Elranatamab Pregnancy and Breastfeeding Warnings

Brand names: Elrexfio

Medically reviewed by Drugs.com. Last updated on Jan 8, 2024.

Elranatamab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

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

Comments:
-This drug can harm a developing fetus based on the mechanism of action.
-Immune activation may compromise the maintenance of pregnancy when using this drug, as it induces T-cell activation and cytokine release.
-This drug can cause B-cell lymphocytopenia in infants exposed to it in utero.
-This drug may be transmitted from the mother to the developing fetus, as human immunoglobulin (IgG) is known to cross the placenta.
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Women of childbearing potential should be encouraged to use adequate methods of contraception during treatment and for 4 months after the last dose.
-Consider assessing immunoglobulin levels in newborns of mothers treated with this drug as it is associated with hypogammaglobulinemia.

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 healthcare 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

Elranatamab Breastfeeding Warnings

Breastfeeding is not recommended during the use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant or on milk production are unknown.

Level 2:
Although maternal IgG is known to be present in human milk, there is no data on the presence of this drug. Breastfeeding is not recommended during treatment and for 4 months after the last dose due to potential adverse effects in breastfed infants.

See references

Further information

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