Glofitamab Pregnancy and Breastfeeding Warnings

Brand names: Columvi

Medically reviewed by Drugs.com. Last updated on Oct 23, 2023.

Glofitamab Pregnancy Warnings

Safety has not been established

US FDA pregnancy category: Not assigned

Risk summary: This drug may cause fetal harm when administered to a pregnant woman.

Comments:
-This drug causes immune activation and response which may compromise pregnancy maintenance. Also, human immunoglobulin G (IgG) is known to cross the placenta, therefore this drug can potentially be transmitted from the mother to the developing fetus.
-Verify pregnancy status in females of reproductive potential prior to initiating treatment.
-Effective contraception is required during treatment and for one month after the last dose.

No animal reproductive or developmental toxicity studies have been conducted. 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

Glofitamab 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 on the nursing infant or milk production are unknown.
-Breastfeeding is not recommended during treatment with this drug and for one month after the last dose. This is due to the presence of immunoglobulin G (IgG) in human milk and the potential for drug absorption leading to B-cell depletion.

See references

Further information

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