Eribulin Pregnancy and Breastfeeding Warnings

Brand names: Halaven

Medically reviewed by Drugs.com. Last updated on Sep 4, 2025.

Eribulin Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: This drug is only recommended for use during pregnancy when there are no alternatives, and the benefit outweighs the risk.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-Female patients of childbearing potential should be advised to use effective contraception during therapy and for at least 2 weeks after the last dose.
-Males with female partners of childbearing potential should be advised to use effective contraception during therapy and for 3.5 months after the last dose.
-Male fertility may be compromised by this drug.
-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.

Animal studies have revealed evidence of fetal harm including embryofetal death, abortion, reduced fetal weight, minor skeletal anomalies, and severe external or soft tissue malformations such as the absence of a lower jaw, tongue, stomach, and spleen. Maternotoxicity has occurred in rats at or above the recommended human dose including splenomegaly, reduced maternal weight gain, and decreased food consumption. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Eribulin Breastfeeding Warnings

AU, UK: Use is contraindicated.
US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

The effects in the nursing infant are unknown.

See references

Further information

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

Medical Disclaimer