Sign Out
Pregnancy: Nustendi is contraindicated during pregnancy (see Contraindications).
There are no or limited amount of data from the use of Nustendi 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, Nustendi may cause foetal harm when administered to pregnant women. Nustendi 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 or ezetimibe/metabolites are excreted in human milk. Because of the potential for serious adverse reactions, women taking Nustendi should not breastfeed their infants. Nustendi is contraindicated during breast-feeding (see Contraindications).
Fertility: No data on the effect of Nustendi on human fertility are available. Based on animal studies, no effect on reproduction or fertility is expected with Nustendi (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Continue with Google