Paclitaxel protein-bound Pregnancy and Breastfeeding Warnings
Paclitaxel protein-bound is also known as: Abraxane
Paclitaxel protein-bound Pregnancy Warnings
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.
Paclitaxel protein-bound particles have been assigned to pregnancy category D by the FDA. 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. Paclitaxel protein-bound particles should only be given during pregnancy when there are no alternatives and benefit outweighs risk.
Paclitaxel protein-bound Breastfeeding Warnings
There are no data on the excretion of paclitaxel protein-bound particles into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions due to paclitaxel protein-bound particles in nursing infants, it is recommended that nursing be discontinued when receiving therapy with paclitaxel protein-bound particles.
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.
- paclitaxel protein-bound Consumer Information
- Pregnancy Support Group
- FDA Pregnancy Categories
- Medicine use during Pregnancy
- Medicine use while Breastfeeding
- Safe Medications during Breastfeeding
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