Pozelimab Pregnancy and Breastfeeding Warnings

Brand names: Veopoz

Medically reviewed by Drugs.com. Last updated on Dec 19, 2023.

Pozelimab 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:
-Monoclonal antibodies can be actively transported across the placenta. Therefore, this drug has the potential to be transmitted from the mother to the developing fetus.

Animal studies have failed to reveal evidence of embryofetal toxicity. 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

Pozelimab Breastfeeding Warnings

Benefit should outweigh the risk.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-The effects in the nursing infant or on milk production are unknown.
-Considering the fact that endogenous maternal IgG and monoclonal antibodies are transferred into human milk, this drug has the potential to be excreted in human milk.
-A risk to the breast-fed child cannot be excluded.

See references

Further information

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