pitavastatin (Rx)

Brand and Other Names:Livalo, Zypitamag, more...Nikita
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Livalo is the calcium salt of pitavastatin

Zypitamag is the magnesium salt of pitavastatin

Nikita is the sodium salt of pitavastatin

tablet

  • 1mg
  • 2mg
  • 4mg

Hypercholesterolemia

Indicated for primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C)

Recommended starting dose: 2 mg PO qDay

May increase to 4 mg PO qDay if necessary

Dosage Modifications

Interactions

  • Coadministration with erythromycin: Not to exceed pitavastatin 1 mg/day
  • Coadministration with rifampin: Not to exceed pitavastatin 2 mg/day

Renal impairment

  • Moderate-to-severe (CrCl 15-60 mL/min/1.73 m²) or ESRD: 1 mg PO qDay initially; not to exceed 2 mg/day

Hepatic impairment

  • Contraindicated in active liver disease or unexplained transaminase elevations

Safety and efficacy not established

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Interactions

Interaction Checker

and pitavastatin

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Constipation

            Diarrhea

            Back pain

            Joint pain

            Myalgias

            Myopathy

            Rhabdomyolysis

            Increased alkaline phosphatase

            Increased bilirubin

            Increased CPK

            Increased blood glucose

            Reversible amnesia

            Memory impairment

            Hyperglycemia

            Confusion

            Pruritus

            Urticaria

            Rash

            Nasopharyngitis

            Postmarketing Reports

            Abdominal discomfort, abdominal pain, dyspepsia, nausea, asthenia, fatigue, malaise, hepatitis, jaundice, fatal and non-fatal hepatic failure, dizziness, hypoesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction, muscle spasms and peripheral neuropathy

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            Warnings

            Contraindications

            Hypersensitivity

            Active liver disease or persistent unexplained elevations of hepatic transaminases

            Pregnancy

            Breastfeeding

            Concurrent use wit cyclosporine

            Cautions

            Non-serious and reversible cognitive side effects may occur

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

            Caution in history of liver or renal impairment

            If symptoms of hepatotoxicity (hyperbilirubinemia or jaundice) occurs, discontinue therapy; if no alternate etiology explains the symptoms do not restart therapy

            Heavy alcohol use

            Risk of rhabdomyolysis

            Myopathy, risk of myopathy increases when coadministered with fibrates, niacin, cyclosporine, colchicine, and CYP2C9 inhibitors (eg, fluconazole, gemfibrozil, nevirapine, sulfisoxazole)

            Withhold or discontinue if myopathy develops, renal failure, or transaminase levels >3x ULN

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

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            Pregnancy & Lactation

            Pregnancy

            Contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy during pregnancy; therapy should be discontinued as soon as pregnancy is recognized

            May cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during therapy

            Lactation

            Contraindicated during breastfeeding; there is no available information on effects of drug on breastfed infant or effects of drug on milk production; however, another drug in this class passes into human milk; because of potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment

            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.

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            Pharmacology

            Mechanism of Action

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

            Absorption

            Bioavailability: 51%

            Peak plasma time: 1 hr

            Onset: 2-4 weeks

            Distribution

            Protein binding: >99%

            Metabolism

            Metabolism: Hepatic via UGT1A3 and UGT2B7; minimally through CYP2C9 and OATP1B1

            Elimination

            Half-life: 12 hr

            Excretion: Feces (79%); urine (15%)

            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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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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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.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.