Fertility: ALKERAN causes suppression of ovarian function in premenopausal women resulting in amenorrhoea in a significant number of patients.
There is evidence from some animal studies that ALKERAN can have an adverse effect on spermatogenesis. Therefore, it is possible that ALKERAN may cause temporary or permanent sterility in male patients.
Pregnancy: The teratogenic potential of ALKERAN has not been studied. In view of its mutagenic properties and structural similarity to known teratogenic compounds, it is possible that melphalan could cause congenital defects in the offspring of patients treated with the drug.
As with all cytotoxic chemotherapy, adequate contraceptive precautions should be practised when either partner is receiving ALKERAN.
The use of melphalan should be avoided whenever possible during pregnancy, particularly during the first trimester. In any individual case the potential hazard to the foetus must be balanced against the expected benefit to the mother.
Breastfeeding: Mothers receiving ALKERAN should not breast-feed.