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Generic Name: Fluvastatin Sodium
Class: HMG-CoA Reductase Inhibitors
VA Class: CV350
Chemical Name: [R*,S*-(E)]-(±)-7-[3-(4-Fluo rophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic acid monosodium salt
Molecular Formula: C24H26FNO4•Na
CAS Number: 93957-55-2

Introduction

Antilipemic agent; hydroxymethylglutaryl-CoA (HMG-CoA) reductase inhibitor (i.e., statin).1 4 5

Uses for Lescol

Prevention of Cardiovascular Events

Adjunct to nondrug therapies (e.g., dietary management) in patients with CHD to reduce the risk of undergoing coronary revascularization procedures.72

Adjunct to nondrug therapies (e.g., dietary management) in patients with CHD to slow the progression of coronary atherosclerosis.72

Dyslipidemias

Adjunct to nondrug therapies (e.g., dietary management) to decrease elevated serum total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIa or IIb).1 72

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Adjunct to nondrug therapies (e.g., dietary management) to decrease elevated serum total cholesterol, LDL-cholesterol, and apo B concentrations in the management of heterozygous familial hypercholesterolemia in boys and girls (≥1 year postmenarchal) 10–16 years of age who, despite an adequate trial of dietary management, have a serum LDL-cholesterol concentration of ≥190 mg/dL or a serum LDL-cholesterol concentration of ≥160 mg/dL and either a family history of premature cardiovascular disease or ≥2 other cardiovascular risk factors.1 72

Reduction of total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus (diabetic dyslipidemia),54 renal insufficiency,63 cardiac or renal transplantation,20 21 22 21 27 55 57 64 or nephrotic syndrome (nephrotic hyperlipidemia).24 65

Lescol Dosage and Administration

General

  • Patients should be placed on a standard lipid-lowering diet before initiation of fluvastatin therapy and should remain on this diet during treatment with the drug.1 60

Monitoring during Antilipemic Therapy

  • Monitor lipoprotein concentrations periodically to ensure that target LDL-cholesterol goals are achieved and maintained at <100 mg/dL (optional goal: <70 mg/dL) for patients with CHD or CHD risk equivalents; <130 mg/dL (optional goal: <100 mg/dL) for patients with ≥2 risk factors and 10-year risk of 10–20%; <130 mg/dL for patients with ≥2 risk factors and 10-year risk <10%; or <160 mg/dL for patients with 0–1 risk factor.

Administration

Oral Administration

Administer orally without regard to meals.1

Administer conventional capsules once (in the evening) or twice daily;1 do not administer two 40-mg capsules at one time.72 Do not open capsules prior to administration.1

Administer extended-release tablets as a single dose at any time of day.1 Do not break, crush, or chew tablets.1

Dosage

Available as fluvastatin sodium; dosage expressed in terms of fluvastatin.1

Pediatric Patients

Dyslipidemias
Oral

Children 10–16 years of age: Initially, 20 mg once daily.1

Adjust dosage at 6-week intervals until the desired effect on lipoprotein concentrations is observed or a daily dosage of 80 mg (administered as 40 mg twice daily as conventional capsules or 80 mg once daily as extended-release tablets) is reached.1 72

Adults

Prevention of Cardiovascular Events or Management of Dyslipidemias
Oral

Patients who require reductions in LDL-cholesterol concentrations of <25%: Initially, 20 mg once daily in the evening.1

Patients who require reductions of >25% in LDL-cholesterol concentrations or patients with primary hypercholesterolemia or mixed dyslipidemia: Initially, 40 mg (as conventional capsules) once daily in the evening, 80 mg (as extended-release tablets) once daily at any time of day, or 40 mg (as conventional capsules) twice daily.1 72

Adjust dosage at intervals of ≥4 weeks until the desired effect on lipoprotein concentrations is observed.1

Usual maintenance dosage is 20–80 mg daily.1

Prescribing Limits

Pediatric Patients

Oral

Children 10–16 years of age: Maximum 80 mg daily.1

Special Populations

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease; monitor such patients closely.1

Contraindicated in patients with active liver disease or unexplained, persistent increases in serum aminotransferase concentrations.1

Renal Impairment

Dosage modification is not necessary in patients with mild to moderate renal impairment.1

Dosages >40 mg daily have not been studied in patients with severe renal impairment; use caution when administering higher dosages to such patients.1

Cautions for Lescol

Contraindications

  • Active liver disease or unexplained, persistent elevations of serum aminotransferases.1

  • Pregnancy or lactation.1 Administer to women of childbearing age only when they are highly unlikely to conceive and have been informed of the potential hazards.1

