Nexlizet Use In Pregnancy & Lactation

Pregnancy: Nexlizet is contraindicated during pregnancy (see Contraindications).
There are no or limited amount of data from the use of Nexlizet 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, Nexlizet may cause foetal harm when administered to pregnant women. Nexlizet 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).
Contraception: Women of childbearing potential must use effective contraception during treatment. Patients should be advised to stop taking Nexlizet before stopping contraceptive measures if they plan to become pregnant.
Breast-feeding: It is unknown whether bempedoic acid/metabolites or ezetimibe/metabolites are excreted in human milk. Because of the potential for serious adverse reactions, women taking Nexlizet should not breast-feed their infants. Nexlizet is contraindicated during breast-feeding (see Contraindications).
Fertility: No data on the effect of Nexlizet on human fertility are available. Based on animal studies, no effect on reproduction or fertility is expected with Nexlizet (see Pharmacology: Toxicology: Preclinical safety data under Actions).