PrabotulinumtoxinA Pregnancy and Breastfeeding Warnings
Brand names: Jeuveau
Medically reviewed by Drugs.com. Last updated on Feb 8, 2024.
PrabotulinumtoxinA Pregnancy Warnings
Benefit should outweigh risk
US FDA pregnancy category: Not assigned
Risk Summary: There is insufficient information on use in pregnant women to inform a drug associated risk of adverse developmental outcomes; studies in pregnant rats have not shown maternal or embryofetal toxicities.
Intramuscular administration of doses up to 12 times the maximum recommended human dose (MRHD) once daily during organogenesis did not show maternal or embryofetal toxicities. There are no adequate and well-controlled studies in pregnant women.
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.
PrabotulinumtoxinA Breastfeeding Warnings
Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Unknown
Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.
See also
References for pregnancy information
- (2022) "Product Information. Jeuveau (prabotulinumtoxinA)." Evolus, Inc.
References for breastfeeding information
- (2022) "Product Information. Jeuveau (prabotulinumtoxinA)." Evolus, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
