NIKP-Pitavastatin Use In Pregnancy & Lactation

Pregnancy Category: X (See Contraindications and also Fetal/Neonatal Morbidity and Mortality as follows).
Fetal/Neonatal Morbidity and Mortality: Serum cholesterol and triglyceride concentrations increase during normal pregnancy and cholesterol products are essential for fetal development; therefore, suppression of cholesterol biosynthesis by pitavastatin during pregnancy may cause fetal harm.
Lactation: Pitavastatin is distributed into milk in rats, it is not known whether pitavastatin is distributed into human milk. Because of the potential for serious adverse reactions from pitavastatin in nursing infants, the drug is contraindicated in nursing women. Women who require pitavastatin therapy should be advised not to breast-feed their infants or advised to discontinue pitavastatin.
Women of childbearing potential should use effective contraceptive method during pitavastatin therapy. If the patients become pregnant while taking the drug, pitavastatin should be discontinued and the patients apprised of the potential fetal hazard and the lack of known clinical benefit with continued use during pregnancy.