Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There is a limited amount of data from the use of trientine in pregnant women.
Studies in animals have shown reproductive toxicity, which was probably a result of trientine-induced copper deficiency (see section 5.3).

Trientine should be used in pregnancy only after careful consideration of the benefits compared with the risks of discontinuing treatment in the individual patient. Factors to consider include the known risks associated with untreated or undertreated Wilson’s disease, risks associated with the stage of disease, the risk of those alternative treatments which are available and the possible effects of trientine (see section 5.3).

If treatment with trientine is to be continued following a risk-benefit analysis, consideration should be given to reducing the dose of trientine to the lowest effective dose and monitoring compliance with the treatment regimen.

The pregnancy should be closely monitored in order to detect possible foetal abnormality and to assess maternal serum copper levels throughout the pregnancy. The dose of trientine used should be adjusted in order to maintain serum copper levels within the normal range. Since copper is required for proper growth and mental development, dose adjustments may be required to ensure that the foetus will not become copper deficient and close monitoring of the patient is essential (see section 4.4)

Babies born to mothers being treated with trientine should be monitored for serum copper and ceruloplasmin levels where appropriate.

Breastfeeding
There is limited clinical data suggesting that trientine is not excreted in breast milk. However, a risk to the newborns/infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from trientine therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility
It is unknown whether trientine has an effect on human fertility.