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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).
How do I manage the Verzenios® (abemaciclib) side effect diarrhoea?
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
Monitoring of Patients with Diarrhoea
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.4
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.4
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
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
3Hurvitz 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. http://dx.doi.org/10.1158/1538-7445.SABCS16-S4-06.
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: 29 March 2021