Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation
Contraception in males and females
As with all cytotoxic chemotherapy, effective contraceptive methods must be advised when either partner is treated with topotecan.

Women of childbearing potential
Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3). As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of child bearing potential should be advised to avoid becoming pregnant during therapy with topotecan.

Pregnancy
If topotecan is used during pregnancy, or if the patient becomes pregnant during therapy with topotecan, the patient must be warned of the potential hazards to the foetus.

Breast-feeding
Topotecan is contra-indicated during breast-feeding (see section 4.3). Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.

Fertility
No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3). However as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.