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Eteplirsen Pregnancy and Breastfeeding Warnings

Eteplirsen is also known as: Exondys 51

Medically reviewed on October 12, 2016

Eteplirsen Pregnancy Warnings

Safety has not been established during pregnancy.

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.

Comments:
-This drug has not been studied in female patients.

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

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Exondys 51 (eteplirsen)." Sarepta Therapeutics, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Exondys 51 (eteplirsen)." Sarepta Therapeutics, Cambridge, MA.

Further information

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

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