Fezolinetant Pregnancy and Breastfeeding Warnings

Brand names: Veozah

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

Fezolinetant Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There are no data available on the use of this drug in pregnant patients to inform a drug-associated risk.

Comments:
-This drug is not indicated for use in women of childbearing potential.

In animal studies, evidence of embryo-fetal lethality, delayed parturition, and delayed male reproductive maturation occurred at doses significantly above the human therapeutic dose. Teratogenicity was not observed. 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

Fezolinetant Breastfeeding Warnings

There are no data to inform a drug-associated risk in breastfeeding patients.

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

Comments:
-This drug is not indicated for use in women with potential for lactation.

See references

Further information

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