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Pitavastatin

    Brands

    DEA Class; Rx

    Common Brand Names; Livalo, Zypitamag

    • Lipid-Lowering Agents, Statins; 
    • HMG-CoA Reductase Inhibitors

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

    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)

    Indicated for heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in children aged ≥8 years

    Hypersensitivity to drug or excipients

    Active liver disease or persistent unexplained elevations of hepatic transaminases

    Concurrent use with cyclosporine

    Back pain (1.4-3.9%)

    Constipation (1.5-3.6%)

    Diarrhea (1.5-2.6%)

    Myalgia (1.9-3.1%)

    Pain in extremity (0.6-2.3%)

    Gastrointestinal disorders: Abdominal discomfort, abdominal pain, dyspepsia, nausea

    General disorders: Asthenia, fatigue, malaise, dizziness

    Hepatobiliary disorders: Hepatitis, jaundice, fatal and nonfatal hepatic failure

    Immune system disorders: Immune-mediated necrotizing myopathy-associated with statin use; angioedema

    Metabolism and nutrition disorders: Increases in HbA1c, fasting serum glucose levels

    Musculoskeletal and connective tissue disorders: Muscle spasms, myopathy, rhabdomyolysis

    Nervous system disorders: Hypoesthesia, peripheral neuropathy

    Psychiatric disorders: Insomnia, depression; rare reports of cognitive impairment (eg, memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use; cognitive impairment was generally nonserious, and reversible upon discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks)

    Reproductive system and breast disorders: Erectile dysfunction

    Respiratory, thoracic and mediastinal disorders: Interstitial lung disease

    Skin and subcutaneous tissue disorders: Lichen planus

    Increased HbA1c and fasting serum glucose levels reported with statins; optimize lifestyle measures, including regular exercise, maintaining healthy body weight, and making healthy food choices

    Owing to HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, fetal harm may occur when administered to pregnant females

    There is no available information about prescence of pitavastatin in human or animal milk, effects of drug on breastfed infant, or on milk production

    Adults

    Primary Hyperlipidemia and Mixed Dyslipidemia Adjunct 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

    Pediatric

    Heterozygous Familial Hypercholesterolemia

    Livalo only

    Indicated for heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in children aged ≥8 years

    <8 years: Safety and efficacy not established

    ≥8 years

    • Recommended starting dose: 2 mg PO qDay
    • May increase to 4 mg PO qDay if necessary

    Livalo is the calcium salt of pitavastatin

    Zypitamag is the magnesium salt of pitavastatin

    tablet

    • 1mg
    • 2mg
    • 4mg