Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Pregnancy
There are insufficient data from the use of Demustin in pregnant women. In nonclinical studies bendamustine hydrochloride was embryo-/fetolethal, teratogenic and genotoxic (see section 5.3). During pregnancy Demustin should not be used unless clearly necessary. The mother should be informed about the risk to the foetus. If treatment with Demustin 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.
Fertility
Women of childbearing potential must use effective methods of contraception both before and during Demustin therapy.
Men being treated with Demustin 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 Demustin.


Breast feeding
It is not known whether bendamustine passes into the breast milk, therefore, Demustin is contraindicated during breast feeding (see section 4.3). Breast feeding must be discontinued during treatment with Demustin.