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Sacituzumab govitecan Pregnancy and Breastfeeding Warnings

Sacituzumab govitecan is also known as: Trodelvy

Medically reviewed by Drugs.com. Last updated on Aug 10, 2020.

Sacituzumab govitecan Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action, this drug can cause teratogenicity and/or embryofetal lethality when administered to a pregnant woman. It contains a genotoxic component, SN-38, and is toxic to rapidly dividing cells.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for 6 months after.
-Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 3 months after.
-This drug may impair fertility in females of reproductive potential.

There were no reproductive and developmental toxicology studies conducted in animals. 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

Sacituzumab govitecan Breastfeeding Warnings

Use should be avoided.

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

Comments:
-The effects in the nursing infant are unknown.
-Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during therapy and for 1 month after.

See references

References for pregnancy information

  1. "Product Information. Trodelvy (sacituzumab govitecan)." Immunomedics, Morris Plains, NJ.

References for breastfeeding information

  1. "Product Information. Trodelvy (sacituzumab govitecan)." Immunomedics, Morris Plains, NJ.

Further information

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