Indications for LIVALO:

Adjunct to diet: To reduce elevated total-C, LDL-C, ApoB, and TG, and to increase HDL-C in primary hyperlipidemia and mixed dyslipidemia. Limitations of use: effect on cardiovascular morbidity and mortality has not been determined. Not studied in Fredrickson Type I, III, and V dyslipidemias.

Adult Dose for LIVALO:

Initially 2mg once daily; may increase after 4 weeks to max 4mg once daily. Moderate to severe renal impairment (CrCl <60mL/min, or ESRD with hemodialysis): 1mg once daily; max 2mg once daily. Concomitant erythromycin: max 1mg daily. Concomitant rifampin: max 2mg daily.

Children's Dose for LIVALO:

Not recommended.

Pharmacological Class:

HMG-CoA reductase inhibitor.

Contraindications:

Active liver disease. Unexplained, persistent elevated serum transaminases. Concomitant cyclosporine. Pregnancy (Cat. X). Nursing mothers.

Warnings/Precautions:

Discontinue if myopathy or markedly elevated CK levels occur; suspend if a predisposition to development of renal failure secondary to rhabdomyolysis develops. Risk factors for myopathy (eg, renal impairment, inadequately treated hypothyroidism, age >65 years, concomitant fibrates, lipid-modifying niacin). Monitor liver function before starting therapy and repeat as clinically indicated. Interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs; do not restart if alternate etiology not found. Substantial alcohol ingestion.

Interactions:

Potentiated by cyclosporine (see Contraindications). Avoid gemfibrozil. Fibrates, niacin increase myopathy risk (consider reducing pitavastatin dose). Potentiated by erythromycin, rifampin (see Adult dose). Monitor warfarin.

Adverse Reactions:

Myalgia, back/extremity pain, GI upset, constipation, elevated creatine phosphokinase, transaminases, alkaline phosphatase, bilirubin, glucose; myopathy, rhabdomyolysis with renal dysfunction, hypersensitivity reactions; rare: cognitive impairment, non-fatal hepatic failure, immune-mediated necrotizing myopathy.

How Supplied:

Tabs—90