Docetaxel Pregnancy and Breastfeeding Warnings

Docetaxel is also known as: Docefrez, Taxotere

Docetaxel Pregnancy Warnings

Docetaxel has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxicity and fetotoxicity in rabbits and rats. There are no controlled data in human pregnancy. If this drug 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 or potential risk for loss of the pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant during therapy. Docetaxel should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Decreased testicular weights were reported in rats when docetaxel was administered in multiple intravenous doses up to 0.3 mg/kg (approximately 1/50th the recommended human dose on a mg/m2 basis). A 10-cycle toxicity study in rats (5 mg/kg) and dogs (0.375 mg/kg) showed testicular atrophy or degeneration. An increased frequency of dosing in rats also produced similar effects at lower dose levels.

Docetaxel Breastfeeding Warnings

There are no data on the excretion of docetaxel into human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants, mothers should discontinue nursing prior to administration of docetaxel.

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