  • Known hypersensitivity to fluvastatin or any ingredient in the formulation.1

Warnings/Precautions

Fetal/Neonatal Morbidity and Mortality

Suppression of cholesterol biosynthesis could cause fetal harm.1 Congenital anomalies following intrauterine exposure to statins reported rarely.1

Administer to women of childbearing age only when they are highly unlikely to conceive and have been informed of the potential hazards.1 If the patient becomes pregnant while taking the drug, discontinue therapy and apprise the patient of the potential hazard to the fetus.1

Musculoskeletal Effects

Myopathy (manifested as muscle pain, tenderness, or weakness and serum CK [CPK] concentration increases >10 times the ULN) has been reported.1

Rhabdomyolysis (characterized by muscle pain or weakness with marked increases [>10 times the ULN] in serum CK concentrations and increases in Scr [usually accompanied by brown urine and urinary myoglobinuria]) with acute renal failure secondary to myoglobinuria has been reported.1 72

Risk of myopathy increased in patients receiving higher dosages of statins; patients with multisystem disease (e.g., renal or hepatic impairment), concurrent serious infections, or inadequately treated hypothyroidism; geriatric patients (>65 years of age); patients with small body frame and frailty; and patients undergoing surgery (i.e., during perioperative periods).72

Certain drug interactions also may increase risk of myopathy and/or rhabdomyolysis.1 72 (See Specific Drugs under Interactions.)

Use with caution in patients with predisposing factors for myopathy (e.g., advanced age [>65 years of age], renal impairment, inadequately treated hypothyroidism).72

Measure baseline serum CK concentrations prior to initiation of therapy, particularly in patients at high risk of developing musculoskeletal toxicity (e.g., geriatric patients, black men, patients receiving concomitant therapy with myotoxic drugs).

Obtain serum CK concentrations and compare with baseline concentrations in patients presenting with musculoskeletal symptoms suggestive of myopathy; because hypothyroidism may be a predisposing factor, TSH concentrations also should be obtained in such patients.

Consider myopathy in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked CK elevation.72 Discontinue therapy if serum CK concentrations become markedly elevated or if myopathy is diagnosed or suspected.1

Monitor patients weekly if myalgia (muscle pain, tenderness) is present with either no CK elevation or a moderate elevation (3–10 times the ULN) until manifestations improve; discontinue if manifestations worsen.

Dosage reduction or temporary discontinuance may be prudent in patients with muscle discomfort and/or weakness in the presence of progressive elevation of CK concentrations on serial measurements.

Temporarily withhold therapy in any patient experiencing an acute or serious condition predisposing to the development of acute renal failure secondary to rhabdomyolysis (e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures).1 Initiate IV hydration therapy (in a hospital setting) in patients experiencing rhabdomyolysis as needed.

Hepatic Effects

Increases in serum aminotransferase (AST, ALT) concentrations reported.1 Generally transient and resolve or improve with continued therapy or after temporary interruption in therapy.72

Persistent aminotransferase elevations (>3 times the ULN on 2 consecutive weekly measurements) are more common at higher dosages (40 or 80 mg daily).72 Most cases occurred within 12 weeks of therapy.72

Fatal and nonfatal hepatic failure reported rarely.72 Possibly drug-related hepatitis, which resolved following discontinuance of therapy, reported very rarely.72

Perform liver function tests before initiation of therapy and as clinically indicated (e.g., presence of manifestations suggestive of liver damage201 ).72 Although manufacturer previously recommended more frequent monitoring, FDA concluded that serious statin-related liver injury is rare and unpredictable, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.200

If serious liver injury with clinical manifestations and/or hyperbilirubinemia or jaundice occurs, promptly interrupt fluvastatin therapy.72 If an alternate etiology is not found, do not restart fluvastatin.72

Also see Hepatic Impairment under Cautions.

Hyperglycemic Effects

Increases in HbA1c and fasting serum glucose concentrations reported.72 200 Possible increased risk of developing diabetes.200 May need to monitor glucose concentrations following initiation of statin therapy.201

FDA states that cardiovascular benefits of statins outweigh these small increased risks.200

Endogenous Steroid Production

Statins interfere with cholesterol synthesis and theoretically may blunt adrenal and/or gonadal steroid production.72

Fluvastatin had no effect on nonstimulated cortisol concentrations, adrenal response to corticotropin (adrenocorticotropic hormone, ACTH) stimulation, or thyroid metabolism.72 Small declines in total serum testosterone concentrations reported, but no commensurate elevation in LH concentrations, and no effect on FSH concentrations in men.72 Data insufficient to determine effect on female sex hormones.72

If clinical evidence of endocrine dysfunction is present, evaluate patients appropriately.72

