Ribomustin Use In Pregnancy & Lactation

Pregnancy: There are insufficient data from the use of Ribomustin in pregnant women. In non-clinical studies bendamustine was embryo-/fetolethal, teratogenic and genotoxic (see Pharmacology: Toxicology: Non-Clinical Information under Actions). Women of childbearing potential must use effective methods of contraception both before, during, and one month following Ribomustin therapy.
During pregnancy Ribomustin should not be used unless the benefit outweighs the risk. The mother should be informed about the risk to the fetus. If treatment with Ribomustin is absolutely necessary during pregnancy or if pregnancy occurs during treatment, the patient should be informed about the risks for the unborn child and be monitored carefully. The possibility of genetic counseling should be considered.
Breast-feeding: It is not known whether bendamustine passes into the breast milk, therefore, Ribomustin is contraindicated during breast-feeding (see Contraindications). Breast-feeding must be discontinued during treatment with Ribomustin.
Fertility: Men being treated with bendamustine are advised not to father a child during and for up to 6 months following cessation of treatment. Advice on conservation of sperm should be sought prior to treatment because of the possibility of irreversible infertility due to therapy with Ribomustin.