Pregnancy: There are no data regarding the use of axitinib in pregnant women. Based on the pharmacological properties of axitinib, it may cause foetal harm when administered to a pregnant woman. Studies in animals have shown reproductive toxicity including malformations (see Pharmacology: Toxicology: Preclinical safety data under Actions). Axitinib should not be used during pregnancy unless the clinical condition of the woman requires treatment with this medicinal product.
Women of childbearing potential must use effective contraception during and up to 1 week after treatment.
Breast-feeding: It is unknown whether axitinib is excreted in human milk. A risk to the suckling child cannot be excluded. Axitinib should not be used during breast-feeding.
Fertility: Based on non-clinical findings, axitinib has the potential to impair reproductive function and fertility in humans (see Pharmacology: Toxicology: Preclinical safety data under Actions).