Ella Use In Pregnancy & Lactation

Pregnancy: Ella is contraindicated during an existing or suspected pregnancy (see Contraindications).
Extremely limited data are available on the health of the foetus/newborn in case a pregnancy is exposed to ulipristal acetate. Although no teratogenic potential was observed, animal data are insufficient with regard to reproduction toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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 Marketing Authorisation Holder.
Breast-feeding: Ulipristal acetate is excreted in breast milk (see Pharmacology: Pharmacokinetics under Actions). The effect on newborn/infants has not been studied. A risk to the breastfed child cannot be excluded. After intake of Ella 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 Ella for emergency contraception; therefore regular contraception should be continued or initiated as soon as possible following use of Ella to ensure ongoing prevention of pregnancy. Advice on how to proceed is presented in Precautions.