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Eteplirsen Pregnancy and Breastfeeding Warnings

Brand names: Exondys 51

Medically reviewed by Last updated on Nov 6, 2023.

Eteplirsen Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk Summary: There are no human or animal data available on use of this drug to inform a drug-related risk.

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

Eteplirsen Breastfeeding Warnings

Benefit to mother should outweigh risk to the infant.

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

-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-Due to lack of safety data, this drug should be used during breastfeeding only if clearly needed.

See references

References for pregnancy information

  1. Product Information. Exondys 51 (eteplirsen). Sarepta Therapeutics. 2016.

References for breastfeeding information

  1. Product Information. Exondys 51 (eteplirsen). Sarepta Therapeutics. 2016.

Further information

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