Linvoseltamab Pregnancy and Breastfeeding Warnings

Brand names: Lynozyfic

Medically reviewed by Drugs.com. Last updated on Aug 5, 2025.

Linvoseltamab Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
-Advise women of childbearing potential to use effective contraception during therapy and for 3 months after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Consider assessing immunoglobulin levels in newborns of mothers treated with this drug due to the risk of hypogammaglobulinemia.
-Human immunoglobulin G is known to cross the placenta after the first trimester; therefore, this drug may be transmitted from the mother to the developing fetus.
-This drug causes immune activation (T-cell activation and cytokine release) which may compromise pregnancy maintenance and potentially cause B-cell lymphocytopenia in infants exposed in-utero.

Animal studies have not been reported; however, based on its mechanism of action, this drug can cause fetal harm. 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.

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Linvoseltamab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 3 months after the last dose.

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

Comments:
-The effects in the nursing infant are unknown; there is a potential for serious adverse reactions.
-There are no data on the presence of this drug in human milk or the effects of this drug on milk production.
-This drug is a human immunoglobulin G (IgG) antibody; maternal IgG antibodies are known to be present in human milk.

See references

Further information

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