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Nirsevimab Pregnancy and Breastfeeding Warnings

Brand names: Beyfortus

Medically reviewed by Drugs.com. Last updated on Aug 17, 2023.

Nirsevimab Pregnancy Warnings

This vaccine is not indicated for use in females of reproductive potential

US FDA pregnancy category: Not assigned

Risk summary: This vaccine is not approved for use in persons over 24 months of age.

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 healthcare 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

Nirsevimab Breastfeeding Warnings

This vaccine is not indicated for use in females of reproductive potential

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

Comments: This vaccine is not approved for use in persons over 24 months of age.

See references

References for pregnancy information

  1. (2023) "Product Information. Beyfortus (cvx 306) (nirsevimab (cvx 306))." sanofi pasteur

References for breastfeeding information

  1. (2023) "Product Information. Beyfortus (cvx 306) (nirsevimab (cvx 306))." sanofi pasteur

Further information

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