Tapinarof topical Pregnancy and Breastfeeding Warnings

Brand names: Vtama

Medically reviewed by Drugs.com. Last updated on Nov 9, 2023.

Tapinarof topical Pregnancy Warnings

Safety has not been established during pregnancy. Caution is recommended.

US FDA pregnancy category: Not assigned

Risk summary: No data available on topical use of tapinarof in pregnant women to assess a drug associated risk.

In preclinical studies, a subcutaneous administration of tapinarof to pregnant rats and rabbits did not show any teratogenicity or significant adverse effects at doses 268 and 16 times, respectively, the maximum recommended human dose (MRHD). 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.

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Tapinarof topical Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments: Animal studies reported presence of tapinarof in rat offspring following subcutaneous administration to pregnant female rats, there is a potential of transfer of tapinarof in human milk.

Tapinarof was quantifiable in rat offspring plasma samples on postnatal day 10 following a subcutaneous administration at a dose of 6 and 30 mg/kg/day to pregnant rats from gestation day 6 through lactation day 20.

See references

Further information

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