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Important Safety Information for LIVALO® (pitavastatin) tablets |
Indications and Usage |
LIVALO is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet in: |
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Adult patients with primary hyperlipidemia or mixed dyslipidemia 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). |
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Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B. |
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Limitations of Use |
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The effect of LIVALO on cardiovascular morbidity and mortality has not been determined. |
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Contraindications |
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Known hypersensitivity to product components. |
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Coadministration with cyclosporine. |
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Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. |
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Pregnancy. |
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Lactation. |
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Warnings and Precautions |
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Myopathy and Rhabdomyolysis: Risk factors include age 65 and greater, renal impairment, inadequately treated hypothyroidism, concomitant use of certain drugs, and higher doses of LIVALO. LIVALO is contraindicated in patients taking cyclosporine and not recommended in patients taking gemfibrozil. The following drugs when used concomitantly with LIVALO may also increase the risk of myopathy and rhabdomyolysis: lipid-modifying dosages of niacin (>1 grams/ day), fibrates, and colchicine. Discontinue LIVALO if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Temporarily discontinue LIVALO in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis; e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. Inform patients of the risk of myopathy and rhabdomyolysis when starting or increasing the LIVALO dosage. Instruct patients to promptly report any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever. |
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Immune-Mediated Necrotizing Myopathy (IMNM): There have been rare reports of IMNM, an autoimmune myopathy, associated with statin use. IMNM is characterized by: proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; positive anti-HMG CoA reductase antibody; muscle biopsy showing necrotizing myopathy; and improvement with immunosuppressive agents. |
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Hepatic Dysfunction: Increases in serum transaminases can occur. Rare postmarketing reports of fatal and non-fatal hepatic failure have occurred. Consider liver enzyme testing before initiating therapy and as clinically indicated thereafter. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue LIVALO. |
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Increases in HbA1c and Fasting Serum Glucose Levels: Increases of each have been reported with statins, including LIVALO. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices. |
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Adverse Reactions |
In short-term controlled studies, the most frequent adverse reactions reported by ≥2% of patients treated with LIVALO 1 mg, 2 mg, and 4 mg, respectively, and at a rate ≥ placebo were back pain (3.9%, 1.8%, 1.4% vs 2.9%), constipation (3.6%, 1.5%, 2.2% vs 1.9%), diarrhea (2.6%, 1.5%, 1.9% vs 1.9%), myalgia (1.9%, 2.8%, 3.1% vs 1.4%), and pain in extremity (2.3%, 0.6%, 0.9% vs 1.9%). Other serious adverse reactions include rhabdomyolysis, immune-mediated necrotizing myopathy, hepatic dysfunction, and increases in HbA1c and fasting serum glucose. In adult HIV-infected patients with dyslipidemia, the safety profile of LIVALO was generally consistent with that observed in the short-term controlled studies described above. In pediatric patients with HeFH, the safety profile was similar to that observed in the adult population. This is not a complete listing of all reported adverse events. |
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For additional information please see the full Prescribing Information or visit www.LivaloHCP.com. |
© Kowa Pharmaceuticals America, Inc. (2021) - LIV-RA-0141 PI V-09-2020 |
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Lipitor is a registered trademark of Pfizer Inc. |
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References: |
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LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; September 2020. |
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Budinski D, Arneson V, Hounslow N, Gratsiansky N. Pitavastatin compared with atorvastatin in primary hypercholesterolemia or combined dyslipidemia. Clin Lipidol. 2009;4(3):291-302. |
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Gumprecht J, Gosho M, Budinski D, Hounslow N. Comparative long-term efficacy and tolerability of pitavastatin 4 mg and atorvastatin 20–40 mg in patients with type 2 diabetes mellitus and combined (mixed) dyslipidemia. Diabetes Obes Metab. 2011;13(11):1047-1055. |
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