Women of child-bearing 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 data from the use of irinotecan in pregnant women. IRINOL should not be used during pregnancy unless clearly necessary.
Breast-feeding: It is not known whether irinotecan is excreted in human milk. Consequently, because of the potential for adverse reactions in nursing infants, breast-feeding should be discontinued for the duration of IRINOL therapy.
Fertility: There are no human data on the effect of irinotecan on fertility.