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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.
Pregnancy
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
References
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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