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Ponesimod Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Jul 14, 2021.

Ponesimod is also known as: Ponvory

Ponesimod Pregnancy Warnings

When this drug was orally administered to animals throughout pregnancy at doses of up to 40 mg/kg, it showed an increased incidence of fetal malformations, decreased survival, reduced body weight gain, reduced fertility, and increases in a pre-and post-implantation loss at the highest dose tested, increased movement activity at the mid and high doses, and delayed sexual maturation at all doses tested. Maternal toxicity has not been observed, indicating a selective effect on the fetus. There are no adequate and well-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.

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: The receptor affected by this drug, sphingosine-1-phosphate receptor 1 has been demonstrated to have an important role in embryogenesis, including vascular and neural development; therefore, this drug may cause fetal harm when administered to a pregnant woman.

-This drug may harm a developing fetus.
-Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
-Females of reproductive potential should use effective contraception during treatment and for at least 1 week after the last dose.

See references

Ponesimod Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and any potential adverse effects on the breastfed infant.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

-No information is available on the effects on the breastfed infant, or the effects of the drug on milk production.

See references

References for pregnancy information

  1. "Product Information. Ponvory (ponesimod)." Janssen Pharmaceuticals, Titusville, NJ.

References for breastfeeding information

  1. "Product Information. Ponvory (ponesimod)." Janssen Pharmaceuticals, Titusville, NJ.

Further information

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