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.

The effect of LIVALO on cardiovascular morbidity and mortality has not been determined.

LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias.

LIVALO may cause myopathy (muscle pain, tenderness, or weakness with creatine kinase (CK) above ten times the upper limit of normal) and rhabdomyolysis (with or without acute renal failure secondary to myoglobinuria). Rare fatalities have occurred as a result of rhabdomyolysis with statin use, including LIVALO.

Risk factors for myopathy include age 65 years or greater, uncontrolled hypothyroidism, renal impairment, concomitant use of certain drugs, and higher LIVALO dosage. Dosages of LIVALO greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. The maximum recommended dose of LIVALO is 4 mg once daily.

Discontinue LIVALO if markedly elevated CK levels occur or myopathy is diagnosed or suspected. Muscle symptoms and CK increases may resolve if LIVALO is discontinued. Temporarily discontinue LIVALO in patients experiencing an acute or serious condition at high risk of developing renal failure secondary to rhabdomyolysis, e.g., sepsis; shock; severe hypovolemia; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy.

Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including LIVALO.

There have been rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, associated with statin use.

Increases in HbA1c and fasting serum glucose levels have been reported with statins, including LIVALO.

Increases in serum transaminases have been reported with LIVALO.

There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients taking statins, including LIVALO. Patients who consume substantial quantities of alcohol and/or have a history of liver disease may be at increased risk for hepatic injury. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue LIVALO.

LIVALO should be used with caution in patients who consume substantial quantities of alcohol.

Consider liver enzyme testing before the initiation of LIVALO and thereafter, when clinically indicated. LIVALO is contraindicated in patients with active liver disease including unexplained persistent elevations in hepatic transaminase levels. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue LIVALO.

LIVALO is contraindicated in the following condition:

• Concomitant use of cyclosporine
• Active liver disease including unexplained persistent elevations of hepatic transaminase levels
• pregnancy
• Lactation. It is not known if pitavastatin is present in human milk; however, another drug in this class passes into breast milk. Since HMG-CoA reductase inhibitors have the potential for serious adverse reactions in breastfed infants, females who require pitavastatin treatment should not breastfeed their infants
• Known hypersensitivity to pitavastatin or any inactive ingredient in LIVALO. Hypersensitivity reactions including angioedema, rash, pruritus, and urticaria have been reported with LIVALO

Concomitant administration of LIVALO with gemfibrozil should be avoided.

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.

Erythromycin significantly increases pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. In patients taking erythromycin, a dose of LIVALO 1 mg once daily should not be exceeded.

Rifampin significantly increases peak pitavastatin exposure and increases the risk of myopathy and rhabdomyolysis. In patients taking rifampin, a dose of LIVALO 2 mg once daily should not be exceeded.

Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins, including LIVALO.

The risk of myopathy and rhabdomyolysis may be increased with  concomitant use with niacin.

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.

LIVALO is contraindicated during breastfeeding.

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• Use in HIV patients to reduce inflammatory response. GoToSource

• Melanoma, breast cancer and colon cancer. GoToSource

• Use in patients under 8 years of age. GoToSource

• Dosage greater than 4 mg daily in patients without renal impairment. GoToSource

• Idiopathic pulmonary fibrosis. GoToSource

• Improve post-stroke recovery. GoToSource

• Rheumatoid arthritis. GoToSource

• Venous thromboembolism. GoToSource

Myalgias (pain in a muscle or group of muscles) and myopathy, including rhabdomyolysis (disease of muscle tissue). GoToSource

Jaundice, hepatitis and liver failure including fatal cases. GoToSource

Interstitial lung disease (disorder causing scarring of the lungs). GoToSource

Cognitive impairment (memory loss, forgetfulness, amnesia, memory impairment, confusion). GoToSource

Necrotizing autoimmune myopathy. GoToSource

New-onset type 2 diabetes mellitus. GoToSource

Lawsuits filed for muscle damage, myopathy, rhabdomyolysis, kidney failure, type 2 diabetes and death.