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PrabotulinumtoxinA Pregnancy and Breastfeeding Warnings

PrabotulinumtoxinA is also known as: Jeuveau

Medically reviewed by Drugs.com. Last updated on Feb 18, 2020.

PrabotulinumtoxinA Pregnancy Warnings

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.

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.

See references

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 references

References for pregnancy information

  1. "Product Information. Jeuveau (prabotulinumtoxinA)." Evolus, Inc., Santa Barbara, CA.

References for breastfeeding information

  1. "Product Information. Jeuveau (prabotulinumtoxinA)." Evolus, Inc., Santa Barbara, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.