Lescol
NDC Package 54868-3329-0

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

30 EA

-

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 DyslipidemiaLescol® (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 PatientsLescol 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:LDL-C remains > 190 mg/dL orLDL-C remains > 160 mg/dL and: there is a positive family history of premature cardiovascular disease ortwo 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.      The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below: Table 3 NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk CategoriesRisk CategoryLDL Goal (mg/dL)LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL)LDL Level at Which to Consider Drug Therapy (mg/dL)CHD† or CHD risk equivalents (10-year risk >20%)<100>100>130 (100-129: drug optional)††2+ Risk factors (10-year risk <20%)<130>13010-year risk 10%-20%: >130 10-year risk <10%: >1600-1 Risk factor†††<160>160>190 (160-189: LDL-lowering drug optional)† CHD, coronary heart disease†† Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of <100mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgement also may call for deferring drug therapy in this subcategory.††† Almost all people with 0-1 risk factor have 10-year risk <10%; thus, 10-year risk assessment in people with 0-1 risk factor is not necessary.      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      Lipid ElevationsTypeLipoproteins ElevatedMajorMinorI (rare)ChylomicronsTG↑→CIIaLDLC–IIbLDL, VLDLCTGIII (rare)IDLC/TG–IVVLDLTG↑→CV (rare)Chylomicrons, VLDLTG↑→CC = cholesterol, TG = triglycerides, LDL = low density lipoprotein, VLDL = very low density lipoprotein, IDL = intermediate density lipoprotein      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:CategoryTotal-C (mg/dL)LDL-C (mg/dL)AcceptableBorderlineHigh<170170-199>200<110110-129>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.Secondary Prevention of Coronary EventsIn patients with coronary heart disease, Lescol and Lescol XL are indicated to reduce the risk of undergoing coronary revascularization procedures.AtherosclerosisLescol 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.

Physicians Total Care, Inc.

NDA020261

NDA - A product marketed under an approved New Drug Application.

06-10-1994

12-31-2017

I

No