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Women of childbearing potential should avoid becoming pregnant while being treated with BORTEZOMIB.
Bortezomib was not teratogenic in nonclinical developmental toxicity studies in animals.
Bortezomib was not teratogenic in nonclinical developmental toxicity studies in rats and rabbits at the highest dose tested [0.075 mg/kg (0.5 mg/m2) in the rat and 0.05 mg/kg (0.6 mg/m2) in the rabbit] when administered during organogenesis. These dosages are approximately half the clinical dose of 1.3 mg/m2 based on body surface area.
Pregnant rabbits given bortezomib during organogenesis at a dose of 0.05 mg/kg (0.6 mg/m2) experienced significant post-implantation loss and decreased number of live fetuses. Live fetuses from these litters also showed significant decreases in fetal weight. The dose is approximately 0.5 times the clinical dose of 1.3 mg/m2 based on body surface area.
No placental transfer studies have been conducted with bortezomib. There are no adequate and well-controlled studies in pregnant women. If BORTEZOMIB is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus.
Patients should be advised to use effective contraceptive measures to prevent pregnancy and to avoid breast feeding during treatment with BORTEZOMIB.
Nursing Mothers: It is not known whether bortezomib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from BORTEZOMIB, women should be advised against breast feeding while being treated with BORTEZOMIB.
