Verzenios ® (abemaciklib)

För fullständig produktresumé för Verzenios se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Hur hanterar man Verzenios® ▼ (abemaciclib) behandlingsrelaterad diarré ?

Vid första tecknet på lös avföring, börja behandlingen med diarrémedel som loperamid och öka oral vätska. Dosjusteringar rekommenderas hos patienter som utvecklar ≥ grad 2-diarré.

Dose Modification and Management of Diarrhoea

Please find recommendations for dose modifications to manage diarrhoea presented in Table 1. You will find the respective definitions of the Common Terminology Criteria for Adverse Events (CTCAE) displayed in the Table 2.

Table 1.   Management recommendations for diarrhoea1

Toxicitya

Management recommendations

Grade 1

No dose adjustment is required.

Grade 2

If toxicity does not resolve within 24 hours to Grade 1 or less, suspend dose until resolution.

Dose reduction is not required.

Grade 2 that persists or recurs after resuming the same dose despite maximal supportive measures

Suspend dose until toxicity resolves to Grade 1 or less.

Resume at next lower dose.


Grade 3 or 4 or requires hospitalisation

a NCI CTCAE

Monitoring of Patients with Diarrhoea

For patients taking abemaciclib, current information supports the monitoring of patients and treating diarrhea reactively (ie, if and when they experience diarrhea) rather than routine preventative administration of antidiarrheal medications.2,3

In severe diarrhea, consider measuring neutrophil counts and body temperature. 

Carefully monitor and provide IV hydration and electrolyte replacement to patients who 

  • experience severe diarrhoea, or

  • experience any grade of diarrhoea associated with severe nausea or vomiting.

In clinical trials, for patients who require IV hydration or who have diarrhea associated with neutropenia or fever, administer broad-spectrum antibiotics, such as fluoroquinolones.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 diarrhoea.1

The incidence was greatest during the first month of abemaciclib treatment and was lower subsequently. 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

  • 9 to 12 days (Grade 2), and

  • 6 to 8 days (Grade 3). 1

Diarrhoea returned to baseline or lesser grade with supportive treatment such as loperamide and/or dose adjustment.1

References

1. Verzenios [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Hurvitz 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.

3. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

4. US 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

Appendix: CTCAE Grade Definitions - Diarrhoea

In the abemaciclib clinical trials, toxicities were graded according to the NCI CTCAE Version 4.03.3

The grade definitions for the adverse event of diarrhea are shown in Table 2

Table 2. NCI CTCAE Grade Definitions4

Adverse Event

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

Diarrhea (a disorder characterized by frequent and watery bowel movements)

Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline

Increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline

Increase of ≥7 stools per day over baseline; incontinence; hospitalization indicated; severe increase in ostomy output compared to baseline; limiting self-care ADL

Life-threatening consequences; urgent intervention indicated

Death

Abbreviations: ADL = Activities of Daily Living; CTCAE = Common Terminology Criteria for Adverse Events; NCI = National Cancer Institute.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn March 29, 2021


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