Pregnancy & Lactation : הריון/הנקה

4.6         Fertility, pregnancy and lactation

Pregnancy

There are insufficient data from the use of bendamustine hydrochloride in pregnant women. In nonclinical studies bendamustine hydrochloride was embryo-/fetolethal, teratogenic and genotoxic (see section 5.3). During pregnancy bendamustine hydrochloride should not be used unless clearly necessary. The mother should be informed about the risk to the foetus. If treatment with bendamustine hydrochloride 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 bendamustine hydrochloride therapy.

Men being treated with bendamustine hydrochloride 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 hydrochloride.

Breastfeeding

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