Section 4.6 — Fertility, pregnancy and lactation

Pregnancy There are no adequate data on the use of Veraxanib in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Veraxanib is not recommended during pregnancy unless the clinical condition requires treatment with Veraxanib. If used during pregnancy, or if the patient becomes pregnant while receiving Veraxanib, the patient should be apprised of the potential hazard to the foetus. Women of childbearing potential / Contraception Women of childbearing potential must use effective non-hormonal contraception during treatment and for at least one month after stopping Veraxanib (see section 4.5). Male patients with female partners of childbearing potential should use effective contraception during treatment and for at least one month after stopping Veraxanib. Breast-feeding It is unknown whether veraxanib is excreted in human milk. A risk to the suckling child cannot be excluded. Breast-feeding should be discontinued during treatment with Veraxanib and for one month following the final dose. Fertility Based on animal studies, Veraxanib may impair male fertility (see section 5.3). No data on the effect of Veraxanib on female human fertility are available.