Epcoritamab Pregnancy and Breastfeeding Warnings
Brand names: Epkinly
Medically reviewed by Drugs.com. Last updated on Nov 17, 2023.
Epcoritamab Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
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 four months 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 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.
Epcoritamab 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 four months after the last dose. This is due to the presence of maternal immunoglobulin G (IgG) in human milk and the potential for drug absorption leading to serious adverse reactions in the breastfed child.
See also
References for pregnancy information
- (2023) "Product Information. Epkinly (epcoritamab)." Genmab US, Inc.
References for breastfeeding information
- (2023) "Product Information. Epkinly (epcoritamab)." Genmab US, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
