Elagolix Pregnancy and Breastfeeding Warnings

Brand names: Orilissa

Elagolix Pregnancy Warnings

Contraindicated

US FDA pregnancy category: Not Assigned

Risk Summary: Exposure to this drug early in pregnancy may increase the risk of early pregnancy loss; limited human data are insufficient to determine if there is a risk for major birth defects or miscarriage.

Comments:
-Pregnancy must be excluded before starting therapy or therapy must start within 7 days from onset of menses.
-Pregnancy testing should be performed if pregnancy is suspected, and discontinued if pregnancy is confirmed.
-Advise women to use effective non-hormonal contraception during therapy and for 28 days following discontinuation
-Coadministration with combined hormonal contraceptives may lead to increased risk of adverse events including thromboembolic disorder and vascular events and is not recommended.
-A pregnancy registry is available.

Pregnant rats and rabbits receiving this drug during the period of organogenesis experienced post implantation loses at 20 times the maximum recommended human dose (MRHD). In rabbits, spontaneous abortion and total litter loss occurred at 7 and 12 times the MRHD. Structural abnormalities were not reported at doses up to 40 (rat) and 12 (rabbit) times the MRHD. In human clinical trials, 49 pregnancies were reported; these pregnancies occurred during therapy or within 30 days of stopping. Two cases of congenital malformation were reported; one case of infant cleft palate (exposure occurred during the first 30 days of pregnancy) and 1 case of infant tracheoesophageal fistula (exposure occurred during the first 15 days of pregnancy). In both cases, the dose was 150 mg/day. Five cases of spontaneous abortion occurred in those receiving this drug compared to 5 cases among 20 pregnancies in women (n=1100) receiving placebo. There are no controlled data in human pregnancy.

Pregnancy Registry: There is a pregnancy registry that monitors outcomes in women who become pregnant during therapy; pregnant patients should be encouraged to enroll by calling 1-833-782-7241.

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.

See references

Elagolix Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-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.

This drug is a peptide that is likely digested in the infant's gastrointestinal tract, so it is unlikely to reach clinically important levels in infant serum. It has a half-life of 4 to 6 hours. Because there is no information available on its use during breastfeeding, caution should be used, especially while nursing a newborn or preterm infant.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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