Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in females
Women of childbearing potential should use effective contraception during treatment with POTELIGEO and for at least 6 months after treatment.

Pregnancy
There are no data from the use of mogamulizumab in pregnant women. Although mogamulizumab crosses the placental barrier in cynomolgus monkey, apart from the pharmacological effect in foetuses, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of mogamulizumab during pregnancy.

Breast-feeding
It is unknown whether mogamulizumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to the breast-fed child cannot be excluded during this short period. Afterwards POTELIGEO could be used during breast-feeding if clinically needed.

Fertility
There are no clinical data available on the effect of mogamulizumab on human fertility. No specific studies in animals have been performed to evaluate the effect of mogamulizumab on fertility. No adverse effects on male and female reproductive organs were observed in repeat-dose toxicity studies in cynomolgus monkeys (see section 5.3).