Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

The recommended total daily ocular dose of cysteamine is no more than approximately 0.4% of the highest recommended dose of oral cysteamine in any age group. Systemic exposure of cysteamine following ocular administration is therefore lower than following oral administration. Although no effects during pregnancy and breast-feeding are anticipated, since systemic exposure to cysteamine is negligible, precautions should be taken with concomitant treatment with oral cysteamine.

Pregnancy
There are no adequate data from the use of cysteamine in pregnant women. Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3). The potential risk for humans is unknown. The effect on pregnancy of untreated cystinosis is also unknown.
Therefore, oral cysteamine should not be used during pregnancy, particularly during the first trimester, unless clearly necessary.
If a pregnancy is diagnosed or planned, the treatment should be carefully reconsidered and the patient must be advised of the possible teratogenic risk of cysteamine.

Breast-feeding
Cysteamine excretion in human's milk is unknown. However, due to the results of animal studies in breast-feeding mothers and neonates (see section 5.3), women taking oral cysteamine should not breast-feed.

Fertility
No data on the effect of cysteamine on human fertility are available. Studies in animals have shown a reduction on fertility (see section 5.3).