Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and breast-feeding

Contraception in men and women
Due to the genotoxic potential of fluorouracil (see Section 5.3), women of childbearing potential should use effective contraception during therapy with fluorouracil and for up to 6 months after the end of treatment.
Men are advised to use effective contraception and not to father a child during therapy with fluorouracil and up to 3 months after the end of treatment.

Pregnancy
There are no adequate and well-controlled studies in pregnant women; however, fetal defects and miscarriages have been reported.

Women of childbearing potential should be advised to avoid pregnancy and to use effective contraception during and up to 6 months after the conclusion of treatment with fluorouracil.

If this drug is used during pregnancy, or if the woman becomes pregnant whilst on therapy with this drug, she should be fully informed of the potential hazard to the fetus, and advised to undergo genetic counseling.
Fluorouracil should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Breast-feeding
Women should not breast-feed during treatment.

Fertility
Fluorouracil may have mutagenic effects. Therefore, men treated with fluorouracil are advised not to father a child during treatment and up to 3 months thereafter.