Not applicable as ELIGARD is contraindicated in women. Expected hormonal changes that occur with Eligard treatment increase the risk for pregnancy loss. In non-clinical studies in rats, major fetal abnormalities were observed after administration of leuprorelin acetate throughout gestation. There were increased fetal mortality and decreased fetal weights in rats and rabbits. The effects of fetal mortality are expected consequences of the alterations in hormonal levels brought about by this drug. The possibility exists that spontaneous abortion may occur. It is not known whether leuprorelin acetate is excreted into human milk.
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