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Verzenios ® (abemaciclib)
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How is diarrhoea with Verzenios® (abemaciclib) managed?
At the first sign of loose stools, start treatment with anti-diarrhoeal agents such as loperamide and increase oral liquids. Dose modifications are recommended in patients who develop ≥ Grade 2 diarrhoea.
Dose modification and management of diarrhoea
Please find recommendations for dose modifications to manage diarrhoea presented in Management recommendations for diarrhoea.
Monitoring of patients with diarrhoea
Early identification and intervention is critical for the optimal management of diarrhoea. Severe diarrhoea has been associated with dehydration and infection. At the first sign of loose stools, patients should be instructed to
Monitor patients who take abemaciclib and treat diarrhoea if and when it occurs. It is not necessary to give patients prophylactic antidiarrhoeal medications.3,5
In severe diarrhoea, consider measuring neutrophil counts and body temperature.
Give broad-spectrum antibiotics, like fluoroquinolones, to patients who require intravenous hydration or who have diarrhoea with neutropenia or fever.3
Carefully monitor and provide intravenois (IV) hydration and electrolyte replacement to patients who
- experience severe diarrhoea, or
- experience any grade of diarrhoea with severe nausea or vomiting.3
Incidence and duration of diarrhoea in clinical studies
Below you will find information about the incidence of diarrhoea across the MonarchE, MONARCH 2, and MONARCH 3 studies. Please review the Verzenios Summary of Product Characteristics, particularly the section:
• 4.8 Undesirable effects
References
1Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2US Department of Health and Human Services; National Institutes of Health and National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Version 4.03. May 28, 2009. Updated June 14, 2010. Accessed April 7, 2025. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
3Data on file, Eli Lilly and Company and/or one of its subsidiaries.
4Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company; 2023.
5Hurvitz S, Martin M, Fernández Abad M, et al. Biological effects of abemaciclib in a phase 2 neoadjuvant study for postmenopausal patients with HR+, HER2- breast cancer. Cancer Res. 2017;77(4 suppl):S4-06. American Association for Cancer Research abstract S4-06. http://dx.doi.org/10.1158/1538-7445.SABCS16-S4-06.
Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.
Date of Last Review: 30 October 2023