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Verzenios ® ▼ (abemaciclib)
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Verzenios Summary of Product Characteristics (SmPC)
Verzenios® ▼ (abemaciclib): Use in Pregnancy and Lactation and Effect on Fertility
In animal studies, Verzenios (abemaciclib) caused fetal harm and impaired fertility in males. Advise women not to breastfeed and to use contraception.
Abemaciclib was teratogenic and caused decreased foetal weight at maternal exposures similar to the recommended human dose.1
There are no data from the use of abemaciclib in pregnant women. Studies in animals have shown reproductive toxicity.1
Verzenios is not recommended during pregnancy and in women of child-bearing potential not using contraception.1
Women of childbearing potential should use highly effective contraception methods (e.g. double‑barrier contraception) during treatment and for at least 3 weeks after completing therapy.1
Breast-Feeding
It is unknown whether abemaciclib is excreted in human milk. A risk to newborns/infants cannot be excluded. Patients receiving abemaciclib should not breast-feed.1
Fertility
The effect of abemaciclib on fertility in humans is unknown. In animal studies, no effects on female reproductive organs were observed.1
Cytotoxic effects to the male reproductive tract in rats and dogs indicate that abemaciclib may impair fertility in males.1
1. Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Date of Last Review: January 27, 2020
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