Garadacimab Pregnancy and Breastfeeding Warnings

Brand names: Andembry

Medically reviewed by Drugs.com. Last updated on Jul 22, 2025.

Garadacimab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

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

Comments:
-Monoclonal antibodies (including this drug) are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during this period.

Animal studies have failed to reveal evidence of fetal harm. Administration of this drug to pregnant animals at maternal doses about 100 times the exposure at the maximum recommended human dose did not demonstrate embryofetal or maternal toxicity. This drug crosses the placenta and fetal plasma concentrations were 40.8% of maternal concentrations after IV or subcutaneous dosing. 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

Garadacimab Breastfeeding Warnings

Safety has not been established.

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

Comments:
-The effects of this drug in the nursing infant or on milk production are unknown.
-The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant are unknown.
-This drug is a humanized immunoglobulin G (IgG) antibody; maternal IgG antibodies are known to be present in human milk.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug, as well as any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

Further information

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

Medical Disclaimer