Tips for searching:
• You have to select a product and type at least 2 words to activate the search
• Use only words that are specific to the information you are looking for
• Avoid typing questions or sentences
Please do not use this field to report adverse events or product complaints. Adverse events and product complaints should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow card in the Google play or Apple app store. Adverse events and product complaints should also be reported to Lilly: please call Lilly UK on 01256 315 000.
Verzenios ® ▼ (abemaciclib)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Can Verzenios® (abemaciclib) be used during pregnancy or lactation?
In animal studies, abemaciclib caused fetal harm and impaired fertility in males. Advise women not to breastfeed and to use contraception.
Fertility, pregnancy and lactation from Summary of Product Characteristics
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
Pregnancy risk from preclinical data
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
Early breast cancer
Clinical trial inclusion and exclusion criteria in monarchE
In the monarchE trial, women of reproductive potential were required to
Advanced or metastatic breast cancer
Clinical trial inclusion and exclusion criteria in the MONARCH trials
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
- prior bilateral oophorectomy
- age ≥60 years
- age <60 years and amenorrheic (nontreatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or chemotherapy) for at least 12 months. Estradiol and follicle-stimulating hormone (FSH) must have been in the postmenopausal range.2
If postmenopausal status was due to ovarian suppression with a GnRH agonist, women of reproductive potential must
- have a negative serum pregnancy test at baseline (within 14 days prior to randomization), and
- agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of study drug.2
Patients in the MONARCH 3 trial were required to have postmenopausal status, defined as meeting one of the following conditions
- prior bilateral oophorectomy
- age ≥60 years
- age <60 years and amenorrheic (nontreatment-induced amenorrhea secondary to tamoxifen, toremifene, ovarian suppression, or chemotherapy) for at least 12 months. Estradiol and FSH must have been in the postmenopausal range.2
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
Lactation risk in the MONARCH and monarchE trials
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
Paternal exposure to abemaciclib in the MONARCH trials
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
- decreased organ weights
- intratubular cellular debris
- tubular dilatation
- atrophy, and
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