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fluvastatin (Rx)Brand and Other Names:Lescol, Lescol XL

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsules

  • 20mg
  • 40mg

tablets, extended release

  • 80mg
more...

Hypercholesterolemia & Mixed Dyslipidemia

Start 20-40 mg PO qHS

Dose range 20-80 mg PO qDay

If 80 mg/day needed, divide into 40 mg PO q12hr

Sustained-release (Lescol XL): 80 mg PO qDay

Patients Requiring <25% Decrease in LDL-C

20 mg PO qDay; may adjust dose based on response and tolerability not to exceed 40 mg PO q12hr (immediate release capsule) or 80 mg PO q24hr extended release tablet

Renal Impairment

CrCl <30 mL/min: Adjust dose amount; not to exceed 40 mg/day

Hepatic Impairment

Contraindicated in active liver disease or unexplained transaminase elevations

Overdose Management

Adverse drug reactions from overdose may include peripheral neuropathy, diarrhea, increased K+, myopathy, rhabdomyolysis, acute renal failure, elevated LFT's, eye lens opacities

Treatment is supportive

Dosage Forms & Strengths

capsules

  • 20mg
  • 40mg

tablets, extended release

  • 80mg
more...

Heterozygous Familial Hypercholesterolemia

Indicated for adolescents unresponsive to dietary restriction and LDL-C remains >190 mg/dL, OR LDL-C >160 mg/dL AND positive family history exists or 2 or more cardivascular risk factors; girls must be at least 1 year postmenarche

<10 years: Safety and efficacy not established

10-16 years: 20 mg PO qHS initially; may increase dose at 6 week intervals up to 40 mg PO q12hr immediate release or 80 mg (Lescol XL) PO qDay

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Interactions

Interaction Checker

fluvastatin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Headache (9%)

            Dyspepsia (8%)

            Abdominal pain (5%)

            Diarrhea (5%)

            Myalgia (5%)

            Fatigue (3%)

            Insomnia (3%)

            Nausea (3%)

            Sinusitis (3%)

            Bronchitis (2%)

            UTI (2%)

            Transaminases increased (1.1%)

            <1%

            Rash

            Back pain

            Arthralgia

            Myopathy

            Rhabdomyolysis

            Rupture of tendon

            CPK increased

            Pharyngitis

            Rhinitis

            Cough

            Constipation

            Pancreatitis

            Dizziness

            Postmarketing Reports

            Musculoskeletal: Muscle cramps, myalgia, myopathy, rhabdomyolysis, arthralgias, muscle spasms, muscle weakness, myositis

            Neurological: Dysfunction of certain cranial nerves (including alteration of taste, impairment of extra-ocular movement, facial paresis), tremor, dizziness, vertigo, paresthesia, hypoesthesia, dysesthesia, peripheral neuropathy, peripheral nerve palsy; also rare reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use

            Psychiatric: Anxiety, insomnia, depression, psychic disturbances

            Hypersensitivity reactions: Hypersensitivity syndrome including anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, increased ESR, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity reaction, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, and erythema multiforme including Stevens-Johnson syndrome

            Gastrointestinal: Pancreatitis, hepatitis, including chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, hepatoma, anorexia, vomiting, fatal and nonfatal hepatic failure

            Skin: Rash, dermatitis, including bullous dermatitis, eczema, alopecia, pruritus, a variety of skin changes (eg, nodules, discoloration, dryness of skin/mucous membranes, changes to hair/nails)

            Reproductive: Gynecomastia, loss of libido, erectile dysfunction

            Eye: Progression of cataracts (lens opacities), ophthalmoplegia

            Laboratory abnormalities: Elevated transaminases, alkaline phosphatase, gamma-glutamyl transpeptidase and bilirubin; thyroid function abnormalities

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            Warnings

            Contraindications

            Hypersensitivity to fluvastatin

            Active liver disease, or unexplained elevated transminases

            Pregnancy, lactation

            Cautions

            Non-serious and reversible cognitive side effects may occur

            Increased blood sugar and glycosylated hemoglobin (HbA1c) levels reported with statin intake

            Heavy alcohol use, history of liver disease, renal failure

            Myopathy, risk of myopathy - incr by co-administration w/ fibrates, niacin, cyclosporine, macrolides, azole antifungals.

            Withhold or discontinue treatment if myopathy develops, renal failure, or transaminase levels >3 times the upper limit of normal

            Rare reports of immune-mediated necrotizing myopathy (IMNM), characterized by increased serum creatine kinase that persist despite discontinuing statin

            Lipid-lowering effects additive with bile-acid binding resin or niacin

            Take 2 hr after bile acid sequestrant

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            Pregnancy & Lactation

            Pregnancy Category: X

            Lactation: enters breast milk; contraindicated

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            HMG-CoA reductase inhibitor, inhibits the rate-limiting step in cholesterol biosynthesis by competitively inhibiting HMG-CoA reductase

            Absorption

            Bioavailability: 24% (capsule); 29% (extended release tablet)

            Onset: 3-4 wk (Lescol)

            Peak Plasma Time: 0.5-1 hr (capsule); 3hr (extended release tablet)

            Distribution

            Protein Bound: 98% (Lescol)

            Vd: 0.35 L/kg (Lescol)

            Metabolism

            Metabolite: No active metabolite

            Metabolism: hepatic P450 enzyme CYP2C9 (75%); CYP2C8 (5%); CYP3A4 (20%)

            Elimination

            Half-Life: <3 hr (capsule); 9hr (extended release tablet)

            Total Body Clearance: 0.97 L/hr/kg (Lescol)

            Excretion: feces (95%), urine (5%) (Lescol)

            Pharmacogenomics

            SLCO1B1 (OATP1B1) CC genotype significantly increases AUCs of parent drug and metabolites compared with the CT or TT genotypes

            This polymorphism is proposed to reduced transport into the liver, the main site of statin metabolism and elimination, resulting in elevated plasma concentrations

            SLCO1B1 polymorphism is thought to have a lesser effect on the more hydrophilic statins (eg, rosuvastatin, fluvastatin) compared with more those that are more lipophilic (eg, atorvastatin, pravastatin, simvastatin)

            Other genetic polymorphisms of elimination (eg, CYP450, P-glycoprotein) for each individual drug must also be considered to explain variability for statin clearance among patients that exhibit SCLO1B1 polymorphism

            SLCO1B1 CC genotype is most common in Caucasians and Asians (15%)

            Risk of myopathy is 2.6- to 4.3-fold higher if the C allele is present and 16.9-fold higher in CC homozygotes compared with TT homozygotes

            Genetic testing laboratories

            • Optivia Biotechnology, Inc (http://optiviabio.com/index.html)
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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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