Caution advised if a statin or another antilipemic agent is used concomitantly with drugs that may decrease concentrations or activity of endogenous steroid hormones (e.g. ketoconazole, spironolactone, cimetidine).72

Cognitive Impairment

Cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) reported rarely.72

Generally nonserious and reversible, with variable times to symptom onset (1 day to years) and resolution (median of 3 weeks following discontinuance of therapy).72 200 Not associated with fixed or progressive dementia (e.g., Alzheimer’s disease) or clinically important cognitive decline.200 Not associated with any specific statin, patient's age, statin dosage, or concomitant drug therapy.200

FDA states that cardiovascular benefits of statins outweigh the small increased risk of cognitive impairment.200

If manifestations consistent with cognitive impairment occur, National Lipid Association (NLA) statin safety assessment task force recommends evaluating and managing patients appropriately.202

Role as Adjunct Therapy

Prior to institution of antilipemic therapy, vigorously attempt to control serum cholesterol by appropriate dietary regimens, weight reduction, exercise, and treatment of any underlying disorder that might be the cause of lipid abnormality.1

Specific Populations

Pregnancy

Category X.1 (See Contraindications and also see Fetal/Neonatal Morbidity and Mortality, under Cautions.)

Lactation

Distributed into milk in animals.72 Use is contraindicated in nursing women; women who require fluvastatin therapy should not breast-feed their infants.72

Pediatric Use

Safety and efficacy not established in children <9 years of age or in premenarchal girls.1 72 (See Advice to Patients.)

Geriatric Use

Fluvastatin exposures not substantially different between patients ≥65 years of age and younger adults.72

Use with caution, since age ≥65 years is a predisposing factor for myopathy.72

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease.1

Contraindicated in patients with active liver disease or unexplained, persistent increases in liver function test results.1

Common Adverse Effects

Headache, dyspepsia, myalgia, abdominal pain, nausea.72

Interactions for Lescol

Metabolized principally by CYP2C9; CYP2C8 and CYP3A4 also contribute to fluvastatin metabolism.1

Specific Drugs

Drug

Interaction

Comments

Bile acid sequestrants (e.g., cholestyramine)

Additive cholesterol-lowering effects45

Decreased fluvastatin peak plasma concentration and AUC when administered 4 hours after cholestyramine and a meal72

Administer statins 1 hour before or 4 hours after the resin69

Colchicine

Myopathy, including rhabdomyolysis, reported72

Use concomitantly with caution72

Cyclosporine

Increased fluvastatin concentrations;1 increased risk of myopathy and/or rhabdomyolysis1

If used concomitantly, limit fluvastatin dosage to 20 mg twice daily72

Diclofenac

Increased fluvastatin and diclofenac concentrations72

Digoxin

Slight increase in digoxin peak plasma concentration72

Erythromycin

Increased risk of myopathy and/or rhabdomyolysis1

Fibric acid derivatives (e.g., fenofibrate, gemfibrozil)

Increased risk of myopathy and/or rhabdomyolysis1

Gemfibrozil: Avoid concomitant use72

Other fibric acid derivatives: Use concomitantly with caution72

Fluconazole

Increased peak plasma concentration and AUC of fluvastatin1

If used concomitantly, limit fluvastatin dosage to 20 mg twice daily72

Glyburide

Increased fluvastatin and glyburide concentrations;1 no change in glucose, insulin, or C-peptide concentrations1

Monitor appropriately72

Histamine H2-receptor antagonists (e.g., cimetidine, ranitidine)

Increased plasma concentrations and decreased clearance of fluvastatin1

Niacin (antilipemic dosages [≥1 g daily])

Increased risk of myopathy and/or rhabdomyolysis1

If used concomitantly, consider reducing fluvastatin dosage72

Phenytoin

Increased fluvastatin and phenytoin concentrations1

Patients receiving phenytoin should be monitored appropriately when fluvastatin is initiated or dosage is adjusted1

Proton-pump inhibitors (e.g., omeprazole)

Increased plasma concentrations and decreased clearance of fluvastatin1

Rifampin

Decreased peak plasma concentration and AUC of fluvastatin72

Warfarin

Bleeding and/or increased PT observed with other statins1

Closely monitor PT until stabilized if fluvastatin is initiated or dosage is adjusted in patients receiving warfarin1

Lescol Pharmacokinetics

Pharmacokinetic data in pediatric patients not available.1

Absorption

Bioavailability

Rapidly and completely absorbed.1

Absolute bioavailability of conventional capsules is 24%.1

The mean relative bioavailability of extended-release tablets is approximately 29% compared with conventional capsules administered under fasting conditions.1

Mean peak plasma concentrations occur within 1 or 3 hours following oral administration of conventional capsules or extended-release tablets, respectively.1

