Etrasimod Pregnancy and Breastfeeding Warnings

Brand names: Velsipity

Medically reviewed by Drugs.com. Last updated on Dec 19, 2023.

Etrasimod Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not Assigned

Risk Summary: Based on findings from animal studies, this drug may cause fetal harm when administered to a pregnant woman.

Comments:
-There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to this drug during pregnancy. Pregnant females and healthcare providers can contact the registry by calling 1-800-616-3791.
-Before treatment initiation, females of reproductive potential should be counseled on the potential risks to the fetus and the need for effective contraception during treatment and for one week following the last dose.

Animal reproduction studies showed that administration of this drug during organogenesis produced adverse effects on development, including embryolethality and fetal malformations, in both rats and rabbits at maternal exposures 5 and 6 times, respectively, the maximum recommended human dose (MRHD). Reduced maternal fertility and reproductive performance including reduction in implantations and increased preimplantation loss of offspring occurred at the highest dose tested (maternal exposure 24 times the MRHD). No adverse effects were found on fertility of male rats at exposures up to 467 times the MRHD. 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.

See references

Etrasimod Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

See references

Further information

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