Women of Childbearing Potential/Contraception in Males and Females: Women of childbearing potential should be advised to avoid becoming pregnant while on ZALTRAP, and should be informed of the potential hazard to the foetus. Women of childbearing potential and fertile males should use effective contraception during and up to a minimum of 6 months after the last dose of treatment.
Pregnancy: There are no data from the use of aflibercept in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). As angiogenesis is critical to foetal development, the inhibition of angiogenesis following administration of ZALTRAP may result in adverse effects on pregnancy. ZALTRAP should be used only if the potential benefit justifies the potential risk during pregnancy. If the patient becomes pregnant while taking ZALTRAP, the patient should be informed of the potential hazard to the foetus.
Breast-feeding: No studies have been conducted to assess the impact of ZALTRAP on milk production, its presence in breast milk or its effects on the breast-fed child.
It is unknown whether aflibercept is excreted in human milk. A risk to the breast-fed child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ZALTRAP therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Male and female fertility are likely to be compromised during treatment with aflibercept based on studies in monkeys (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).