Fidanacogene elaparvovec Pregnancy and Breastfeeding Warnings

Brand names: Beqvez

Medically reviewed by Drugs.com. Last updated on Aug 20, 2024.

Fidanacogene elaparvovec Pregnancy Warnings

This product is not indicated for use in female patients.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this product in pregnant women to inform a drug-related risk.

Comments:
-No studies have been performed to assess the potential effect of this product on fertility in humans.
-Vector DNA was shed in semen but declined to undetectable levels within 1 to 4 months after infusion. Male patients should refrain from donating sperm and be abstinent or use condom for up to 6 months after receiving this product.

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

Fidanacogene elaparvovec Breastfeeding Warnings

This product is not indicated for use in female patients.

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

Comments:
-There is no information regarding this product on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-This product is not intended for administration in women.

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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