Nadofaragene firadenovec Pregnancy and Breastfeeding Warnings

Brand names: Adstiladrin

Medically reviewed by Drugs.com. Last updated on Dec 5, 2023.

Nadofaragene firadenovec 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:
-Inform pregnant women of the potential risk to a fetus.
-Verify pregnancy status in females of reproductive potential before initiating this treatment.
-Advise females of reproductive potential to use effective contraception during treatment with this drug and for 6 months after the last dose.
-Advise male patients with female partners of reproductive potential to use effective contraception during this treatment and for 3 months after the last dose.

No animal studies have been conducted to study reproductive and developmental toxicity with this drug. 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.

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Nadofaragene firadenovec Breastfeeding Warnings

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 on the breastfed infant.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-No information available regarding the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production.

See references

Further information

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

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