Topoccord 1/Topoccord 4 Use In Pregnancy & Lactation

Women of childbearing potential/Contraception in males and females: Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see Pharmacology: Toxicology: Preclinical safety data under Actions). 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 and for at least six months after cessation of therapy with topotecan. As with all cytotoxic chemotherapy, patients being treated with topotecan must be advised that they or their partner must use an effective method of contraception.
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.
Breastfeeding: Topotecan is contra-indicated during breast-feeding (see Contraindications). 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 Pharmacology: Toxicology: Preclinical safety data under Actions). However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.