Livalo (pitavastatin)

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.

Common side effects of Livalo include:

• muscle pain,
• back pain,
• joint pain,
• pain in your arms and legs,
• diarrhea,
• constipation,
• skin rash,
• headache,
• sore throat,
• stuffy or runny nose, and
• flu symptoms.

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.

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

• 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.