Pregnancy: There are limited data from the use of eptinezumab in pregnant women. Animal studies with eptinezumab do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Human IgG is known to cross the placental barrier; therefore, eptinezumab may be transmitted from the mother to the developing fetus.
VYEPTI should not be used by pregnant women unless the expected benefit to the mother justifies the potential risk to the fetus.
Breast-feeding: There are no data on the presence of eptinezumab in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be excreted in breast milk; therefore, eptinezumab may be transmitted from the mother to the breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VYEPTI and any potential effects on the breastfed infant.
Fertility: The effect of eptinezumab on human fertility has not been evaluated. Animal studies with eptinezumab showed no impact on female and male fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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