Pregnancy & Lactation : הריון/הנקה

4.6 Pregnancy and Lactation
Pregnancy
Methotrexate is contraindicated during pregnancy (see section 4.3). In animal studies, methotrexate has shown reproductive toxicity, especially during the first trimester (see section 5.3). Methotrexate has been shown to be teratogenic to humans; it has been reported to cause fetal death and/or congenital abnormalities. Exposure of a limited number of pregnant women (42) resulted in an increased incidence (1:14) of malformations (cranial, cardiovascular and extremital). If methotrexate is discontinued prior to conception, normal pregnancies have been reported.
must not get pregnant during methotrexate therapy and patients of a sexually mature age (women and men) must use effective contraception during treatment with Methotrexat “Ebewe” and at least 6 months thereafter (see section 4.4). If, nevertheless, pregnancy occurs during this period, medical advice should be given regarding the risk of harmful effects on the child associated with treatment.
As methotrexate can be genotoxic, all women who wish to become pregnant are advised to consult a genetic counseling centre, if possible, already prior to therapy, and men should seek advice about the possibility of sperm preservation before starting therapy.
Lactation
As methotrexate passes into breast milk and may cause toxicity in nursing infants, treatment is contraindicated during the lactation period (see section 4.3). If use during the lactation period should become necessary, breast-feeding is to be stopped prior to treatment.