Inebilizumab Pregnancy and Breastfeeding Warnings

Brand names: Uplizna

Medically reviewed by Drugs.com. Last updated on Jul 18, 2023.

Inebilizumab Pregnancy Warnings

Safety during pregnancy is unknown

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data on the use of this drug in pregnant women; based on animal data, this drug can cause fetal harm due to B-cell lymphopenia and reduces antibody response in offspring exposed to this drug even after B-cell repletion.

Comments:
-Women of childbearing potential should use adequate contraception during therapy and for 6 months after the last dose.

Animal studies indicate that this drug crosses the placenta and can deplete fetal B cells. 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

Inebilizumab Breastfeeding Warnings

Safety has not been established.

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

Comments:
-IgG is excreted into human milk, so it is expected that this drug will be present in human milk; however, antibodies in human milk do not enter the neonatal and infant circulation in substantial amounts.
-Some experts say breastfeeding should be discontinued during therapy and up to 6 months after.

Because many drugs including antibodies are present in human milk, lactating women should be advised not to breastfeed during treatment and for at least 6 months after the last dose due to the potential for serious adverse reactions in breastfed infants.

See references

Further information

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