Verzenios ® (abemaciklib)

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Verzenios® ▼ (abemaciclib): Åtgärder vid diarré

Diarré inträffade hos 90,2% av patienterna i abemaciclib-studierna. Behandling med läkemedel mot diarré, t.ex. loperamid, ska påbörjas vid första tecken på lös avföring.

Detailed Information

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

Dose Modification

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

  • body temperature.4

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

Toxicitya

Management recommendations

Grade 1

No dose adjustment 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

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. NCI – cancer.gov: https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=446564 https://www.cancer.gov/publications/dictionaries/cancer-terms?cdrid=446564

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

Glossary

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

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