Pregnancy: LIVALO is contraindicated during pregnancy (see Contraindications). Women of childbearing potential must take appropriate contraceptive precautions during treatment with LIVALO. Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the fetus, the potential risk for inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. Animal studies show evidence of reproductive toxicity, but no teratogenic potential (see Pharmacology: Toxicology: Preclinical safety data under Actions). If the patient is planning to become pregnant, treatment should be stopped at least one month prior to conception. If a patient becomes pregnant during use of LIVALO, treatment must be discontinued immediately.
Breastfeeding: LIVALO is contraindicated during breastfeeding (see Contraindications). Pitavastatin is excreted in rat milk. It is not known whether it is excreted in human milk.
Fertility: No current data.