Revakinagene taroretcel Pregnancy and Breastfeeding Warnings

Brand names: Encelto

Medically reviewed by Drugs.com. Last updated on Jun 23, 2025.

Revakinagene taroretcel Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

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

Animal studies have failed to reveal evidence of teratogenicity. Subcutaneous administration to pregnant rats and rabbits demonstrated no evidence of teratogenic effects. However, administration of this drug to rabbits at 10 micrograms/kg/day dose resulted in decrease in implantations and live fetuses. In rats administered doses of 100 mcg/kg/day, a decrease in the corpora lutea was observed.

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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Revakinagene taroretcel Breastfeeding Warnings

Safety has not been established.

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

Comments:
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-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 adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

Further information

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