Datopotamab deruxtecan Pregnancy and Breastfeeding Warnings

Brand names: Datroway

Medically reviewed by Drugs.com. Last updated on Feb 18, 2025.

Datopotamab deruxtecan Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on its mechanism of action, this drug can cause embryofetal harm when administered during pregnancy; no data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-The topoisomerase inhibitor component of this drug, DXd, is genotoxic and affects actively dividing cells.
-Patients should be apprised of the potential harm to the fetus.
-Before starting this drug, pregnancy status of patients of childbearing potential should be verified.
-Patients of childbearing potential should be advised to use effective contraception during therapy and for 7 months after the last dose.
-Due to the potential for genotoxicity, male patients with partners of childbearing potential should be advised to use effective contraception during therapy and for 4 months after the last dose.

Animal studies on developmental toxicity have not been reported. Based on toxicity studies in animals, this drug may impair male and female reproductive function and fertility; the effects on animal reproductive organs were irreversible. 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

Datopotamab deruxtecan Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 month after the last dose.

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

Comments:
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions in a breastfed child.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer