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Fertility, pregnancy and lactation from Summary of Product Characteristics
Pregnancy risk from preclinical data
Clinical trial inclusion and exclusion criteria in monarchE
Advanced or metastatic breast cancer
Clinical trial inclusion and exclusion criteria in the MONARCH trials
Lactation risk in the MONARCH and monarchE trials
Abemaciclib was teratogenic and caused decreased foetal weight at maternal exposures similar to the recommended human dose.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
Abemaciclib is not recommended during pregnancy and in women of child-bearing potential not using contraception.1
There are no data from the use of abemaciclib in pregnant women. Studies in animals have shown reproductive toxicity.1
The effect of abemaciclib on fertility in humans is unknown. While in rats no effects on male fertility were noted, cytotoxic effects to the male reproductive tract in mice, rats, and dogs indicate that abemaciclib may impair fertility in males. No adverse effects on female reproductive organs in mice, rats, or dogs, nor effects on female fertility and early embryonic development in rats were observed.1
It is unknown whether abemaciclib is excreted in human milk. A risk to breast feeding children cannot be excluded. Patients receiving abemaciclib should not breast-feed.1
Based on findings in animals and its mechanism of action, abemaciclib can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration of abemaciclib during organogenesis was teratogenic and caused decreased fetal weight at maternal exposures that were similar to human clinical exposure based on area under the curve (AUC) at the maximum recommended human dose. There are no available human data informing the drug-associated risk. Pregnant women should be advised of the potential risk to a fetus.2
In the monarchE trial, women of reproductive potential were required to
Patients in the MONARCH 2 trial were required to have postmenopausal status, due to either surgical/natural menopause or ovarian suppression (pre/perimenopausal) (initiated at least 28 days prior to day 1 of cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin.2
Postmenopausal status due to surgical/natural menopause required at least one of the following
If postmenopausal status was due to ovarian suppression with a GnRH agonist, women of reproductive potential must
Patients in the MONARCH 3 trial were required to have postmenopausal status, defined as meeting one of the following conditions
Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with abemaciclib.4
Women with reproductive potential should use highly effective contraception during abemaciclib treatment and for 3 weeks after the last dose of abemaciclib.2
There are no data on the presence of abemaciclib in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from abemaciclib, advise lactating women not to breastfeed during abemaciclib treatment.2
Studies to assess the effects of abemaciclib on fertility have not been performed. In repeat-dose toxicity studies up to 3-months duration, abemaciclib-related findings in the testis, epididymis, prostate, and seminal vesicle at doses ≥10 mg/kg/day in rats and ≥0.3 mg/kg/day in dogs included
These doses in rats and dogs resulted in approximately 2 and 0.02 times, respectively, the exposure (AUC) in humans at the maximum recommended human dose.2
Abemaciclib may impair fertility in males of reproductive potential.2
1Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Johnston SRD, Harbeck N, Hegg R, et al; monarchE Committee Members and Investigators. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2−, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987-3998. https://doi.org/10.1200/JCO.20.02514
4Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
Date of Last Review: 26 September 2023