Use in Pregnancy: Pitavastatin is contraindicated for use in pregnant women since safety in pregnant women has not been established and there is no apparent benefit to therapy with Pitavastatin during pregnancy. Because HMG-CoA reductase inhibitors decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, Pitavastatin may cause fetal harm when administered to pregnant women. Pitavastatin should be discontinued as soon as pregnancy is recognized.
Use in Lactation: Risk Summary: Pitavastatin is contraindicated during breastfeeding. There is no available information on the effects of the drug on the breastfed infant or the effects of the drug on milk production. However, it has been shown that another drug in this class passes into human milk. Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with Pitavastatin.
Females and Males of Reproductive Potential: Contraception: Females: Pitavastatin may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with Pitavastatin.