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Epirubicin Pregnancy and Breastfeeding Warnings

Epirubicin is also known as: Ellence, Pharmorubicin PFS, Pharmorubicin RDF

Overview

Epirubicin has been shown to cause harm to the human fetus. Do not become pregnant while using Epirubicin. If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Epirubicin during pregnancy. It is unknown if Epirubicin is excreted in breast milk. Do not breast-feed while taking Epirubicin.

Epirubicin Pregnancy Warnings

Epirubicin has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity, teratogenicity, and fetal growth retardation. Numerous external, visceral, and skeletal malformations have been reported. Animals studies at a maternally toxic dose reported increased abortions and delayed ossification. There are no controlled data in human pregnancy. Epirubicin is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Two pregnancies have been reported in women receiving epirubicin. The first woman experienced a spontaneous abortion. The second woman delivered a healthy baby at 35 weeks.

Epirubicin Breastfeeding Warnings

Animal data have reported that the drug is excreted into animal milk.

There are no data on the excretion of epirubicin into human milk. Because many drugs (including other anthracyclines) are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it is recommended that mothers discontinue nursing prior to initiation of therapy with epirubicin.

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