Contraindicated

US FDA pregnancy category: Not assigned

Risk Summary: Exposure to this combination drug early in pregnancy may increase the risk of early pregnancy loss; discontinue therapy if pregnancy occurs.

Comments:
-Rule out pregnancy prior to initiating therapy or initiate therapy within 7 days from the onset of menses.
-Non-hormonal contraception is recommended during treatment and for 28 days after discontinuation.
-Due to change in menstrual bleeding pattern during therapy, recognition of pregnancy may be reduced; perform pregnancy testing if pregnancy is suspected and discontinue therapy if pregnancy is confirmed.
-A pregnancy registry is available; pregnant patients should be encouraged to enroll by calling 1-833-782-7241.

Pregnant rats and rabbits receiving elagolix at 12 times the maximum recommended human dose (MRHD) during the period of organogenesis experienced post implantation loss. In rabbits, spontaneous abortion was observed at 4 times the MRHD and total litter loss was observed at 7 times the MRHD. Human data is insufficient to determine whether there is a risk for major birth defects or miscarriage with elagolix use. During phase 3 trials with this combination drug, a single pregnancy was reported. This pregnancy resulted in a spontaneous abortion; the estimated fetal exposure occurred during the first 18 days of pregnancy. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Women who are breastfeeding while taking estrogen have been shown to have a decrease in quantity and quality of their breast milk. This reduction can occur at any time but is less likely to occur once breast-feeding is well established. In women taking combination estrogen and progestin, detectable amounts of estrogen and progestin have been found in breast milk. There is no information on the excretion of elagolix into human or animal milk.

Benefit should outweigh risk

Excreted into human milk: elagolix (unknown); estrogen and progestins (yes)
Excreted into animal milk: elagolix (unknown)

Comments:
-Breastfeeding women should be advised to use non-hormonal contraception.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references