Etrasimod Pregnancy and Breastfeeding Warnings

Brand names: Velsipity

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

Etrasimod Pregnancy Warnings

According to some authorities: Use is contraindicated.

AU TGA pregnancy category: D
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:
-A pregnancy exposure registry is available.
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
-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 two weeks following the last dose.
-This drug should be discontinued at least 14 days before a pregnancy is planned.
-If a woman becomes pregnant during treatment, this drug should be discontinued immediately.

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.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Caution is recommended.
-According to some authorities: Use is contraindicated.

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.
-This drug is 98% bound to plasma proteins, which makes the amount in milk likely to be low. However, the risk to newborns/infants cannot be excluded.
-This drug should be used with caution, especially if 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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