® XL (fluvastatin sodium) Extended-Release Tablets

80 mg

Yellow, round, slightly biconvex film-coated tablet with beveled edges debossed with "Lescol XL" on one side and "80" on the other.

Bottles of 30 tablets.......................NDC 0078-0354-15
Bottle of 100 tablets...................... NDC 0078-0354-05

Store and Dispense

Store at 25ºC (77ºF); excursions permitted to 15 -30ºC (59 -86ºF) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from light.

REFERENCES

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.

*Trademark Thomas Healthcare,, Inc.
REV: OCTOBER 2006 FDA rev date: 6/15/2007

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