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Pregnancy: Fenofibrate/Simvastatin (Cholib): As simvastatin is contraindicated during pregnancy (see hereafter), Fenofibrate/Simvastatin (Cholib) is contraindicated during pregnancy (see Contraindications).
Fenofibrate: There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have shown embryo-toxic effects at doses in the range of maternal toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Therefore, fenofibrate should only be used during pregnancy after a careful benefit/risk assessment.
Simvastatin: Simvastatin is contraindicated during pregnancy. Safety in pregnant women has not been established. Maternal treatment with simvastatin may reduce the fetal levels of mevalonate which is a precursor of cholesterol biosynthesis. For these reasons, simvastatin must not be used in women who are pregnant, trying to become pregnant or suspect they are pregnant. Treatment with simvastatin must be suspended for the duration of pregnancy or until it has been determined that the woman is not pregnant.
Breast-feeding: It is unknown whether fenofibrate, simvastatin and/or their metabolites are excreted in human milk. Therefore, Fenofibrate/Simvastatin (Cholib) is contraindicated during breast-feeding (see Contraindications).
Fertility: Reversible effects on fertility have been observed in animals (see Pharmacology: Toxicology: Preclinical safety data under Actions). There are no clinical data on fertility from the use of Fenofibrate/Simvastatin (Cholib).
