Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential
Women of childbearing potential should use an effective method of contraception. The use of oral contraceptives is not recommended in patients taking Chenodeoxycholic acid Leadiant, see section 4.5 for further details.

Pregnancy
Patients with CTX and high cholestanol have been shown to have adverse outcomes during pregnancy.
Two intrauterine deaths in a mother with CTX have been reported in the literature. Two pregnancies in mothers with CTX resulted in premature infants with evidence of intrauterine growth retardation also reported in the literature. There are no or limited amount of data from the use of Chenodeoxycholic acid Leadiant in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3).
Chenodeoxycholic acid Leadiant is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding
It is unknown whether chenodeoxycholic acid/metabolites are excreted in human milk.

A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Chenodeoxycholic acid Leadiant therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman

Fertility
Chenodeoxycholic acid is an endogenous bile acid used for replacement therapy and it is anticipated to have no effects on fertility at therapeutic doses.