Verzenio® (Abemaciclib)

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Abemaciclib: Diarrhea Management MBC

Diarrhea occurred in 90.2% of patients in abemaciclib trials, but was manageable with an over-the-counter anti-diarrheal therapy.

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Diarrhea Management

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.1,2

Early identification and intervention is critical for the optimal management of diarrhea. Episodes of diarrhea have been associated with dehydration and infection. At the first sign of loose stools, patients should be instructed to

  • start antidiarrheal therapy (for example, loperamide)
  • increase oral fluids, and
  • notify their healthcare professional for further instructions and appropriate follow-up.2

Follow labeling of selected antidiarrheal agent for dosing instructions. Lilly does not provide recommendations for choice or dosing of antidiarrheal agents.

Dietary Management

The NCI provides additional dietary guidance for the management of diarrhea including foods or drinks to avoid.3

Dose Modification

In severe diarrhea, consider measuring neutrophil counts and body temperature. 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. 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.2

Dosing modification and management of diarrhea is presented in Abemaciclib Dose Modification and Management — Diarrhea.

Abemaciclib Dose Modification and Management — Diarrhea2

At the first sign of loose stools, start treatment with antidiarrheal agents and increase intake of oral fluids.

CTCAE Grade

Abemaciclib Dose Modifications

Grade 1

No dose modification is required.

Grade 2

If toxicity does not resolve within 24 hours to ≤ grade 1, 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.
Resume at next lower dose.

Grade 3 or 4 or requires hospitalization

Suspend dose until toxicity resolves to ≤ grade 1.
Resume at next lower dose.

Abbreviation: CTCAE = Common Terminology Criteria for Adverse Events.

References

1Hurvitz 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.

2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3National Cancer Institute. Eating hints: before, during, and after cancer treatment. NIH Publication No. 18-7157. https://www.cancer.gov/publications/patient-education/eating-hints. Updated January 2018. Accessed January 30, 2020.

Glossary

IV = intravenous

Lilly = Eli Lilly and Company

NCI = National Cancer Institute

Fecha de la última revisión: 2021 M03 29


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