Trofinetide Pregnancy and Breastfeeding Warnings
Brand names: Daybue
Medically reviewed by Drugs.com. Last updated on Sep 5, 2023.
Trofinetide Pregnancy Warnings
Safety has not been established in pregnant women.
US FDA pregnancy category: Not assigned.
Risk summary: Inadequate data available on use of this drug in pregnant women to inform a drug-related risk.
In animal studies, oral administration of this drug to pregnant animals did not result in any adverse effects on embryofetal, prenatal, or postnatal development. There are no controlled data in human pregnancy.
Last paragraphs:
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.
Trofinetide Breastfeeding Warnings
Benefit should outweigh risk.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
See also
References for pregnancy information
- (2023) "Product Information. Daybue (trofinetide)." Acadia Pharmaceuticals
References for breastfeeding information
- (2023) "Product Information. Daybue (trofinetide)." Acadia Pharmaceuticals
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
