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Verzenios ® (abemaciclib)
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How to manage haematologic toxicities under Verzenios® (abemaciclib) in metastatic breast cancer
Dose modification is recommended for patients who develop Grade 3 or Grade 4 haematologic toxicities, including neutropenia, anemia, thrombocytopenia, and leukopenia.
Content Overview
Management Recommendations for Haematologic Toxicities
Please find
- dose modification and management recommendations in Dose modification and management for haematologic toxicities
- grade definitions for haematologic toxicities in NCI CTCAE Grade Definitions
The infographic illustrates the schedule of blood count monitoring and dose modification and management of haematologic toxicity with abemaciclib.
Haematopoietic Growth Factor Support in the MONARCH-2 and MONARCH-3 Studies
Haematopoietic growth factors reduce the risk of febrile neutropenia and the duration and severity of neutropenia.2,3
In the MONARCH 3 and MONARCH 2 studies, doctors were allowed to give growth factors according to the American Society of Clinical Oncology (ASCO) guidelines.3-5
Incidence of Haematologic Toxicities
Please find the incidence of haematologic toxicities with abemaciclib plus endocrine therapy in All Grade Haematologic Toxicities in the Abemaciclib Arms of the MONARCH Clinical Trials.
Event, % |
MONARCH 3 |
MONARCH 2 |
Neutropenia |
41 |
46 |
Anemia |
28 |
29 |
Thrombocytopenia |
10 |
16 |
Leukopenia |
21 |
28 |
Haematologic Toxicity of Special Interest - Neutropenia
Across studies, neutropenia was observed within the first 2 months and did not resolve during the treatment. The neutropenia reversed in patients who discontinued the treatment.8
Below you will find information about the incidence of neutropenia across the MonarchE, MONARCH 2, and MONARCH 3 studies. Please review the Verzenios Summary of Product Characteristics, particularly the section:
• 4.8 Undesirable effects
Grade Definitions According to the National Cancer Institute (NCI) Common Terminology Criteria of Adverse Events (CTCAE)
In the abemaciclib clinical trials, toxicities were graded according to the NCI CTCAE Version 4.03.7
The grade definitions for haematologic toxicities are shown in NCI CTCAE Grade Definitions.
Adverse Event |
Grade 1 |
Grade 2 |
Grade 3 |
Grade 4 |
Neutrophil |
<LLN-1500/mm3; |
<1500-1000/mm3; |
<1000-500/mm3; |
<500/mm3; |
White blood |
<LLN-3000/mm3; |
<3000-2000/mm3; |
<2000-1000/mm3; |
<1000/mm3; |
Anemiac |
<LLN-10.0 g/dL; |
<10.0-8.0 g/dL; |
<8.0 g/dL; |
Life-threatening consequences; |
Platelet |
<LLN-75,000/mm3; |
<75,000-50,000/mm3; |
<50,000-25,000/mm3; |
<25,000/mm3; |
Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events version 4.03; LLN = lower limit of normal; NCI = National Cancer Institute.
aFinding based on laboratory test results that indicate a decrease in number of neutrophils in a blood specimen.
bFinding based on laboratory test results that indicate a decrease in number of white blood cells in a blood specimen.
cDisorder characterized by a reduction in the amount of hemoglobin in 100 ml of blood.
dFinding based on laboratory test results that indicate a decrease in number of platelets in a blood specimen.
References
1Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Crawford J, Ozer H, Stoller R, et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med. 1991;325(3):164-170. https://doi.org/10.1056/NEJM199107183250305
3Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015;33(28):3199-3212. https://doi.org/10.1200/JCO.2015.62.3488
4Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884. https://doi.org/10.1200/JCO.2017.73.7585
5Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646. https://doi.org/10.1200/jco.2017.75.6155
6Rugo HS, Huober J, Llombart-Cussac A, et al. Management of abemaciclib associated adverse events in patients with HR+, HER2- advanced breast cancer: analysis of the MONARCH trials. Poster presented at: Annual Meeting of the European Society for Medical Oncology (ESMO) European Cancer Congress (ECC); October 19-23, 2018; Munich, Germany. Accessed October 21, 2021. https://www.lillymedical.com/en-us/answers/management-of-abemaciclib-associated-adverse-events-in-patients-with-hr-her2-advanced-breast-cancer-analysis-of-the-monarch-trials-88694?hcpToken=A12DSa08bhrd123gg8
7Data on file, Eli Lilly and Company and/or one of its subsidiaries.
8Rugo HS, Huober J, Garcia-Saenz JA, et al. Management of abemaciclib-associated adverse events in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: safety analysis of MONARCH 2 and MONARCH 3. Oncologist. 2021;26(1):e53-e65. http://dx.doi.org/10.1002/onco.13531
9US Department of Health and Human Services, National Institutes of Health, National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE). Version 4.03. May 28, 2009. Updated June 14, 2010. Accessed March 15, 2021. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf
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: 15 October 2024