Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation
Contraception in men and women
Due to the genotoxic risk of clofarabine (see section 5.3), women of childbearing potential must use effective methods of contraception during treatment with clofarabine and for 6 months following completion of treatment.

Men should use effective methods of contraception and be advised to not father a child while receiving clofarabine, and for 3 months following completion of treatment.

Pregnancy
There are no data on the use of clofarabine in pregnant women. Studies in animals have shown reproductive toxicity including teratogenicity (see section 5.3). Clofarabine may cause serious birth defects when administered during pregnancy. Therefore, Evoltra should not be used during pregnancy, especially not during the first trimester, unless clearly necessary (i.e. only if the potential benefit to the mother outweighs the risk to the foetus). If a patient becomes pregnant during treatment with clofarabine, they should be informed of the possible hazard to the foetus.

Breast-feeding
It is unknown whether clofarabine or its metabolites are excreted in human breast milk. The excretion of clofarabine in milk has not been studied in animals. However, because of the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued prior to, during and following treatment with Evoltra (see section 4.3).

Fertility
Dose related toxicities on male reproductive organs have been observed in mice, rats and dogs, and toxicities on female reproductive organs have been observed in mice (see section 5.3). As the effect of clofarabine treatment on human fertility is unknown, reproductive planning should be discussed with patients as appropriate.