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 Pharmacology under Actions).
Pemetrexed should not be used during pregnancy unless clearly necessary, after careful consideration of the needs of the mother and the risk for foetus (see Precautions).
Women of childbearing potential must use effective contraception during treatment with Pemetrexed. Pemetrexed can have genetically damaging effects.
Sexually mature males are advised not to father a child during the treatment and up to 6 months thereafter. Contraceptive measures or abstinence are recommended. Owing to the possibility of Pemetrexed treatment causing irreversible infertility, men are advised to seek counselling on sperm storage before starting treatment.
It is not known whether Pemetrexed is excreted in human milk and adverse effects on the suckling child cannot be excluded. Breast-feeding must be discontinued during Pemetrexed (see Contraindications).
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).