Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Fertility
Gonadal suppression resulting in amenorrhea or azospermia may occur in patients receiving antineoplastic therapy. These effects appear to be related to dose and length of therapy and may be irreversible. Prediction of the degree of testicular or ovarian function impairment is complicated by the common use of combinations of several antineoplastics, which makes it difficult to assess the effects of individual agents.
Men of sexually mature age treated with carboplatin are recommended not to father a child during treatment and up to 6 months afterwards and to ask advice about spermatic preservation prior to initiation of the therapy because of the possibility of irreversible infertility due to therapy with carboplatin.

Carboplatin Teva EM 12/2023 Notification
       Pregnancy
Carboplatin can cause foetal harm when administered to a pregnant woman. Carboplatin has been shown to be embryotoxic and teratogenic in rats receiving the drug during organogenesis. No controlled studies in pregnant women have been conducted. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the foetus. Women with child-bearing potential should be advised to avoid becoming pregnant.

All patients of reproductive age should be advised to use an effective contraceptive method for themselves and/or their sexual partners during therapy and for at least six months after therapy.

For women who are pregnant or become pregnant during therapy, genetic counselling should be provided.

Breast-feeding
It is not known whether carboplatin is excreted in human milk. Because there is a possibility of toxicity in nursing infants secondary to carboplatin treatment of the mother, breast-feeding must be discontinued if the mother is treated with carboplatin.