Lecanemab Pregnancy and Breastfeeding Warnings

Brand names: Leqembi

Medically reviewed by Drugs.com. Last updated on Jul 10, 2023.

Lecanemab Pregnancy Warnings

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.

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.

See references

Lecanemab 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

Further information

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