Alkeran Use In Pregnancy & Lactation

Pregnancy: There are no data from the use of ALKERAN in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). In view of its mutagenic properties and structural similarity to known teratogenic compounds, it is possible that ALKERAN could cause congenital defects in the offspring of patients treated with the drug.
ALKERAN should not be used during pregnancy and particularly during the first trimester, unless considered absolutely essential by the physician. In any individual case the potential hazard to the foetus must be balanced against the expected benefit to the mother.
As with all cytotoxic chemotherapy, adequate contraceptive precautions should be practised when either partner is receiving ALKERAN.
Breast‑feeding: Mothers receiving ALKERAN should not breastfeed (see Contraindications).
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 (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, it is possible that ALKERAN may cause temporary or permanent sterility in male patients.
It is recommended that men who are receiving treatment with ALKERAN not father a child during treatment and up to 6 months afterwards and that they have a consultation on sperm preservation before treatment due to the possibility of irreversible infertility as a result of ALKERAN treatment.