Dienosis Use In Pregnancy & Lactation

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 also Pharmacology: Toxicology: Preclinical safety data under Actions). However, Dienogest 2 mg tablets should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
The increased risk of VTE during the postpartum period should be considered when re-starting dienogest 2 mg tablets (see Precautions).
Lactation: Treatment with Dienogest 2 mg tablets 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 breast-feeding or to abstain from Dienogest 2 mg tablets therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Based on available data, ovulation is inhibited in the majority of patients during treatment with Dienogest 2 mg tablets. However, Dienogest 2 mg tablets is not a contraceptive.
Dienogest 2 mg tablets was not studied for contraceptive efficacy, but DNG 2 mg has been shown in a study involving 20 women to inhibit ovulation after 1 month of treatment. 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 Dienogest 2 mg tablets.