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Diarrhoea is the most common adverse reaction.1
Incidence was greatest during the first month of abemaciclib treatment and was lower subsequently. 1
Across clinical studies, median time to onset of the first diarrhoea event was approximately 6 to 8 days, and median duration of diarrhoea was 9 to 12 days (Grade 2) and 6 to 8 days (Grade 3). 1
Diarrhoea can be associated with dehydration.1
Patients should start treatment with antidiarrhoeal agents such as loperamide at the first sign of loose stools, increase oral fluids and notify their healthcare provider.1
Dose modification is recommended for patients who develop ≥ Grade 2 diarrhoea.1
Diarrhoea returned to baseline or lesser grade with supportive treatment such as loperamide and/or dose adjustment.1
For patients taking abemaciclib, current information supports the monitoring of patients and treating diarrhoea reactively (ie if and when they experience diarrhoea) rather than routine preventive administration of anti-diarrhoeal medications.2
The National Cancer Institute provides additional dietary guidance for the management of diarrhoea including foods or drinks to avoid.3
Dosing modification and management of diarrhea is presented in Table 1. Abemaciclib Dose Modification and Management - Diarrhoea .
In severe diarrhea (grade ≥3), consider measuring
neutrophil counts, and
For patients with severe diarrhea or any grade of diarrhea associated with severe nausea or vomiting,
carefully monitor the patients, and
provide IV hydration and electrolyte replacement.4
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.4
Table 1. Abemaciclib Dose Modification and Management - Diarrhoea 1
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. NCI – cancer.gov: https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=446564 https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=446564
CTCAE = Common Terminology Criteria for Adverse Events
▼ 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 2018 M08 01