WITH THE LIVALO SAVINGS CARD:

Eligible patients
may pay as little as
$18a month>
*Certain rules and restrictions apply.
Get In The Know With Livalo

Explore our easy-to-use, self-guided tool that can give you the information you need to know about the benefits of LIVALO!

Get To Know Livalo

As you know, every patient is unique, and one statin won’t fit all patients. For certain patients requiring statin therapy, LIVALO may be the right choice.

Get To Know Livalo

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METABOLISM

LIVALO® is only minimally metabolized via the CYP450 system1

ZOOM Crowded metabolic pathway and drug interactions Crowded metabolic pathway and drug interactions
  • Based on its metabolism, LIVALO may have reduced potential for clinically significant drug interactions mediated by the CYP450 system1,7,8
    • The principal route of LIVALO metabolism is conjugation with glucuronic acid via liver UGTs with subsequent formation of pitavastatin lactone
  • No dose adjustment necessary when taken with calcium channel blockers, HIV protease inhibitors, the anticoagulant warfarin, or the antifungal itraconazole1
CYP450=cytochrome P450. UGT=uridine 5'-diphosphate (UDP) glucuronosyltransferase.
Drug Interactions
  • Cyclosporine. Co-administration is contraindicated
  • Erythromycin. Do not exceed a 1-mg dose of LIVALO once daily
  • Rifampin. Do not exceed a 2-mg dose of LIVALO once daily
  • Gemfibrozil. Use with gemfibrozil should be avoided
  • Other fibrates. Co-administration with fenofibrate did not result in a significant increase in AUC or Cmax of LIVALO; however, HMG-CoA reductase inhibitors like LIVALO should be used with caution with fibrates due to the increased risk of myopathy
  • Niacin (≥1 g/day). A reduction in LIVALO dosage should be considered due to potential risk of skeletal muscle effects
  • Colchicine. Cases of myopathy, including rhabdomyolysis, have been reported with HMG-CoA reductase inhibitors coadministered with colchicine, and caution should be exercised when prescribing LIVALO with colchicine
AUC=area under the curve. Cmax=maximum concentration observed.
  • References:
  • 1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  • 2. Atorvastatin (Lipitor) [prescribing information]. New York, NY: Pfizer, Inc.; March 2015.
  • 3. Simvastatin (Zocor) [prescribing information]. Whitehouse Station, NJ: Merck & Co., Inc.; March 2015.
  • 4. Statin Market TRx by Year. Symphony Health Solutions data as of the end of October, 2015.
  • 5. Guengerich FP. Cytochrome P450 and chemical toxicology. Chem Res Toxicol. 2008;21(1):70-83.
  • 6. Huang SM, Temple R, Throckmorton DC, Lesko LJ. Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Clin Pharmacol Ther. 2007;81(2):298-304.
  • 7. Neuvonen PJ. Drug interactions with HMG-CoA reductase inhibitors (statins): the importance of CYP enzymes, transporters and pharmacogenetics. Curr Opin Investig Drugs. 2010;11(3):323-332.
  • 8. Corsini A, Ceska R. Drug-drug interactions with statins: will pitavastatin overcome the statins’ Achilles’ heel? Curr Med Res Opin. 2011;27(8):1551-1562.
METABOLISM↑

THE REALITY OF POLYPHARMACY

The reality of polypharmacy:
Managing multiple medications is a real challenge

In the largest survey of statin users ever conducted in the United States, there were 10,138 respondents. 1,220 respondents were former statin users and 8,918 were current users.1

  • Drug interaction potential
    8 out of 101(84%)
    • 84% of all respondents used at least one prescription, OTC, or herbal/vitamin product — which may have the potential for DDIs1
    • DDIs are a potential risk factor for clinically significant side effects2,3
    • Of those respondents, patients used on average 3 products with statin interaction potential1
    • Only 26% proactively spoke to their doctor about the possibility of their medications interfering with each other1
  • Stopped statins due to side effects
    62%
    • Of former statin users*, more than 6 in 10 (62%) stopped their statin due to side effects, such as muscle pain and/or weakness1
    • Muscle-related side effects were reported by 60% of former statin users and 25% of current users1
    OTC=over-the-counter. DDI=drug-drug interaction.
    *Of the 10,138 respondents 1,220 were former statin users. 8,918 were current users.

