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Prademagene zamikeracel topical Pregnancy and Breastfeeding Warnings

Brand names: Zevaskyn

Medically reviewed by Drugs.com. Last updated on Jul 22, 2025.

Prademagene zamikeracel topical 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.

Comment:
-Use of adequate methods of contraception should be encouraged.

Animal studies have not been reported. 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

Prademagene zamikeracel topical Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

See references

Does Prademagene zamikeracel topical interact with my other drugs?

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References for pregnancy information

  1. (2025) "Product Information. Zevaskyn (prademagene zamikeracel topical)." Abeona Therapeutics Inc.

References for breastfeeding information

  1. (2025) "Product Information. Zevaskyn (prademagene zamikeracel topical)." Abeona Therapeutics Inc.

Further information

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