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.
HMG-CoA reductase inhibitor.
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.
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.