Fear of side effects

53% 53% of patients reported fear of side effects as a reason for not filling their initial statin prescription.†4

According to a study published on statin non-adherence.

  • References:
  • 1. Cohen JD, Brinton EA, Ito MK, Jacobson TA. Understanding Statin Use in America and Gaps in Patient Education (USAGE): an internet-based survey of 10,138 current and former statin users. J Clin Lipidol. 2012;6(3):208-215.
  • 2. Corsini A, Ceska R. Drug-drug interactions with statins: will pitavastatin overcome the statins’ Achilles’ heel? Curr Med Res Opin. 2011;27(8):1551-1562.
  • 3. Huang SM, Temple R, Throckmorton DC, Lesko LJ. Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Clin Pharmacol Ther. 2007;81(2):298-304.
  • 4. Harrison TN, Derose SF, Cheetam TC, et al. Primary nonadherence to statin therapy: patients’ perceptions. Am J Manag Care. 2013;19(4):e133-e139.
THE REALITY OF POLY-PHARMACY↑

LIVALO EFFICACY

DISTINCTLY DIFFERENT with the proven efficacy you expect from a potent statin

LIVALO® DEMONSTRATED:

  • Potent LDL-C reduction up to a mean of 45% at the 4-mg dose*1-4
  • Improvements in other lipid parameters, including Non-HDL-C, HDL-C, Apo B, and TG1-4
  • Comparable efficacy at the 2-mg and 4-mg doses to commonly prescribed strengths of atorvastatin (10 mg, 20 mg) and simvastatin (20 mg, 40 mg)†1-3
  • Statistically superior LDL-C reductions compared to pravastatin based on three pairwise dose comparisons‡1,4
*Based on the mean change from baseline in LDL-C observed in three 12-week, randomized, multicenter, double-blind, double-dummy, Phase 3 studies in patients with primary hyperlipidemia or mixed dyslipidemia taking LIVALO 2 mg (-38%, -39%, -39%) and 4 mg (-45%, -44%, -44%). LIVALO was not studied against atorvastatin 40-mg and 80-mg doses or simvastatin 80-mg dose. LIVALO was not studied against pravastatin 80-mg dose.

CONTRAINDICATIONS

LIVALO is contraindicated in patients with a known hypersensitivity to product components, in patients with active liver disease (which may include unexplained persistent elevations in hepatic transaminase levels), in women who are pregnant or may become pregnant, in nursing mothers, or in co-administration with cyclosporine.

§Based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III criteria.5
STUDY DESIGN↓

Three 12-week, randomized, multicenter, double-blind, double-dummy, non-inferiority, Phase 3 studies in patients with primary hyperlipidemia or mixed dyslipidemia: Study 301: LIVALO 2 mg (n=315) and 4 mg (n=298); Study 302: LIVALO 2 mg (n=307) and 4 mg (n=319); Study 306: in patients ≥65 years, LIVALO 1 mg (n=207), 2 mg (n=224), and 4 mg (n=210).

DRUG INTERACTION/PK STUDIES, DOSING, SAFETY & DISCONTINUATION RATES

Drug Interaction/PK Studies, Dosing, Safety & Discontinuation Rates

Drug Interaction/PK Studies

No Dosing Adjustment Recommended in Combination With1:

Diltiazem LA

  • Co-administration with diltiazem LA did not result in clinically significant changes in the AUC or Cmax for either drug

Itraconazole

  • Co-administration with itraconazole, an antifungal, did not result in clinically significant changes in the AUC or Cmax for LIVALO

Fibrates

  • Use with gemfibrozil should be avoided
  • Co-administration with fenofibrate did not result in clinically significant changes in the AUC or Cmax of LIVALO; however, HMG-CoA reductase inhibitors like LIVALO should be used with caution with fibrates due to the increased risk of myopathy

