Eli Lilly Verzenio (Abemaciclib) Monograph

Published: October 31, 2025

Clinicians should leverage healthcare awareness months, particularly ones when advanced screening is critical to patient outcomes, to emphasize the critical importance of early screenings, enhance patients' awareness and understanding of the particular health concern, and stay informed of the latest therapies as they achieve approval or expanded approval from the U.S. Food and Drug Administration (FDA).

During Breast Cancer Awareness Month, we are highlighting a therapy with multiple FDA approvals for the treatment of breast cancer.

Verzenio (abemaciclib) is a breast cancer therapy option that initially received FDA approval in 2017. Verzenio is a kinase inhibitor that comes in 50 mg, 100 mg, 150 mg, and 200 mg tablets.

Read on to learn more about Verzenio.

Medication Overview:

Brand Name: Verzenio
Generic Name: Abemaciclib
Treatment for: Breast cancer
Manufacturer(s): Eli Lilly
Initial FDA Approval: 2017

Verzenio Indications Rundown

Indicated Condition	Indication	Age	FDA Approved
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence	In combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.	Adults	2021
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer	In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.	Adults	2018
Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy	In combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.	Adults	2017
HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting	As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.	Adults	2017

Warnings and Precautions:

Diarrhea: Verzenio can cause severe cases of diarrhea, associated with dehydration and infection. Instruct patients at the first sign of loose stools to initiate antidiarrheal therapy, increase oral fluids, and notify their healthcare provider.
Neutropenia: Monitor complete blood counts prior to the start of Verzenio therapy, every 2 weeks for the first 2 months, monthly for the next 2 months, and as clinically indicated.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe and fatal cases of ILD/pneumonitis have been reported. Monitor for clinical symptoms or radiological changes indicative of ILD/pneumonitis. Permanently discontinue Verzenio in all patients with Grade 3 or 4 ILD or pneumonitis.
Hepatotoxicity: Increases in serum transaminase levels have been observed. Perform liver function tests (LFTs) before initiating treatment with VERZENIO. Monitor LFTs every two weeks for the first two months, monthly for the next 2 months, and as clinically indicated.
Venous Thromboembolism: Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate.
Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

Dosage and Administration:

Verzenio tablets are taken orally with or without food.
Recommended starting dose in combination with fulvestrant, tamoxifen, or an aromatase inhibitor: 150 mg twice daily.
Recommended starting dose as monotherapy: 200 mg twice daily.
Dosing interruption and/or dose reductions may be required based on individual safety and tolerability.

Contraindications:

None.

Drug Interactions:

CYP3A Inhibitors: Avoid concomitant use of ketoconazole. Reduce the VERZENIO dose with concomitant use of other strong and moderate CYP3A inhibitors.
CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers.

Adverse Reactions:

Most common adverse reactions (incidence ≥20%) were diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia.

Examples of Abemaciclib in Guidelines

Early and Locally Advanced Breast Cancer: Diagnosis and Management

National Institute for Health and Care Excellence (NICE), April 2025
“Abemaciclib with endocrine therapy is recommended as an option in NICE technology appraisal guidance for adjuvant treatment of hormone receptor-positive, HER2-negative, node-positive early breast cancer at high risk of recurrence.”

Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

American Society of Clinical Oncology (ASCO), May 2024
“Abemaciclib for 2 years plus ET for ≥ 5 years may be offered to patients meeting the criteria of the ITT monarchE population with resected, hormone receptor-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence, defined as having ≥4 positive axillary lymph nodes (ALNs) or as having 1-3 positive ALNs plus at least one of the following features: grade 3 disease, tumor size ≥5 cm, or Ki-67 index ≥20%.”

Please note: This article is current as of October 29, 2025. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.