Antidote (Monoclonal Antibody)
PREGNANCY RECOMMENDATION:No Human Data and No Relevant Animal Data
BREASTFEEDING RECOMMENDATION:Probably Compatible
No reports describing the use of idarucizumab in human pregnancy have been located. As a Fab-only portion of an immunoglobulin G (IgG) antibody, the drug will not likely cross the placenta, so fetal exposure should be negligible. However, the absence of human pregnancy experience prevents a complete assessment of the embryofetal risk. Animal reproduction studies have not been performed. Using this drug during pregnancy should be based on the pros and cons of the mother’s clinical need for treatment versus any potential fetal risk that might occur from exposure.
No reports describing the use of idarucizumab during human lactation have been located. Limited amounts of the drug may be excreted into breast milk. However, it is known that IgG antibodies can be found in human breast milk but are not found in the neonatal or infant circulation. Additionally, if any IgG antibodies were to be ingested through breastfeeding, they would probably be digested in the infant’s gastrointestinal tract and not be absorbed. Breastfeeding while using this drug should be based on the mother's clinical need for treatment. If used while breastfeeding, the infant should be monitored for the most common reported adult side effects of nausea and headache (both leading to irritability) and constipation.