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Capecitabine Pregnancy and Breastfeeding Warnings

Capecitabine is also known as: Xeloda

Overview

Capecitabine has been shown to cause harm to the fetus. Do not become pregnant while you are taking it. Talk with your doctor about using effective methods of birth control while taking Capecitabine. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Capecitabine while you are pregnant. It is not known if Capecitabine is excreted in breast milk. Do not breast-feed while taking Capecitabine.

Capecitabine Pregnancy Warnings

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

It is recommended that women of childbearing potential be advised to avoid becoming pregnant while receiving treatment with capecitabine. Animal studies on fertility and general reproductive performance have reported that doses of 760 mg/kg/day disturbed estrus and therefore caused a decrease in fertility. When pregnancy occurred, no fetus survived this dose. In male animals, a dose of 760 mg/kg/day caused degenerative changes in the testes, including decreases in the number of spermatocytes and spermatids.

Capecitabine Breastfeeding Warnings

There are no data on the excretion of capecitabine into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, it has been recommended that nursing be discontinued when a patient is receiving capecitabine therapy.

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