Delandistrogene moxeparvovec Pregnancy and Breastfeeding Warnings
Brand names: Elevidys
Medically reviewed by Drugs.com. Last updated on Dec 14, 2023.
Delandistrogene moxeparvovec Pregnancy Warnings
This drug is not intended for use in pregnant women.
US FDA pregnancy category: Not assigned
Risk summary: This drug is not intended for use in pregnant women.
There are no controlled data in animal studies or 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.
Delandistrogene moxeparvovec Breastfeeding Warnings
The manufacturer makes no recommendation regarding use during lactation. This drug is not intended for use in lactating women.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-There is no information on the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.
See also
References for pregnancy information
- (2023) "Product Information. Elevidys (10-10.4 kg) (delandistrogene moxeparvovec)." Sarepta Therapeutics
References for breastfeeding information
- (2023) "Product Information. Elevidys (10-10.4 kg) (delandistrogene moxeparvovec)." Sarepta Therapeutics
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