Warfarin

  • LIVALO 4 mg daily had no significant effect on PT/INR
  • Co-administration of LIVALO did not result in clinically significant changes in the AUC or Cmax of warfarin. Patients receiving warfarin should have their PT and INR monitored when pitavastatin is added to their therapy

Enalapril

  • Co-administration with enalapril, an ACE inhibitor, did not result in clinically significant changes in the AUC or Cmax for either drug

Digoxin

  • Co-administration with digoxin did not result in clinically significant changes in the AUC or Cmax for either drug

HIV protease inhibitors

  • Atazanavir, lopinavir/ritonavir, or darunavir
  • Co-administration with these drugs did not result in clinically significant changes in the AUC or Cmax of LIVALO

Grapefruit juice

  • Co-administration with grapefruit juice did not result in clinically significant changes in the AUC or Cmax of LIVALO
PT=prothrombin time. INR=international normalized ratio. AUC=area under the curve. Cmax=maximum concentration observed.

Dosing

LIVALO® DOSING INFORMATION:

  • LIVALO is available in once-daily doses of 1 mg, 2 mg, or 4 mg
  • Recommended starting dose is 2 mg once daily. Do not exceed 4-mg once-daily dosing of LIVALO
  • After initiation or upon titration of LIVALO, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly
  • LIVALO can be taken with or without food, at any time of day

Special dosing considerations:

  • Patients with moderate or severe renal impairment not on hemodialysis (GFR 30-59 mL/min/1.73 m2 and 15-29 mL/min/1.73 m2, respectively) and patients with end-stage renal disease on hemodialysis should receive a starting dose of LIVALO 1 mg once daily and a maximum dose of LIVALO 2 mg once daily
  • In patients taking erythromycin, a dose of LIVALO 1 mg once daily should not be exceeded
  • In patients taking rifampin, a dose of LIVALO 2 mg once daily should not be exceeded
Clinical Safety & Tolerability

LIVALO ADVERSE REACTIONS AS COMPARED WITH PLACEBO1

Adverse Reactions Reported by ≥2% of Patients Treated with LIVALO and ≥Placebo in Short-term Controlled Studies Lasting Up to 12 Weeks1
Adverse reaction Placebo
N=208
LIVALO 1 mg
N=309
LIVALO 2 mg
N=951
LIVALO 4 mg
N=1540
Back pain 2.9% 3.9% 1.8% 1.4%
Constipation 1.9% 3.6% 1.5% 2.2%
Diarrhea 1.9% 2.6% 1.5% 1.9%
Myalgia 1.4% 1.9% 2.8% 3.1%
Pain in extremity 1.9% 2.3% 0.6% 0.9%
DISCONTINUATION RATES

LIVALO discontinuation rates are less than 4% and not dose dependent1

  • Discontinuation rates due to adverse reactions were similar across all doses, in controlled, short-term clinical studies and their open-label extensions from 44-60 weeks1
    • The most common adverse reactions that led to treatment discontinuation were elevated creatine phosphokinase (0.6% on 4 mg) and myalgia (0.5% on 4 mg)
LIVALO Dose Discontinuation Rate
1 mg 3.9%
2 mg 3.3%
4 mg 3.7%
  • Reference:
  • 1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
DRUG INTERACTION STUDIES, DOSING, & SAFETY↑

Eligible patients may pay as little as $18 PER MONTH*

Help your patients save on LIVALO®

COPAY CARD

Eligible patients may pay as little as $18 a month!*

Our LIVALO® Savings Card:

  • Covers up to $75 monthly on out-of-pocket costs on each 30-day supply.
  • Can be used with mail-order prescriptions.
  • Can be used with all strengths (1 mg, 2 mg, and 4 mg).
HELP YOUR PATIENTS SAVE *Certain rules and restrictions apply. Please see eligibility criteria, along with offer terms and details, on the LIVALO Savings Card.
Eligible patients may pay as little as $18 PER MONTH↑