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).
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
Please find recommendations for dose modifications to manage diarrhoea presented in Management recommendations for diarrhoea .
Monitoring of Patients with Diarrhoea
Monitor patients who take abemaciclib and treat diarrhoea if and when it occurs. It is not necessary to give patients prophylactic antidiarrhoeal medications.3,4
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
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
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