Lebrikizumab Pregnancy and Breastfeeding Warnings

Brand names: Ebglyss

Medically reviewed by Drugs.com. Last updated on Dec 19, 2024.

Lebrikizumab Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned

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

Comments:
-Transport of human IgG antibody across the placenta increases as pregnancy progresses; therefore, this drug may be transmitted from the mother to the developing fetus.
-Report pregnancies to Eli Lilly and Company at 1-800-545-5979.

Animal studies have failed to reveal evidence of fetal harm. In one animal study, no embryofetal toxicity or malformations, or effects on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age. There are no controlled data in human pregnancy; however, since human IgG is known to cross the placental barrier, this drug may be transmitted from the mother to the fetus.

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

Lebrikizumab Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Data Not Available

Comments:
-The effects in the nursing infant are unknown.
-Because this drug is a large protein molecule, the amount in milk is likely to be very low.
-Absorption by the infant is probably minimal as it is likely to be partially destroyed in the infant's gastrointestinal tract.
-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 to the breastfed infant from this or from the underlying maternal condition.

See references

Further information

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