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Avelumab Pregnancy and Breastfeeding Warnings

Avelumab is also known as: Bavencio

Medically reviewed by Last updated on May 29, 2019.

Avelumab Pregnancy Warnings

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Human IgG1 immunoglobulins (IgG1) are known to cross the placenta; therefore, this drug has the potential to be transmitted from the mother to the developing fetus.

-Females of reproductive potential should use effective contraception during therapy with this drug and for at least one month after the last dose.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus.

See references

Avelumab Breastfeeding Warnings

Use is not recommended.

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

-The effects in the nursing infant are unknown.
-There is no information regarding the presence of this drug in human milk or the effects on milk production.
-Advise a woman not to breastfeed during treatment and for at least one month after the last dose due to the potential for serious adverse reactions in breastfed infants.

See references

References for pregnancy information

  1. "Product Information. Bavencio (avelumab)." EMD Serono Inc, Rockland, MA.

References for breastfeeding information

  1. "Product Information. Bavencio (avelumab)." EMD Serono Inc, Rockland, MA.

Further information

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