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Women of childbearing potential/Contraception in males and females: Women of childbearing potential and men have to use effective contraception during and up to 1 month and 3 months after treatment respectively.
Pregnancy: There is no information on the use of Irinotecan in pregnant women. Irinotecan has been shown to be embryotoxic and teratogenic in animals. Therefore, based on results from animal studies and the mechanism of action, Irinotecan should not be used during pregnancy unless clearly necessary.
Lactation: In lactating rats, 14C-Irinotecan was detected in milk. It is not known whether Irinotecan is excreted in human milk. Consequently, because of the potential for adverse reactions in nursing infants, breastfeeding must be discontinued for the duration of Irinotecan therapy.
Fertility: There are no human data on the effect of Irinotecan on fertility. In animals adverse effects of Irinotecan on the fertility of offspring has been documented.
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