Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Rosetemib S.K is contraindicated during pregnancy and breast-feeding (see section 4.3). Women of childbearing potential should use appropriate contraceptive measures.

Pregnancy
No clinical data are available on the use of ezetimibe during pregnancy. Animal studies on the use of ezetimibe in monotherapy have shown no evidence of direct or indirect harmful effects on pregnancy, embryofoetal development, birth or postnatal development (see section 5.3).

Since cholesterol and other products of cholesterol biosynthesis are essential for the development of the foetus, the potential risk from inhibition of HMG-CoA reductase outweighs the advantage of treatment during pregnancy. Animal studies provide limited evidence of reproductive toxicity (see section 5.3). If a patient becomes pregnant during use of Rosetemib S.K, treatment should be discontinued immediately.

Breast-feeding
Studies on rats have shown that ezetimibe is secreted into breast milk. It is not known if ezetimibe is secreted into human breast milk.

Rosuvastatin is excreted in the milk of rats. There are no data with respect to excretion in milk in humans (see section 4.3).

Fertility
No clinical trial data are available on the effects of ezetimibe or rosuvastatin on human fertility.
Ezetimibe had no effects on the fertility of male or female rats, rosuvastatin at higher doses showed testicular toxicity in monkeys and dogs (see section 5.3).