INDICATIONS AND 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

LIVALO 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 HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia.

LIMITATIONS OF USE

  • Doses of LIVALO 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 LIVALO
  • The effect of LIVALO on cardiovascular morbidity and mortality has not been determined
  • LIVALO has not been studied in patients with severe renal impairment (glomerular filtration rate <30 mL/min/1.73 m2) not on hemodialysis. LIVALO should not be used in this patient population
  • LIVALO has not been studied with the protease inhibitor combination lopinavir/ritonavir. LIVALO should not be used with this combination of protease inhibitors
  • LIVALO has not been studied in Fredrickson Type I, III, and V dyslipidemias

IMPORTANT SAFETY INFORMATION

Contraindications

  • LIVALO 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

Skeletal Muscle Effects

  • Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with HMG-CoA reductase inhibitors, including LIVALO
  • The risk of skeletal muscle effects (eg, myopathy and rhabdomyolysis) increases in a dose-dependent manner with advanced age (>65 years), renal impairment, inadequately treated hypothyroidism, and in combination use with fibrates or lipid-modifying doses of niacin
  • LIVALO therapy should be discontinued if markedly elevated CK levels occur or myopathy is diagnosed or suspected. LIVALO therapy 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 (eg, sepsis; hypotension; dehydration; major surgery; trauma; severe metabolic, endocrine, and electrolyte disorders; or uncontrolled seizures)
  • Advise patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, and to discontinue LIVALO if these signs or symptoms appear

Liver Enzyme Abnormalities and Monitoring

  • It is recommended that liver enzyme tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose and periodically (eg, semiannually) thereafter
  • Should an increase in ALT or AST of >3 times upper limit of normal persist, reduction of dose or withdrawal of LIVALO is recommended
  • LIVALO should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease

Adverse Reactions

  • The most frequent adverse reactions (rate ≥2.0% in at least one marketed dose) were myalgia, back pain, diarrhea, constipation, and pain in extremity