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Important Safety Information
Full Prescribing Information
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Dear Healthcare Professional,
As healthcare professionals who treat patients with high cholesterol, it is important that we share data that can positively impact the treatment of our patients. That’s why I am excited to provide you with clinical data for LIVALO from a head-to-head non-inferiority
trial vs Lipitor® (atorvastatin calcium).
Please see below some highlights from a clinical trial in which LIVALO demonstrated LDL-C reductions comparable to commonly prescribed doses of Lipitor.1,2 Common adverse reactions include myalgia. I invite you to see how LIVALO compares to Lipitor and to consider LIVALO for appropriate patients who raise concerns about their statin. Please share this important clinical information with your colleagues.
Michael G. Clark, DMSc, PhD, PA-C, MPAS, AACC, DFAAPA
LIVALO is a HMG-CoA reductase inhibitor indicated as an adjunctive therapy to diet. The effect of LIVALO on cardiovascular morbidity and mortality has not been determined.
In a non-inferiority clinical trial of adult patients,
LIVALO demonstrated LDL-C reductions comparable to commonly prescribed doses of Lipitor1,2
Mean % Change in Lipid Parameters at Week 12*†1,2
LIVALO has also been evaluated head-to-head vs Lipitor in a clinical trial of patients with type 2 diabetes.‡1,3
* Non-inferiority of pitavastatin to a given dose of atorvastatin calcium was considered demonstrated if the lower bound of the 95% CI for the mean treatment difference was greater than -6% for the mean percent change in LDL-C.1,2
Study 301: 12-week, randomized, multicenter, double-blind, double-dummy, active-controlled, non-inferiority, Phase 3 study in adult patients with primary hyperlipidemia or mixed dyslipidemia comparing pitavastatin 2 mg (n=315) and 4 mg (n=298) with atorvastatin calcium 10 mg (n=102) and 20 mg (n=102), respectively.
Study 305: 12-week, randomized, multicenter, double-blind, double-dummy, parallel-group, active-controlled, non-inferiority, Phase 3 study of pitavastatin vs atorvastatin calcium in 410 adult patients with combined dyslipidemia and type 2 diabetes mellitus. Mean percent change from baseline in LDL-C at Week 12 was -41% (pitavastatin 4 mg) vs -43% (atorvastatin calcium 20 mg). Treatment difference (95% CI) in adjusted mean percent change in LDL-C was -2% (-6.2%, 1.5%), P=0.235. However, the -6.2% lower limit of CI slightly exceeded the -6% non-inferiority limit. The study failed to demonstrate that LIVALO was not significantly different than atorvastatin calcium in lowering LDL-C in patients with type 2 diabetes mellitus and mixed dyslipidemia.1,3
See how LIVALO compares to Lipitor and why LIVALO may be an appropriate consideration when patients raise concerns about their statin.
See the Data
Find out how to receive samples of LIVALO 2 mg and 4 mg.
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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:
•  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).
•  Pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated TC, LDL-C, and Apo B.
Limitations of Use
•  The effect of LIVALO on cardiovascular morbidity and mortality has not
been determined.
•  Known hypersensitivity to product components.
•  Coadministration with cyclosporine.
•  Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels.
•  Pregnancy.
•  Lactation.
Warnings and Precautions
•  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.
•  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.
•  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.
•  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.
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.
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
Lipitor is a registered trademark of Pfizer Inc.
1.  LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; September 2020.
2.  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.
3.  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.
LIVALO is a registered trademark of the Kowa group of companies.
© Kowa Pharmaceuticals America, Inc. (2021)
All rights reserved. LIV-MT-4216 June 2021
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