Pregnancy & Lactation : הריון/הנקה

4.6         Fertility, pregnancy and lactation

Pregnancy
There are no or a limited amount of data from the use of oxaliplatin in pregnant women. Studies in animals have shown reproductive toxicity(see section 5.3). Consequently, oxaliplatin is not recommended during pregnancy and in women of childbearing potential not using contraception.
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
Due to the genotoxic potential of oxaliplatin (see section 5.3),Women of childbearing potential have to use effective contraception during and up to 9 months after treatment. Men have to use effective contraception during and up to 6 monthsafter treatment.

Breastfeeding
Excretion in human milk has not been studied. Breastfeeding is contraindicated 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 have to use effective contraception.
Oxaliplatin may have an anti-fertility effect.