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Use in Pregnancy: There are 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 under Actions). However, Visanne should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
Use in Lactation: Treatment with Visanne during lactation is not recommended. Physiochemical properties and animal data indicate excretion of dienogest in breast milk. A decision must be made whether to discontinue breastfeeding or to abstain from Visanne therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
