Verzenios ® (abemaciklib)

För fullständig produktresumé för Verzenios se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Verzenios® ▼ (abemaciclib): Användning vid graviditet och amning och effekt på fertilitet

I djurstudier orsakade Verzenios (abemaciclib) fosterskador och nedsatt fertilitet hos handjur. Rekommendera kvinnor att använda preventivmedel, samt att inte amma.

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.

Datum fӧr senaste ӧversyn 2020 M01 27


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