Onset

A therapeutic response usually is apparent within 2 weeks after initiating therapy, with a maximal response occurring within 4 weeks.1

Food

Peak plasma concentration decreased and time to peak plasma concentrations increased following administration of fluvastatin conventional capsules with the evening meal; however, no substantial differences in lipid-lowering effects following administration with food.1 72

Bioavailability increased and absorption delayed following administration of extended-release tablets with a high-fat meal; however, peak plasma concentrations achieved with the extended-release tablets following a high-fat meal are much less than those achieved with a single or twice-daily dose of 40 mg.1

Distribution

Extent

Distributed mainly to the liver.1

Distributed into milk (milk to plasma ratio 2:1).1

Plasma Protein Binding

About 98%.1

Elimination

Metabolism

Metabolized in the liver, principally by CYP2C9 and to a lesser extent by CYP3A4 and CYP2C8.1

Elimination Route

Excreted in feces (90%) and urine (5%) mainly as metabolites; <2% excreted as unchanged drug.1

Half-life

<3 hours (conventional capsules) and 9 hours (extended-release tablets).1

Special Populations

Patients with hepatic impairment may have increased exposure to fluvastatin due to decreased presystemic metabolism.1

Stability

Storage

Oral

Capsules and Extended-release Tablets

Tight containers at 25°C (may be exposed to 15–30°C).1 Protect from light.1

Actions

  • Inhibits HMG-CoA reductase, causing subsequent reduction in hepatic cholesterol synthesis.1 Reduces serum concentrations of total cholesterol, LDL-cholesterol, apo B, and triglycerides.1

  • Statins may slow progression of and/or induce regression of atherosclerosis in coronary and/or carotid arteries, modulate BP in hypercholesterolemic patients with hypertension, and possess anti-inflammatory activity.

Advice to Patients

  • Importance of adhering to nondrug therapies and measures (i.e., therapeutic lifestyle changes), including dietary management, weight control, physical activity, and management of potentially contributory disease [e.g., diabetes mellitus]).

  • Importance of informing patients about risks, especially rhabdomyolysis, associated with statins alone or combined with other drugs.1 Importance of patients promptly reporting muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.1

  • Risk of adverse hepatic effects.72 Importance of promptly reporting any symptoms suggestive of liver injury (e.g., fatigue, anorexia, right upper abdominal discomfort, dark urine, jaundice).72

  • Risk of nonserious, reversible cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion).72 200

  • Risk of increased glucose concentrations and development of type 2 diabetes.72 200 May need to monitor glucose concentrations following initiation of statin therapy.201

  • Importance of advising women and adolescent girls to avoid pregnancy (i.e., using effective contraceptive methods) during therapy; if the patient becomes pregnant, importance of immediately discontinuing fluvastatin and contacting a clinician.1 72

  • Importance of avoiding breast-feeding during therapy.72 If the patient has a lipid disorder and is breast-feeding, importance of contacting a clinician to discuss other antilipemic treatment options.72

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Fluvastatin Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

20 mg (of fluvastatin)*

Fluvastatin Sodium Capsules

Lescol

Novartis

40 mg (of fluvastatin)*

Fluvastatin Sodium Capsules

Lescol

Novartis

Tablets, extended-release

80 mg (of fluvastatin)

Lescol XL

Novartis

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Lescol 20MG Capsules (NOVARTIS): 30/$117.59 or 90/$317.07

Lescol 40MG Capsules (NOVARTIS): 30/$109.19 or 90/$293.96

Lescol XL 80MG 24-hr Tablets (NOVARTIS): 30/$145.99 or 90/$425.95

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions February 15, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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47. Fanghanel G, Espinosa J, Olivares D et al. Open-label study to assess the efficacy, safety, and tolerability of fluvastatin versus bezafibrate for hypercholesterolemia. Am J Cardiol. 1995; 76:57-61A.

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49. Leitersdorf E, Muratti EN, Eliav O et al. Efficacy and safety of a combination fluvastatin-bezafibrate treatment for familial hypercholesterolemia: comparative analysis with a fluvastatin-cholestyramine combination. Am J Med. 1994; 96:401-7. [IDIS 330972] [PubMed 8192170]

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51. Sigurdsson G, Haraldsdottir SO, Melberg TH et al. fluvastatin compared to fluvastatin in the reduction of serum lipids and apolipoproteins in patients with ischaemic heart disease and moderate hypercholesterolaemia. Acta Cardiol. 1998; 1:7-14.

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53. Serruys PW, Foley DP, Jackson G et al. A randomized placebo-controlled trial of fluvastatin for prevention of restenosis after successful coronary balloon angioplasty. Eur Heart J. 1999; 20:58-69. [PubMed 10075142]

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