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Pregnancy: Category D.
Adverse effects (fetal loss and decreased fetal weight) were observed in animal reproduction studies at doses less than the equivalent human dose (based on BSA). Women of reproductive potential should avoid becoming pregnant and should use effective contraception during treatment.
Lactation: It is not known whether bortezomib is excreted in human milk. Due to the potential for serious adverse reactions in the breast-feeding infant, the decision to discontinue bortezomib or breast-feeding should take into account the benefits of treatment to the mother.
