Endovelle Use In Pregnancy & Lactation

Pregnancy: There is limited data from the use of dienogest in pregnant women. Animal studies and data from women exposed to dienogest during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans (see Pharmacology: Toxicology: Preclinical safety data under Actions). However, ENDOVELLE should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Lactation: ENDOVELLE should not be used during lactation. Physiochemical properties and animal data indicate excretion of dienogest in breast milk. A decision must be made whether to discontinue breast-feeding or to abstain from ENDOVELLE therapy taking into account the benefit of breast-feeding for the child and benefit of therapy for the woman.
Fertility: Based on the available data, ovulation is inhibited in the majority of patients during treatment with ENDOVELLE. However, ENDOVELLE is not a contraceptive.
If contraception is required a non-hormonal method should be used (See Precautions).
Based on available data, the menstrual cycle returns to normal within 2 months after cessation of treatment with ENDOVELLE.