Cabazitaxel Pregnancy and Breastfeeding Warnings

Cabazitaxel is also known as: Jevtana

Cabazitaxel Pregnancy Warnings

Cabazitaxel has been assigned to pregnancy category D by the FDA. Animal studies have revealed evidence of embryotoxic, fetotoxic, and abortifacient effects. There are no controlled data in human pregnancy. If cabazitaxel is used during pregnancy, or if the patient becomes pregnant while receiving cabazitaxel, the patient should be warned of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy.

In animal studies, cabazitaxel has been shown to cross the placenta. Administration to female rats during organogenesis resulted in maternal and embryofetal toxicity consisting of decreased fetal birth weight, delayed skeletal ossification, increased postimplantation loss, embryolethality, and fetal deaths.

Cabazitaxel Breastfeeding Warnings

Approximately 1.5% of the dose administered to the mother is expected to be excreted into maternal milk.

There are no data on the excretion of cabazitaxel into human milk; however, cabazitaxel and its metabolites are excreted into the milk of lactating rats. The effects in the nursing infant are unknown. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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