Biomib Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category D. Bortezomib may cause harm to the fetus. The administration of bortezomib in pregnant rabbits during organogenesis resulted to significant post-implementation loss and decreased number of live fetuses. Embryolethality and decreased fetal weight were demonstrated in rabbits. Placental transfer studies have not been conducted with bortezomib. To date, there are no adequate or well-controlled studies using bortezomib to establish its safety in pregnant women.
Bortezomib should not be used during pregnancy, unless the clinical condition of the woman requires treatment with bortezomib. If bortezomib is used during pregnancy, the patient should be informed of the potential effects of the treatment to the fetus. Thalidomide, a known human teratogenic active substance that causes severe life-threatening birth defects, is contraindicated during pregnancy. Patients receiving bortezomib with thalidomide should adhere to the pregnancy prevention program of thalidomide. (Refer to the Summary of Product Characteristics of thalidomide for additional information.)
Females and Males of Reproductive Potential: Men should be advised not to father a child during and up to three months after bortezomib treatment. Women of childbearing potential should be advised to avoid becoming pregnant during and three months after treatment with bortezomib. If the patient becomes pregnant while taking bortezomib or if the drug is administered during pregnancy, the patient should be informed of the potential harm to the fetus.
Lactation: It is not known whether bortezomib is distributed in human milk. Since there is a possibility of toxicity in nursing infants if the drug was distributed into milk, a decision should be made whether to discontinue bortezomib therapy or breastfeeding, considering that importance of the drug to the patient. Women should also be advised not to breastfeed two months after treatment with bortezomib.