Leqembi Pregnancy Warnings
Animal studies have not been reported. 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.
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned
Risk summary:
Inadequate data available on use of this drug in pregnant women to inform a drug-related risk.
See references
Leqembi Breastfeeding Warnings
The manufacturer makes no recommendation regarding use during lactation.
Excreted into human milk: Data not available
Excreted into animal milk: Unknown
Comments:
-Based on literature from other monoclonal antibodies (mAbs), the extent of transfer of mAbs to human milk is low, and limited systemic exposure to the breastfed infant is reported.
-The effects in the nursing infant are unknown.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.
See references
