Livalo (pitavastatin)

What is Livalo, and how does it work?

Livalo (pitavastatin) is a statin drug used to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels.

Livalo is 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.

What are the side effects of Livalo?

Common side effects of Livalo include:

What is the dosage for Livalo?

General Dosage And Administration Information

  • Take Livalo orally once daily with or without food at the same time each day.
  • Individualize the dose of Livalo according to patient characteristics, goal of therapy, and response.
  • After initiation or upon titration of Livalo, analyze lipid levels after 4 weeks and adjust the dosage accordingly.

Recommended Dosage For Adults And Pediatric Patients Aged 8 Years And Older

  • The recommended starting Livalo dosage is 2 mg once daily.
  • The maximum recommended dosage is Livalo 4 mg once daily.

Recommended Dosage In Patients With Renal Impairment

  • The recommended starting dose for patients with moderate and severe renal impairment (estimated glomerular filtration rate 30 – 59 mL/minute/1.73 m2 and 15 – 29 mL/minute/1.73 m2, respectively) and patients with end-stage renal disease receiving hemodialysis is Livalo 1 mg once daily.
  • The maximum recommended dose for these patients is Livalo 2 mg once daily.

Livalo Dosage Adjustments Due To Drug Interactions

  • In patients taking erythromycin, do not exceed Livalo 1 mg once daily.
  • In patients taking rifampin, do not exceed Livalo 2 mg once daily.

What drugs interact with Livalo?

Drug Interactions That Increase The Risk Of Myopathy And Rhabdomyolysis With Livalo

Table 2 includes a list of drugs that increase the risk of myopathy and rhabdomyolysis when administered concomitantly with Livalo and instructions for preventing or managing drug interactions.

Table 2: Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Livalo

Cyclosporine
Clinical Impact:Cyclosporine significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis.
Intervention: Concomitant use of cyclosporine with Livalo is contraindicated.
Gemfibrozil
Clinical Impact:Gemfibrozil may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of gemfibrozil with statins, including Livalo.
Intervention:Avoid concomitant use of gemfibrozil with Livalo.
Erythromycin
Clinical Impact:Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis.
Intervention:In patients taking erythromycin, do not exceed Livalo 1 mg once daily.
Rifampin
Clinical Impact:Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis.
Intervention:In patients taking rifampin, do not exceed Livalo 2 mg once daily.
Fibrates
Clinical Impact:Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins, including Livalo.
Intervention:Consider if the benefit of using fibrates concomitantly with Livalo outweighs the increased risk of myopathy and rhabdomyolysis.
Niacin
Clinical Impact:The risk of myopathy and rhabdomyolysis may be increased with concomitant use of lipid-modifying doses (≥1 g/day) of niacin with Livalo.
Intervention:Consider if the benefit of using lipid-modifying doses (>1 g/day) of niacin concomitantly with Livalo outweighs the increased risk of myopathy and rhabdomyolysis.
Colchicine
Clinical Impact:Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with statins, including Livalo.
Intervention:Consider the risk/benefit of concomitant use of colchicine with Livalo.

QUESTION

What is cholesterol? See Answer

Is Livalo safe to use while pregnant or breastfeeding?

  • Livalo is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with Livalo during pregnancy.
  • Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Livalo may cause fetal harm when administered to pregnant women. Livalo should be discontinued as soon as pregnancy is recognized.
  • Livalo is contraindicated during breastfeeding. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production.
  • However, it has been shown that another drug in this class passes into human milk. Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with Livalo.

Summary

Livalo (pitavastatin) is a statin drug used to improve blood cholesterol levels in persons with elevated or abnormal blood cholesterol levels. Livalo is 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).

Treatment & Diagnosis

Medications & Supplements

Health Solutions From Our Sponsors

FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

References
FDA Prescribing Information