Ponesimod Pregnancy and Breastfeeding Warnings

Brand names: Ponvory

Medically reviewed by Drugs.com. Last updated on Jul 4, 2023.

Ponesimod Pregnancy Warnings

-Safety has not been established during pregnancy.
-According to some authorities, use is contraindicated in women of childbearing potential not using effective contraception, and during pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on the mechanism of action and findings in animals, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-This drug may harm a developing fetus.
-Post-marketing data and clinical experience from patients taking another sphingosine 1-phosphate (S1P) receptor modulator suggest that this drug is associated with an increased risk of major congenital malformations.
-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.
-If a woman becomes pregnant during treatment, this drug must be immediately discontinued.

When this drug was orally administered to animals throughout pregnancy and lactation, the offspring 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.

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

Ponesimod Breastfeeding Warnings

Benefit should outweigh risk. According to some authorities, breastfeeding is not recommended during use of this drug.

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

Comments:
-No information is available on the effects on the breastfed infant, or the effects of the drug on milk production.
-This drug is highly bound in maternal plasma and is unlikely to reach breastmilk in large quantities; however, it is potentially toxic to the breastfed infant.
-In animal studies, administration of this drug at all doses (including below the recommended human dose) during pregnancy and lactation resulted in adverse effects in offspring.

See references

Further information

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