FDA label
What is Verzenio used for?
Verzenio contains abemaciclib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Verzenio lists 2 uses: Early Breast Cancer; Advanced or Metastatic Breast Cancer.
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Verzenio, tablet
Indications and Usage, quoted from the label by Eli Lilly and Company (NDA208716). Cross-references to other label sections are left out.
Early Breast Cancer
VERZENIO® (abemaciclib) is indicated:
- in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.
Advanced or Metastatic Breast Cancer
VERZENIO (abemaciclib) is indicated:
- in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer.
- in combination with fulvestrant for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
- in combination with imlunestrant for the treatment of adults with estrogen receptor (ER)-positive, HER2-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA authorized test, with disease progression following at least one line of endocrine therapy.
- as monotherapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Source: DailyMed label, set id be4bc0de-0fdc-4d46-8d25-be43c79e6a06, version 31, effective September 18, 2026. NDC 0002-4483, one of 4 listings for this product.
Questions
What is Verzenio used for?
The FDA label for Verzenio lists 2 uses: Early Breast Cancer; Advanced or Metastatic Breast Cancer.
What drug class is Verzenio?
FDA lists abemaciclib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.