Imjudo Pregnancy Warnings
In animal studies, an increased risk of immune-mediated rejection of the developing fetus and fetal death have been reported with the use of this drug. There are no controlled data in human pregnancy.
This drug blocks cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is responsible for maintaining maternal immune tolerance in the fetus to preserve pregnancy and in the immune regulation of the newborn. In animal models, CTLA-4 blockade resulted in increased resorptions and fetal death.
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.
The manufacturer makes no recommendation regarding use 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.
-This drug has the potential to harm a developing fetus when administered to a pregnant woman.
-Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, this drug is likely to be transferred from the mother to the developing fetus.
Comments:
-Verify pregnancy status in females of childbearing potential prior to initiating treatment with this drug.
-Pregnant women and females of reproductive potential should be apprised of the potential harm to the fetus.
-Adequate methods of contraception should be encouraged during treatment with this drug and for 3 months after the last dose.
See references
Imjudo Breastfeeding Warnings
Breastfeeding is not recommended during use of this drug.
Excreted into human milk: Data not available
Excreted into animal milk: Data not available
Comments:
-The effects of local gastrointestinal exposure and limited systemic exposure on the breastfed child are unknown.
-Maternal immunoglobulin is known to be secreted into human milk.
-This drug has the potential to cause serious adverse reactions in a breastfed child; therefore, breastfeeding is not recommended during treatment with this drug and for 3 months after the last dose.
See references
