Vorinostat Pregnancy and Breast Feeding Warnings

Vorinostat is also known as: Zolinza

Overview

Vorinostat has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vorinostat while you are pregnant. It is not known if Vorinostat is found in breast milk. Do not breast-feed while taking Vorinostat .

Vorinostat Pregnancy Warnings

Vorinostat has been assigned to pregnancy category D by the FDA. Animal studies have revealed that vorinostat crosses the placenta and is found in fetal plasma at levels up to 50% of maternal concentrations. Treatment-related developmental effects including decreased mean live fetal weights, incomplete ossifications of the skull, thoracic vertebra, sternebra, and skeletal variations (cervical ribs, supernumerary ribs, vertebral count, and sacral arch variations), reductions in mean live fetal weight, an elevated incidence of incomplete ossification of the metacarpals, and a dose-related increase in the incidence of malformations of the gall bladder have been reported in animal studies. There are no controlled data in human pregnancy. Vorinostat should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Vorinostat Lactation Warnings

There are no data on the excretion of vorinostat into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from vorinostat, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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