Valoctocogene roxaparvovec Pregnancy and Breastfeeding Warnings

Brand names: Roctavian

Medically reviewed by Drugs.com. Last updated on Apr 8, 2024.

Valoctocogene roxaparvovec Pregnancy Warnings

This drug is not indicated for use in women.

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:
-Use of effective methods of contraception should be encouraged for 6 months after administering this drug.
-Advice men not to donate semen for 6 months after taking this drug.

Animal studies have not been reported. There are no controlled data in human pregnancy.

Animal reproduction and developmental toxicity studies have not been conducted. In nonclinical studies, vector DNA was detected in the testes of healthy mice for at least 182 days after administering this drug. In clinical studies, after administration of this drug, transgene DNA was detectable in semen.

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

Valoctocogene roxaparvovec Breastfeeding Warnings

This drug is not indicated for use in women.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant are unknown.

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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