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Pregnancy: There are no data on the use of sorafenib in pregnant women. Studies in animals have shown reproductive toxicity including malformations. In rats, sorafenib and its metabolites were demonstrated to cross the placenta and sorafenib is anticipated to cause harmful effects on the fetus. Sorafenib should not be used during pregnancy unless clearly necessary, after careful consideration of the needs of the mother and the risk to the fetus.
Women of childbearing potential must use effective contraception during treatment.
Lactation: It is not known whether sorafenib is excreted in human milk. In animals, sorafenib and/or its metabolites were excreted in milk. Because sorafenib could harm infant growth and development, women must not breastfeed during sorafenib treatment.
Fertility: Results from animal studies further indicate that sorafenib can impair male and female fertility.
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