Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Pregnancy
Ella is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant (see section 4.2).

Ulipristal acetate does not interrupt an existing pregnancy.

Pregnancy may occasionally occur after ulipristal acetate intake. Although no teratogenic potential has been observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
Limited human data regarding pregnancy exposure to Ella do not suggest any safety concern.
Nevertheless it is important that any pregnancy in a woman who has taken Ella be reported.
HRA Pharma maintains a pregnancy registry to monitor outcomes of pregnancy in women exposed to Ella. Patients and health care providers are encouraged to report any exposure to Ella by contacting the License Holder/Importer or the Manufacturer (see section 7 and 8). All patient data collected will remain anonymous.

Breast-feeding

Ulipristal acetate is excreted in breast milk (see section 5.2). The effect on newborn/infants has not been studied. A risk to the breastfed child cannot be excluded. After intake of ulipristal acetate for emergency contraception, breastfeeding is not recommended for one week. During this time it is recommended to express and discard the breast milk in order to stimulate lactation.


Fertility
A rapid return of fertility is likely following treatment with ulipristal acetate for emergency contraception. Women should be advised to use a reliable barrier method for all subsequent acts of intercourse until the next menstrual period.