Pregnancy & Lactation : הריון/הנקה

4.6     Fertility, pregnancy and lactation

Pregnancy
To date there is no available information on safety of use in pregnant women. In animal studies, reproductive toxicity was observed. Consequently, oxaliplatin is not recommended during pregnancy and in women of childbearing potential not using contraceptive measures.
The use of oxaliplatin should only be considered after suitably apprising the patient of the risk to the foetus and with the patient’s consent.

Contraception in males and females
Appropriate contraceptive measures must be taken during and after cessation of therapy during 4 months for women and 6 months for men.

Breast-Feeding
Excretion in breast milk has not been studied. Breast-feeding is contra-indicated during oxaliplatin therapy.

Fertility
Genotoxic effects were observed with oxaliplatin in the preclinical studies. Therefore male patients treated with oxaliplatin are advised not to father a child during and up to 6 months after treatment and to seek advice on conservation of sperm prior to treatment because oxaliplatin may have an anti-fertility effect which could be irreversible.
Women should not become pregnant during treatment with oxaliplatin and should use an effective method of contraception.

Oxaliplatin may have an anti-fertility effect.