Sunitinib 12.5 Eurodrug Use In Pregnancy & Lactation

Contraception in males and females: Women of childbearing potential should be advised to use effective contraception and avoid becoming pregnant while receiving treatment with sunitinib.
Pregnancy: There are no studies in pregnant women using sunitinib. Studies in animals have shown reproductive toxicity including foetal malformations (see Pharmacology: Toxicology: Preclinical safety data under Actions). Sunitinib should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the foetus. If sunitinib is used during pregnancy or if the patient becomes pregnant while on treatment with sunitinib, the patient should be apprised of the potential hazard to the foetus.
Breast-feeding: Sunitinib and/or its metabolites are excreted in rat milk. It is not known whether sunitinib or its primary active metabolite is excreted in human milk. Because active substances are commonly excreted in human milk and because of the potential for serious adverse reactions in breast-feeding infants, women should not breast-feed while taking sunitinib.
Fertility: Based on nonclinical findings, male and female fertility may be compromised by treatment with sunitinib (see Pharmacology: Toxicology: Preclinical safety data under Actions).