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Epirubicin Pregnancy and Breastfeeding Warnings

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

Epirubicin Pregnancy Warnings

FDA pregnancy category: D Use of epirubicin is not recommended unless there are no alternatives and benefit outweighs risk. Comments: Women of childbearing potential should be advised to avoid becoming pregnant during treatment and should use effective contraceptive methods. Males with female sexual partners of childbearing potential should use contraception during and after cessation of therapy.

Animal studies have revealed evidence of embryotoxicity, teratogenicity, and fetal growth retardation. Numerous external, visceral, and skeletal malformations have been reported. Animal studies at a maternally toxic dose reported increased abortions and delayed ossification. Epirubicin may damage testicular tissue and sperm. Possible sperm DNA damage raises concerns about loss of fertility and genetic abnormalities in fetuses. 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. FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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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