<p>Exposure to Elagolix early in pregnancy may increase the risk of early pregnancy loss. Use of Elagolix is contraindicated in pregnant women. Discontinue Elagolix if pregnancy occurs during treatment. The limited human data with the use of Elagolix in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage. Although two cases of congenital malformations were reported in clinical trials with Elagolix, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups. There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.<br />
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There are no adequate animal data on the excretion of Elagolix in milk. The developmental and health benefits of breastfeeding should be considered along with the mother&rsquo;s clinical need for Elagolix and any potential adverse effects on the breastfed child from Elagolix.</p>