Bendamustine Kabi Use In Pregnancy & Lactation

Pregnancy: There are insufficient data from the use of bendamustine in pregnant women. In nonclinical studies bendamustine was embryo-/fetolethal, teratogenic and genotoxic. During pregnancy bendamustine should not be used unless clearly necessary. The mother should be informed about the risk to the foetus. If treatment with bendamustine 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 counselling should be considered.
Lactation: It is not known whether bendamustine passes into the breast milk, therefore, bendamustine is contraindicated during breast feeding. Breast feeding must be discontinued during treatment with bendamustine.
Fertility: Women of childbearing potential must use effective methods of contraception both before and during bendamustine therapy.
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 bendamustine.