Contraception in males and females: Male and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Pregnancy: No clinical data are available for bortezomib with regard to exposure during pregnancy. The teratogenic potential of bortezomib has not been fully investigated.
In non-clinical studies, bortezomib had no effects on embryonal/foetal development in rats and rabbits at the highest maternally tolerated doses. Animal studies to determine the effects of bortezomib on parturition and post-natal development were not conducted. Bortezomib should not be used during pregnancy unless the clinical condition of the woman requires treatment with bortezomib.
If bortezomib is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects. Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention program are met. Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention program of thalidomide. Refer to the Summary of Product Characteristics of thalidomide for additional information.
Breast-feeding: It is not known whether bortezomib is excreted in human milk. Because of the potential for serious adverse reaction in breast-fed infants, breast-feeding should be discontinued during treatment with bortezomib.
Fertility: Fertility studies were not conducted with bortezomib.