Indications for: LIVALO
Adjunct to diet: to reduce elevated total-C, LDL-C, ApoB, and TG, and to increase HDL-C in adults with primary hyperlipidemia or mixed dyslipidemia; or to reduce elevated total-C, LDL-C, and ApoB in children with heterozygous familial hypercholesterolemia (HeFH).
Limitations of Use:
Effect on cardiovascular morbidity and mortality has not been determined.
Adults and Children:
<8yrs: not established. Individualize. ≥8yrs: Initially 2mg once daily; may increase after 4 weeks to max 4mg once daily. Moderate to severe renal impairment (eGFR <60mL/min/1.73m2, or ESRD with hemodialysis): 1mg once daily; max 2mg once daily. Concomitant erythromycin: max 1mg once daily. Concomitant rifampin: max 2mg once daily.
Active liver disease. Unexplained, persistent elevated hepatic transaminases. Concomitant cyclosporine. Pregnancy. Nursing mothers.
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, uncontrolled hypothyroidism, age ≥65yrs). Immune-mediated necrotizing myopathy; monitor. Monitor liver function prior to initiation and repeat as clinically indicated. Discontinue if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs. Substantial alcohol ingestion. Advise females of reproductive potential to use effective contraception during treatment.
HMG-CoA reductase inhibitor.
Potentiated by cyclosporine (see Contraindications), erythromycin, and rifampin (see Adults and Children). Avoid gemfibrozil. Increased risk of myopathy with concomitant fibrates, colchicine, niacin (≥1g/day); consider risk vs benefit.
Myalgia, back/extremity pain, diarrhea, constipation, elevated creatine phosphokinase, transaminases, alkaline phosphatase, bilirubin; myopathy, rhabdomyolysis with renal dysfunction, hypersensitivity reactions, increases HbA1c and fasting serum glucose levels; rare: fatal/non-fatal hepatic failure.
Generic Drug Availability: