Evafact Use In Pregnancy & Lactation

Pregnancy: There is limited data from the use of dienogest in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Dienogest must not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Lactation: Treatment with dienogest during lactation is not recommended.
It is unknown whether dienogest is excreted in human milk. Data in animals have shown excretion of dienogest in rat milk.
A decision must be made whether to discontinue breast-feeding or to abstain from dienogest therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility: Based on the available data, ovulation is inhibited in the majority of patients during treatment with dienogest. However, dienogest is not a contraceptive.
If contraception is required a non-hormonal method should be used.
Based on available data, the menstrual cycle returns to normal within 2 months after cessation of treatment with dienogest.