Prescribing LIVALO

Dosing

LIVALO is available in once-daily doses of 1 mg, 2 mg, or 4 mg1

  • Recommended starting dose is 2 mg once daily, which provides a 39% mean LDL-C reduction. When titrating to 4 mg, LIVALO provides a 45% mean LDL-C reduction. Do not exceed 4-mg once-daily dosing 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 considerations1

  • 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
  • Patients with moderate or severe renal impairment not on hemodialysis (eGFR 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
  • Current guidelines recommend moderate-intensity statin therapy in patients with CKD who are age 40-75 years with LDL-C 70 to 189 mg/dL and 10-year ASCVD risk ≥7.5%.2

eGFR=estimated glomerular filtration rate. CKD=chronic kidney disease. ASCVD=atherosclerotic cardiovascular disease.

No Contraindications with Certain Medications

LIVALO has no contraindications, dose restrictions, or limitations with certain medications, including1:

Ezetimibe: Cholesterol absorption inhibitor

Diltiazem LA: Calcium channel blocker

Itraconazole: Azole antifungal

Warfarin: Anticoagulant (PT and INR should still be routinely monitored)

Enalapril: Angiotensin-converting enzyme inhibitor

Digoxin: Cardiac glycoside

Grapefruit Juice

Atazanavir: HIV protease inhibitor

Lopinavir/Ritonavir: HIV protease inhibitors

Darunavir/Ritonavir: HIV protease inhibitors

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

Warfarin

  • LIVALO 4 mg daily had no significant effect on PT or INR
  • Co-administration of LIVALO did not result in 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/ritonavir
  • 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.

Clinical Trial Data

When patients complain about their statin,

The moderate intensity of LIVALO makes it your go-to 2nd-line statin

LIVALO demonstrated:

  • Potent LDL-C reduction up to a mean of 45% at the 4-mg dose*1,3-5
  • According to the ACC/AHA Guidelines on statin intensity, moderate-intensity statins provide average LDL-C reductions of ~30% to <50%2
  • Improvements in other lipid parameters, including Apo B, Non-HDL-C, HDL-C, and TG1,3-5
  • Comparable efficacy at the 2-mg and 4-mg doses to commonly prescribed strengths of Lipitor® (atorvastatin) (10 mg, 20 mg) and Zocor® (simvastatin) (20 mg, 40 mg)†1-3
  • Statistically superior LDL-C reductions compared to Pravachol® (pravastatin) based on 3 pairwise comparisons‡1,5

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

Lipitor is a registered trademark of Pfizer, Inc.

Zocor is a registered trademark of Merck & Co., Inc.

Pravachol is a registered trademark of Bristol-Myers Squibb Company.

*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 pitavastatin 2 mg (-38%, -39%, -39%) and 4 mg (-45%, -44%, -44%).

Pitavastatin was not studied against atorvastatin 40-mg and 80-mg doses or simvastatin 80-mg dose.

Pitavastatin was not studied against pravastatin 80-mg dose.

Safety

LIVALO is a demonstrated safe and tolerable statin1

of patients taking LIVALO 4 mg experienced myalgia in pivotal trials

Only

patients discontinued LIVALO 4 mg due to myalgia

discontinuation rates with LIVALO; not dose dependent

Find LIVALO coverage in your area

  1. LIVALO [prescribing information]. Montgomery, AL: Kowa Pharmaceuticals America, Inc.; November 2016.
  2. Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2018; https://www.ahajournals.org/doi/suppl/10.1161/CIR.0000000000000625.
  3. 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.
  4. Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia [published correction appears in Curr Med Res Opin. 2010;26(5):1046]. Curr Med Res Opin. 2009;25(11):2755-2764.
  5. Stender S, Budinski D, Gosho M, Hounslow N. Pitavastatin shows greater lipid-lowering efficacy over 12 weeks than pravastatin in elderly patients with primary hypercholesterolaemia or combined (mixed) dyslipidaemia. Eur J Prev Cardiol. 2013;20(1):40-53.
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