Generic Name and Formulations:
Pitavastatin 1mg, 2mg, 4mg; tabs.
Kowa Pharmaceuticals America, Inc.
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:
Do not exceed 4mg once daily dosing. Effect on cardiovascular morbidity and mortality has not been determined. Not studied in Fredrickson Type I, III, and V dyslipidemias.
Individualize. 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.
Active liver disease. Unexplained, persistent elevated serum 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, inadequately treated hypothyroidism, age ≥65yrs). Monitor liver function prior to initiation 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. Females of reproductive potential should use effective contraception during treatment.
Potentiated by cyclosporine (see Contraindications). Avoid gemfibrozil. Increased risk of myopathy with concomitant fibrates, colchicine, niacin (consider reducing pitavastatin dose); caution. Potentiated by erythromycin, rifampin (see Adult dose). Monitor warfarin.
HMG-CoA reductase inhibitor.
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: cognitive impairment, fatal/non-fatal hepatic failure, immune-mediated necrotizing myopathy.