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Fulvestrant Pregnancy and Breastfeeding Warnings

Fulvestrant is also known as: Faslodex

Fulvestrant Pregnancy Warnings

Fulvestrant has been assigned to pregnancy category D by the FDA. Animal studies of doses at or below recommended human doses have revealed evidence of fetal abnormalities and death. There are no controlled data in human pregnancy. Fulvestrant is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. If fulvestrant is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be apprised of the potential hazard to the fetus, or potential risk for loss of the pregnancy.

Fulvestrant Breastfeeding Warnings

There are no data on the excretion of fulvestrant into human milk. Fulvestrant is found in rat milk at levels significantly higher than plasma after administration of 2 mg/kg. 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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