Efinaconazole topical Pregnancy and Breastfeeding Warnings

Brand names: Jublia

Medically reviewed by Drugs.com. Last updated on May 20, 2024.

Efinaconazole topical Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of embryofetal toxicity at subcutaneous doses that produced maternal toxicity; animal studies have failed to reveal evidence of malformations or embryofetal toxicity in pregnant rats and rabbits at subcutaneous doses up to 112 and 154 times, respectively, the maximum recommended human dose based on AUC comparison. 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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Efinaconazole topical Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Yes (after subcutaneous doses)

Comments:
-This drug has not been studied during breastfeeding.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug should be considered.
-Maternal blood levels are very low after topical application to toenails; it is unlikely a measurable amount of drug will enter breast milk.

See references

Further information

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