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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
Diarrhoea is the most common adverse reaction. 85% of patients taking abemaciclib combined with endocrine therapy in the phase-3-clinical trials reported it.1
Most patients develop diarrhoea in the first month of treatment. The number decreased in the following months.1
Across clinical studies, the median time to onset of the first diarrhoea event was approximately 6 to 8 days, and the median duration of diarrhoea was
- 7 to 12 days (Grade 2), and
- 5 to 8 days (Grade 3).1
Diarrhoea returned to baseline or a lesser grade with supportive treatment such as loperamide or dose adjustment, or both.1
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 28, 2020. 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.
Date of Last Review: 30 October 2023