Drug Detail:Fluvastatin (Fluvastatin [ floo-va-sta-tin ])
Drug Class: Statins
Usual Adult Dose for Hyperlipidemia
Initial Dose:
- For patients requiring a low-density lipoprotein cholesterol (LDL-C) reduction of 25% or greater: 40 mg orally twice a day OR 80 mg (extended-release tablet) orally once a day
- For patients requiring an LDL-C reduction of less than 25%: 20 mg orally once a day
- Immediate-release 20 to 80 mg orally per day; for doses greater than 40 mg/day, divide dose and administer twice a day
- Extended-release: 80 mg orally once a day
Comments:
- This drug should be one component of multiple risk factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
- This drug 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).
Use: 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.
Usual Adult Dose for Hyperlipoproteinemia Type IIa (Elevated LDL)
Initial Dose:
- For patients requiring a low-density lipoprotein cholesterol (LDL-C) reduction of 25% or greater: 40 mg orally twice a day OR 80 mg (extended-release tablet) orally once a day
- For patients requiring an LDL-C reduction of less than 25%: 20 mg orally once a day
- Immediate-release 20 to 80 mg orally per day; for doses greater than 40 mg/day, divide dose and administer twice a day
- Extended-release: 80 mg orally once a day
Comments:
- This drug should be one component of multiple risk factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
- This drug 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).
Use: 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.
Usual Adult Dose for Hyperlipoproteinemia Type IIb (Elevated LDL + VLDL)
Initial Dose:
- For patients requiring a low-density lipoprotein cholesterol (LDL-C) reduction of 25% or greater: 40 mg orally twice a day OR 80 mg (extended-release tablet) orally once a day
- For patients requiring an LDL-C reduction of less than 25%: 20 mg orally once a day
- Immediate-release 20 to 80 mg orally per day; for doses greater than 40 mg/day, divide dose and administer twice a day
- Extended-release: 80 mg orally once a day
Comments:
- This drug should be one component of multiple risk factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
- This drug 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).
Use: 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.
Usual Adult Dose for Dyslipidemia
Initial Dose:
- For patients requiring a low-density lipoprotein cholesterol (LDL-C) reduction of 25% or greater: 40 mg orally twice a day OR 80 mg (extended-release tablet) orally once a day
- For patients requiring an LDL-C reduction of less than 25%: 20 mg orally once a day
- Immediate-release 20 to 80 mg orally per day; for doses greater than 40 mg/day, divide dose and administer twice a day
- Extended-release: 80 mg orally once a day
Comments:
- This drug should be one component of multiple risk factor intervention in individuals at increased risk for atherosclerotic vascular disease due to hypercholesterolemia.
- This drug 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).
Use: 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.
Usual Adult Dose for Prevention of Cardiovascular Disease
Immediate-release: 40 mg orally twice a day
Extended-release (XL): 80 mg orally once a day
Comments:
- Among patients with clinically evident coronary heart disease, this drug is indicated to reduce the risk of undergoing coronary revascularization procedures and slow the progression of coronary atherosclerosis.
Use: For the prevention of major adverse cardiac events in patients with coronary heart disease who have undergone successful percutaneous coronary interventions
Usual Pediatric Dose for Heterozygous Familial Hypercholesterolemia
10 years or older:
Initial dose: 20 mg orally once a day
- Dose titration to individualized therapy goal should occur at 6-week intervals;
- Immediate-release 20 to 80 mg orally per day; for doses greater than 40 mg/day, divide dose and administer twice a day
- Extended-release: 80 mg orally once a day
Comments:
- Adolescents treated with this drug should be re-evaluated in adulthood and appropriate changes made to their cholesterol-lowering regimen in accordance with their adult treatment goals.
- This drug 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).
Use: As an adjunct to diet to reduce Total-C, LDL-C, and ApoB levels in adolescent boys and adolescent girls (who are at least 1-year post-menarche) with heterozygous familial hypercholesterolemia and one of the following:
- LDL-C remains at 190 mg/dL or greater
- LDL-C remains at 160 mg/dL or greater with a positive family history of premature cardiovascular disease (CVD)
- LDL-C remains at 160 mg/dL or greater with 2 or more other CVD risk factors
Renal Dose Adjustments
Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction: Doses greater than 40 mg have not been studied and should therefore be used with caution
Liver Dose Adjustments
Active liver disease (including unexplained persistent elevations in hepatic transaminase levels): Contraindicated
Dose Adjustments
Concomitant use with Cyclosporine or Fluconazole:
- Maximum fluvastatin dose: 20 mg orally twice a day
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to the active component or to any of the ingredients
- Active liver disease (including unexplained persistent elevations in hepatic transaminase levels)
- Pregnancy or women who may become pregnant
- Nursing mothers
Safety and efficacy have not been established in patients younger than 10 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
Immediate-release capsules:
- Take orally with or without food
- Capsules should be swallowed whole, do not open prior to administration
- For once a day administration, take in the evening; for doses greater than 40 mg/day; divide dose and take twice a day
- Do not take two 40 mg capsules at one time
- Take orally once a day at any time of day, with or without food
- Swallow whole; do not break, crush, or chew
General:
- This drug has not been studied in conditions where the major abnormality is elevation of chylomicrons, very low density lipoprotein, or intermediate-density lipoprotein (i.e., hyperlipoproteinemia Types I, III, IV, or V).
- This drug should be used in addition to a diet restricted in saturated fat and cholesterol only when response to diet and other nonpharmacologic measures alone has been inadequate.
Monitoring:
- Hepatic: Measure liver enzymes prior to initiation and repeat if signs/symptoms of liver injury occur.
- Metabolic: Measure lipid panels 4 weeks after initiation and upon dose adjustments.
Patient advice:
- Patients should be instructed to read the FDA-approved patient labeling (Patient Information).
- Report immediately any unexplained muscle pain, tenderness, or weakness, especially if accompanied by malaise or fever, or if muscle signs/symptoms persist after discontinuing therapy.
- Promptly report any symptoms that may be indicative of liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice.
- Contraceptive methods should be used while taking this drug.
- Talk to your health care provider if they are pregnant, planning to become pregnant, or breastfeeding; this drug is not recommended for use during pregnancy or in nursing mothers.
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