Vabysmo Use In Pregnancy & Lactation

Fertility: No reproductive or fertility studies have been conducted. No effects on reproductive organs or fertility were observed in a 6-month cynomolgus monkey study with VABYSMO. 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 (see Pharmacology: Toxicology: Preclinical safety data: Impairment of fertility under Actions).
Contraception: Women of childbearing potential should use contraception during treatment with VABYSMO and for at least 3 months following the last dose of VABYSMO.
Pregnancy: There are no data from the use of VABYSMO in pregnant women.
No adverse effects were observed in a study in pregnant cynomologus monkeys given VABYSMO intravenously throughout the period of organogenesis at doses achieving more than 500 times the predicted systemic human exposure of VABYSMO after treatment of a single eye (see Pharmacology: Toxicology: Preclinical safety data: Reproductive toxicity under Actions).
It is not known whether VABYSMO 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, VABYSMO should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus.
Labor and Delivery: The safe use of VABYSMO during labor and delivery has not been established.
Lactation: It is not known whether VABYSMO is excreted in human breast milk. No studies have been conducted to assess the impact of 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 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 VABYSMO and any potential adverse effects on the breastfed child from VABYSMO.