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Women of childbearing potential: Female patients of childbearing potential should use effective contraception during treatment with Vabysmo and for at least 3 months following the last intravitreal injection of Vabysmo.
Pregnancy: There are no or limited amount of data from the use of faricimab in pregnant women. Systemic exposure after ocular administration of Vabysmo is very low. Animal studies in pregnant cynomolgus monkeys did not indicate direct or indirect harmful effects with respect to reproductive toxicity including embryo-foetal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
As a precautionary measure it is preferable to avoid the use of Vabysmo during pregnancy unless the potential benefit outweighs the potential risk to the foetus.
Breast-feeding: It is unknown whether faricimab is excreted in human milk. A risk to the breast-fed newborn/infant cannot be excluded. Vabysmo is not recommended during breast-feeding. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Vabysmo therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No effects on reproductive organs or fertility were observed in a 6-month cynomolgus monkey study with faricimab (see Pharmacology: Toxicology: Preclinical safety data under Actions).
