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Clascoterone topical Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Oct 20, 2021.

Clascoterone topical is also known as: Winlevi

Clascoterone topical Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk summary: There are no data on the developmental risk associated with use during human pregnancy; based on animal data, this drug may cause fetal harm.

Animal reproduction studies have revealed evidence of increased malformations and post-implantation loss and resorptions after subcutaneous administration at exposures greater than those used clinically. 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

Clascoterone topical Breastfeeding Warnings

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

-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. Winlevi (clascoterone topical)." Sun Pharmaceutical Industries (2021):

References for breastfeeding information

  1. "Product Information. Winlevi (clascoterone topical)." Sun Pharmaceutical Industries (2021):

Further information

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