Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
During pregnancy Alexan should only be administered after a particularly strict indication, while carefully considering the risk/benefit ration for the mother and the foetus.

As cytarabine has shown mutagenic and teratogenic effects in certain animals, the possibility of pregnancy must be ruled out. Cytarabine is only to be used in women who are pregnant or could become pregnant after a careful consideration of the possible risks and benefits.

Due to the potential for anomalies in cytotoxic therapy, especially during the first trimester, the patient who is or may become pregnant during cytarabine treatment should be informed about the potential risk for the foetus and the advisability of continuing the pregnancy. There is a clear although significantly reduced risk if the therapy is started in the second or third trimester. Although normal infants were born by patients who were treated in all three trimesters, follow-up care for such infants is advisable.

Sufficient contraception must be provided to male and female patients of child-bearing age during and 6 months after treatment with Alexan.

If a pregnancy occurs during Alexan therapy, genetic counselling must be provided (see section 5.3).

Breast-feeding
Cytarabine must not be used during breast-feeding.
Breast-feeding must be discontinued before beginning treatment with Alexan.

Fertility
Fertility studies to evaluate the reproductive toxicity of cytarabine have not been conducted. In patients receiving cytarabine (especially in combination with alkylating agents), gonadal suppression leading to amenorrhoea and azoospermia may occur. In general, the effects seem to be connected to the dose and the duration of the therapy and irreversible (see section 4.8). As cytarabine has mutagenic potential that can lead to severe chromosomal damage in male spermatozoa, men treated with cytarabine and their partners should be instructed to use reliable contraceptive methods. Men should not father children during treatment and for up to six months after completion of treatment.
Furthermore, they should be informed before treatment about the possibility of sperm preservation, as cytarabine therapy may cause irreversible infertility.