Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Cytarabine is presumed to cause severe damages to the unborn child if administered during pregnancy. Cytarabine must not be administered during pregnancy unless this is imperative (vital indication). In the case of treatment of a pregnant patient, medical consultation regarding the risk of foetal damage associated with treatment should take place.
Women should not become pregnant during treatment with ARA-cell®. Women have to use effective contraception during and up to 6 months after treatment.

If a pregnancy does occur during treatment, appropriate genetic counselling should be utilised.
Breast-feeding is prohibited during treatment.

Cytarabine may have a mutagenic effect which could induce chromosomal damage in the human spermatozoa.
Fertility studies to assess the reproductive toxicity of cytarabine have not been conducted.
Gonadal suppression, resulting in amenorrhea or azoospermia, may occur in patient taking cytarabine therapy, especially in combination with the alkylating agents. In general, these effects appear to be related to dose and length of therapy and may be irreversible. It is therefore recommended that men treated with ARA-cell® do not father a child during and up to six months after the start of treatment as well as seek advice regarding semen cryopreservation before start of treatment due to possible irreversible infertility after treatment with ARA-cell®.