Nexletol Use In Pregnancy & Lactation

Pregnancy: Nexletol is contraindicated during pregnancy (see Contraindications).
There are no or limited amount of data from the use of bempedoic acid in pregnant women. Studies in animals with bempedoic acid have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Because bempedoic acid decreases cholesterol synthesis and possibly the synthesis of other cholesterol derivatives needed for normal foetal development, Nexletol may cause foetal harm when administered to pregnant women. Nexletol should be discontinued prior to conception or as soon as pregnancy is recognized (see Contraindications).
Women of childbearing potential: Women of childbearing potential should use effective contraception during treatment (see Precautions).
Breast-feeding: It is unknown whether bempedoic acid/metabolites are excreted in human milk. Because of the potential for serious adverse reactions, women taking Nexletol should not breast-feed their infants. Nexletol is contraindicated during breast-feeding (see Contraindications).
Fertility: No data on the effect of Nexletol on human fertility are available. Based on animal studies, no effect on reproduction or fertility is expected with Nexletol (see Pharmacology: Toxicology: Preclinical safety data under Actions).