Tremelimumab Pregnancy and Breastfeeding Warnings

Brand names: Imjudo

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Tremelimumab Pregnancy Warnings

Safety has not been established 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.

Comments:
-Based on findings from animal studies and its mechanism of action, 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 has the potential to be transferred from the mother to the developing fetus.
-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.

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.

See references

Tremelimumab Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 3 months after the last dose.

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

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-The effects of local gastrointestinal (GI) 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.

As this drug is a large protein molecule with a molecular weight of 149,000 Da, the amount in milk is likely to be very low.

See references

Further information

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