Fezolinetant Pregnancy and Breastfeeding Warnings

Brand names: Veozah

Medically reviewed by Drugs.com. Last updated on Sep 13, 2023.

Fezolinetant Pregnancy Warnings

Safety has not been established during pregnancy
-According to some authorities: Use is contraindicated

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-It is recommended that perimenopausal women of childbearing potential use an effective non-hormonal contraceptive method.

Animal studies revealed evidence of embryofetal lethality at the highest doses tested (at least 128-times the exposure at the human therapeutic dose); teratogenicity was not observed. Delayed parturition and delayed male reproductive maturation occurred at doses significantly above the human therapeutic dose. Decreased fetal weights and skeletal variations were observed in the context of maternal toxicity. Placental transfer was demonstrated in rats. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

Fezolinetant Breastfeeding Warnings

According to some authorities: Use is not recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (at concentrations higher than in maternal plasma)

Comments:
-The effects of this drug on milk production or on the nursing infant are unknown; a risk to the child cannot be excluded.
-A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the developmental and health benefits of breastfeeding as well as the mother's clinical need for this drug.

See references

Further information

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