Etranacogene dezaparvovec Pregnancy and Breastfeeding Warnings

Brand names: Hemgenix

Medically reviewed by Drugs.com. Last updated on Nov 2, 2023.

Etranacogene dezaparvovec Pregnancy Warnings

This drug is not indicated for use in female patients.

Country specific risk category
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.

No adverse effects on mating rate and fertility indices or fetal weights were observed in healthy naive female mice mated with healthy male mice that were intravenously administered a predecessor of this drug product 6 days prior to mating. No evidence of presence of vector DNA in the uterus, placenta, or fetus was 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.

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