Dosing

Dosing

(1 mg, 2 mg, 4 mg) - (90 and 500 tablets)

  • The recommended starting dose is 2 mg once daily. Do not exceed 4 mg once-daily dose.
  • After 4 weeks, analyze lipid levels and adjust dosing accordingly.
  • Patients with moderate and 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 Zypitamag 1 mg once daily and a maximum dose of Zypitamag 2 mg once daily.
  • In patients taking erythromycin, a dose of Zypitamag 1 mg once daily should not be exceeded.
  • In patients taking rifampin, a dose of Zypitamag 2 mg once daily should not be exceeded.

Refer to Prescribing Information for complete dosing information and to the Important Safety Information for dose-dependent skeletal muscle effects.

Key considerations outlined in the 2013 ACC/AHA Guidelines and 2014 recommendations published by the National Lipid Association lend credence to an individualised approach to lipid-modifying treatment1,2

  • Assessing patients' individual risks: Evaluate age, comorbidities, and treatment regimens, including complexity, polypharmacy, and potential drug interactions.
  • Determining treatment: Consider statins as first-line drug treatment.
  • Selecting appropriate statin and dose: Discussion with patient to help minimize individual challenges to optimize goal achievement.

Pitavastatin (2 mg, 4 mg) is recommended as a moderate intensity statin. Patient candidates may exist for high-intensity statin but may meet the need for moderate-intensity statin based on the following intensity-modifying criteria.

References:

  1. Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt. B):2889-2934
  2. Jacobson TA, Ito MK, Maki KC, et al. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 1 - executive summary. J Clin Lipidol. 2014;8(5):473-488

IMPORTANT SAFETY INFORMATION FOR ZYPITAMAG™ (pitavastatin)

INDICATIONS & USAGE

Drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate.

Primary Hyperlipidemia and Mixed Dyslipidemia: Zypitamag is indicated as an adjunctive therapy 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) in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Limitations of Use: Doses of Zypitamag greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. Do not exceed 4 mg once daily dosing of Zypitamag. The effect of Zypitamag on cardiovascular morbidity and mortality has not been determined. Zypitamag has not been studied in Fredrickson Type I, III, and V dyslipidemias.

CONTRAINDICATIONS

Zypitamag 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 coadministration with cyclosporine.

WARNINGS & PRECAUTIONS

Skeletal Muscle Effects: Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including pitavastatin.

  • These risks can occur at any dose level, but increase in a dose-dependent manner, with advanced age (≥ 65 years), renal impairment, and inadequately treated hypothyroidism; administer with caution in these patients, or when used concomitantly with fibrates or lipid-modifying doses of niacin, or colchicine. Avoid concomitant administration with gemfibrozil.
  • Advise patients to promptly report unexplained and/or persistent muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever; discontinue Zypitamag.
  • If muscle signs and symptoms persist after discontinuation, this may be a sign of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy associated with statin use, requiring immediate medical attention. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment; muscle biopsy showing necrotizing myopathy without significant inflammation; improvement with immunosuppressive agents.
  • Zypitamag should be discontinued if markedly elevated creatine kinase levels occur or myopathy is diagnosed or suspected.
  • Zypitamag should also be temporarily withheld in any patient with an acute, serious condition suggestive of myopathy or predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis, hypotension, dehydration, major surgery, trauma, severe metabolic, endocrine, and electrolyte disorders, or uncontrolled seizures).

Liver Enzyme Abnormalities:

  • Persistent elevation in hepatic transaminases can occur. Check liver enzymes before initiating therapy and if signs or symptoms of liver injury occur; advise patients to report fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
  • Fatal and non-fatal hepatic failure can occur. Interrupt Zypitamag if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs. If an alternate etiology is not found do not restart Zypitamag.
  • Use Zypitamag with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease. Do not use Zypitamag if patient has active liver disease, which may include unexplained persistent transaminase elevations.

Endocrine Function:

  • Increases in HbA1c and fasting serum glucose levels have been reported.

COMMON ADVERSE REACTIONS

Myalgia, back pain, diarrhea, constipation and pain in extremity (rate ≥ 2% in at least one marketed dose). This is not a complete list of all reported adverse events.

For additional information, refer to full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch
or call 1-800-FDA-1088