Paclitaxel protein-bound Pregnancy and Breastfeeding Warnings

Paclitaxel protein-bound is also known as: Abraxane

Paclitaxel protein-bound Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and fetotoxicity, as indicated by intrauterine mortality, increased resorptions, reduced numbers of litters and live fetuses, reduction in fetal body weight and increase in fetal anomalies. (Fetal anomalies included soft tissue and skeletal malformations such as eye bulge, folded retina, microphthalmia, and dilation of brain ventricles.) There are no controlled data in human pregnancy. Men should be advised not to father a child while receiving treatment with paclitaxel protein-bound particles. Animal studies of the effects of paclitaxel protein-bound particles on males mating with untreated females were reported to have resulted in significantly reduced fertility accompanied by decreased pregnancy rates and increased loss of embryos in mated females. Testicular atrophy/degeneration and a low incidence of skeletal and soft tissue anomalies were also reported. 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.

FDA pregnancy category: D Paclitaxel protein-bound particles should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Paclitaxel protein-bound Breastfeeding Warnings

A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes

Animal studies have revealed that intravenous administration of carbon-14 labeled paclitaxel on days 9 to 10 postpartum, concentrations of radioactivity in milk were higher than in plasma and declined in parallel with the plasma concentrations.

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