What is fluvastatin used for?

Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA078407). Cross-references to other label sections are left out.

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.

Hypercholesterolemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia

Fluvastatin capsules 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 to 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.

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 Cardiovascular Disease

In patients with clinically evident CHD, fluvastatin capsules are indicated to:

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

Limitations of Use

Fluvastatin capsules have 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).

Source: DailyMed label, set id aad8b373-0aec-4efb-8e61-3d8114b31127, version 12, effective April 21, 2025. NDC 0093-7442, one of 9 listings for this product.

Indications and Usage, quoted from the label by Lannett Company, Inc. (ANDA209397). Cross-references to other label sections are left out.

Fluvastatin sodium extended-release tablets are indicated:

• To reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis in adults with clinically evident coronary heart disease.
• As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
• As an adjunct to diet to reduce LDL-C in adults and pediatric patients 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH) who require 80 mg of fluvastatin daily.

Source: DailyMed label, set id 3565bfd3-ef9f-456d-b4be-a294a7a0f01c, version 13, effective March 18, 2026. NDC 0527-2580, one of 2 listings for this product.