Zolbetuximab Pregnancy and Breastfeeding Warnings

Brand names: Vyloy

Medically reviewed by Drugs.com. Last updated on Jan 7, 2025.

Zolbetuximab Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-This drug is used in combination with fluoropyrimidine- or platinum-containing chemotherapy. Refer to the prescribing information of fluoropyrimidine- and platinum-containing chemotherapy products for details on pregnancy testing, contraception, and infertility.

Animal studies have failed to reveal evidence of embryofetal toxicity. Placental transfer of this drug has been observed in pregnant mice. 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

Zolbetuximab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 8 months after the last dose.

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

Comments:
-The effects in the nursing infant or on milk production are unknown.
-Breastfeeding is not recommended since antibodies can excrete in human milk and cause adverse reactions in a nursing child.
-Potential adverse effects in the breastfed child due to this drug should be considered.

See references

Further information

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

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