Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Pregnancy
As with all chemotherapies containing cytostatics, appropriate contraceptive measures must be taken when one of the partners receive melphalan. If pregnancy occurs during treatment, the possibility of genetic counseling should be used.
Melphalan has a mutagenic effect on the development of an embryo. Melphalan should not be used during pregnancy, especially during the first trimester. In the case of a vital indication for the treatment of a pregnant patient, medical advice should be given on the risk of harm to the child associated with the treatment.
Breast-feeding
Do not breastfeed during treatment with Melphalan.
Fertility
Melphalan causes suppression of ovarian function in premenopausal women resulting in amenorrhoea in a significant number of patients.
Melphalan has a mutagenic effect in animal models; in patients treated with the drug, chromosomal aberrations were observed. Therefore, men treated are advised not to produce a child during treatment with melphalan and up to 6 months afterwards, and to consult a sperm reserve before the start of treatment because of the possibility of an irreversible infertility caused by the treatment (see section 5.3).
There is evidence from some animal studies that Melphalan can have an undesirable effect on spermatogenesis.
Therefore, it is possible that Melphalan may cause temporary or permanent sterility in male patients.