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Pregnancy: Nilemdo 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, Nilemdo may cause foetal harm when administered to pregnant women. Nilemdo should be discontinued prior to conception or as soon as pregnancy is planned or 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 Nilemdo should not breast-feed their infants. Nilemdo is contraindicated during breast-feeding (see Contraindications).
Fertility: No data on the effect of Nilemdo on human fertility are available. Based on animal studies, no effect on reproduction or fertility is expected with Nilemdo (see Pharmacology: Toxicology: Preclinical safety data under Actions).
