Skip to main content

Pafolacianine Pregnancy and Breastfeeding Warnings

Pafolacianine is also known as: Cytalux

Pafolacianine Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: There are no available data to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on its mechanism of action, this drug may cause fetal harm when administered to a pregnant woman.

-A pregnancy test should be obtained prior to administration of this drug.
-Females of reproductive potential should be informed of potential risk to a fetus with use of this drug.

Animal data has not shown significant drug-related embryofetal toxicity. However, based on this drug's mechanism of action, there is a potential for fetal harm when administered during pregnancy. 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

Pafolacianine Breastfeeding Warnings

Benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

-There are no data on the effects on the breastfed infant, or the effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Cytalux (pafolacianine)." Grand River Aseptic Manufacturing (2021):

References for breastfeeding information

  1. "Product Information. Cytalux (pafolacianine)." Grand River Aseptic Manufacturing (2021):

Further information

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