Eribulin Pregnancy and Breastfeeding Warnings

Eribulin is also known as: Halaven

Eribulin Pregnancy Warnings

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.

Eribulin has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryofetal toxicity and teratogenicity. There are no controlled data in human pregnancy. If eribulin is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus.

Eribulin Breastfeeding Warnings

The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the benefit of breast-feeding to the infant and the importance of the drug to the mother. There are no data on the excretion of eribulin into human milk. The effects in the nursing infant are unknown.

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