Docetaxel Pregnancy and Breastfeeding Warnings

Docetaxel is also known as: Docefrez, Taxotere

Docetaxel Pregnancy Warnings

Use is not recommended. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. -Women of childbearing potential should be advised to avoid becoming pregnant during therapy and for up to 6 months following therapy. -Men being treated with this drug should be advised not to father a child during and for up to 6 months following therapy.

Based on its mechanism of action, this drug is expected to cause fetal harm when administered to pregnant women. Animal studies have revealed evidence of embryotoxicity and fetotoxicity in rabbits and rats. There are no controlled data in human pregnancy. Animal studies have shown decreased testicular weights and testicular atrophy or degeneration. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US 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.

Docetaxel Breastfeeding Warnings

Radiolabeled docetaxel was detected in rat milk; signs of delayed development were seen in the offspring from rats who received IV docetaxel 1.5 mg/m2/day during late gestation and lactation. It is unknown whether this drug is excreted in human milk.

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

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