Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Contraception in males and females

Due to the genotoxic potential of fluorouracil, women of childbearing potential should use effective contraceptive measures while being treated with fluorouracil and for 7 months following completion of treatment.

Men are recommended to use effective contraceptive measures and to not father a child while receiving fluorouracil and for 4 months following completion of treatment.

Pregnancy

There are no adequate data from the use of topical fluorouracil in pregnant women.

Studies in animals have shown that fluorouracil is teratogenic (see section 5.3). The potential risk for humans is unknown, hence Efudix Cream 5% should not be used during pregnancy (see section 4.3).


Women of childbearing potential should not become pregnant during topical fluorouracil therapy and should use effective method of contraception during treatment with fluorouracil therapy. If a pregnancy occurs during treatment the patient should be advised about the risk for the child of adverse effects associated with the treatment and genetic counselling is recommended.

Breast-feeding

No information is available on the excretion of fluorouracil into breast milk.
Studies in animals have shown the fluorouracil is teratogenic (see section 5.3). A risk to the suckling child cannot be excluded, so Efudix Cream 5% should not be used in nursing mothers (see section 4.3). If use during breastfeeding is absolutely necessary, breastfeeding must be discontinued.

Fertility

No clinical data in humans are available on the effects of Efudix Cream 5% on fertility.

Experiments in various species revealed an impairment of the fertility and reproductive performance of systemic 5-fluorouracil. The reduced systemic exposure to 5-FU following its topical administration will reduce the potential toxicity. The use of topical 5-fluorouracil may impair female and male fertility. Topical fluorouracil is not recommended in men attempting to father a child.
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