Vabysmo Use In Pregnancy & Lactation

Females and Males of Reproductive Potential: Fertility: No reproductive or fertility studies have been conducted. No effects on reproductive organs were observed in a 6-month cynomolgus monkey study at faricimab doses up to 3 mg/eye (8-10x clinical exposures based on AUC). VEGF inhibition has been shown to affect follicular development, corpus luteum function and fertility. Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development, however the risk is considered low due to the low systemic exposure after ocular administration.
Contraception: Women of childbearing potential should use effective contraception during treatment with Faricimab (Vabysmo) and for at least 3 months following the last dose of Faricimab (Vabysmo).
Pregnancy: There is no data from the use of Faricimab (Vabysmo) in pregnant women.
No adverse effects were observed in a study in pregnant cynomolgus monkeys (see Pharmacology: Toxicology: Nonclinical Safety: Reproductive toxicity under Actions).
VEGF inhibition has been shown to cause malformations, embryo-fetal resorption, and decreased fetal weight. VEGF inhibition has also been shown to affect follicular development, corpus luteum function, and fertility. No dedicated studies addressing the effects of Ang-2 inhibition on pregnancy are available. Based on non-clinical data, Ang-2 inhibition may lead to effects comparable to VEGF inhibition. Systemic exposure after ocular administration of Faricimab (Vabysmo) is very low.
It is not known whether faricimab can cross the placenta or cause harm to the fetus when administered to pregnant women. Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development. Although the systemic exposure after ocular administration is very low, faricimab should not be used during pregnancy unless that treatment is required due to the clinical condition of the woman.
Labor and delivery: The safe use of Faricimab (Vabysmo) during labor and delivery has not been established.
Lactation: It is not known whether Faricimab (Vabysmo) is excreted in human breast milk. No studies have been conducted to assess the impact of Faricimab (Vabysmo) on milk production or its presence in breast milk. Because many drugs are excreted in human milk with the potential for absorption and harm to infant growth and development exists, caution should be exercised when Faricimab (Vabysmo) is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Faricimab (Vabysmo) and any potential adverse effects on the breastfed child from Faricimab (Vabysmo).