Sensitivity Reaction: Hypersensitivity reactions, including rash, pruritus, and urticaria have been reported with pitavastatin.
Fetal/Neonatal Morbidity and Mortality: Cholesterol and related compounds are vital for fetal development. Thus, inhibition of cholesterol synthesis is harmful for fetus. Women of child bearing potential should be prevented from pregnancy, by using effective method of contraception, during pitavastatin therapy.
Hepatic Effects: Increased serum aminotransferase concentrations have been reported in patients receiving pitavastatin. These increases usually were mild, transient and resolved or improved with continued or temporary discontinued therapy. Liver function tests should be performed prior to starting of pitavastatin therapy and periodically thereafter, particularly at any increases in pitavastatin dosage. If increases in AST or ALT concentrations exceeding 3 times of the upper limit of normal ranges, dosage of pitavastatin should be reduced or discontinued until the abnormality was resolved. Alcoholic patients should use pitavastatin with special caution and this drug is contraindicated in patients with patients with active liver disease, including unexplained, persistent elevations in serum aminotransferase concentrations.
Musculoskeletal Effects: There are some reports of myopathy and rhabdomyolysis in patients receiving statins including pitavastatin. These effects can occur at any dosage of statins, but risk increase at higher dose. Predisposing factors of these effects are advanced age, renal impairment, hypothyroidism, and concomitant use of particular antilipemic agents (i.e., fibric acid derivatives and niacin). Patients receiving pitavastatin should be monitored periodically. Pitavastatin therapy should be discontinued if serum creatine kinase (creatine phosphokinase [CK, CPK]) levels markedly increase or myopathy is identified.
Renal Impairment: Dosage adjustments are recommended for patients with creatinine clearance less than 60 mL/min or in patients with end-stage renal disease who are undergoing hemodialysis. Pitavastatin should not be used in severe renal patients (GFR less than 30 mL/min) who are not undergoing hemodialysis. (See Dosage & Administration).