Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Women of childbearing potential / Contraception in males and females Pemetrexed can have genetically damaging effects. Women of childbearing potential must use effective contraception during treatment with pemetrexed and for 6 months following completion of treatment. Sexually mature males are advised to use effective contraceptive measures and not to father a child during the treatment, and up to 3 months thereafter.

Pregnancy
There are no data from the use of pemetrexed in pregnant women, but pemetrexed, like other anti-metabolites, is suspected to cause serious birth defects when administered during pregnancy. Animal studies have shown reproductive toxicity (see section 5.3). Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).

Breast-feeding
It is unknown whether pemetrexed is excreted in human milk and adverse reactions on the breast-feeding child cannot be excluded. Breast-feeding must be discontinued during pemetrexed therapy (see section 4.3).

Fertility
Owing to the possibility of pemetrexed treatment causing irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment.