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Golodirsen Pregnancy and Breastfeeding Warnings

Golodirsen is also known as: Vyondys 53

Medically reviewed by Drugs.com. Last updated on Feb 18, 2020.

Golodirsen Pregnancy Warnings

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.

Safety has not been established during pregnancy

US FDA pregnancy category: Not assigned

Risk Summary: There are no human or animal data available to assess use during pregnancy.

See references

Golodirsen Breastfeeding Warnings

Benefit should outweigh risk

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Vyondys 53 (golodirsen)." Sarepta Therapeutics, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Vyondys 53 (golodirsen)." Sarepta Therapeutics, Cambridge, MA.

Further information

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