Brand Name
Verzenio
Generic Name
Abemaciclib
View Brand Information FDA approval date: September 28, 2017
Classification: Kinase Inhibitor
Form: Tablet
What is Verzenio (Abemaciclib)?
VERZENIO ® is a kinase inhibitor indicated: in combination with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor -positive, human epidermal growth factor receptor 2 -negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20% as determined by an FDA approved test.
Approved To Treat
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Brand Information
Verzenio (abemaciclib)
1DOSAGE FORMS AND STRENGTHS
50 mg tablets: oval beige tablet with “Lilly” debossed on one side and “50” on the other side.
100 mg tablets: oval white to practically white tablet with “Lilly” debossed on one side and “100” on the other side.
150 mg tablets: oval yellow tablet with “Lilly” debossed on one side and “150” on the other side.
200 mg tablets: oval beige tablet with “Lilly” debossed on one side and “200” on the other side.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Diarrhea
- Neutropenia
- Interstitial Lung Disease (ILD) or Pneumonitis
- Hepatotoxicity
- Venous Thromboembolism
3.1Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety population described in the Warnings and Precautions reflect exposure to VERZENIO in 3691 patients from four clinical trials: monarchE, MONARCH 1, MONARCH 2, and MONARCH 3. The safety population includes exposure to VERZENIO as a single agent at 200 mg twice daily in 132 patients in MONARCH 1 and to VERZENIO at 150 mg twice daily in 3559 patients administered in combination with fulvestrant, tamoxifen, or an aromatase inhibitor in monarchE, MONARCH 2, and MONARCH 3. The median duration of exposure ranged from 4.5 months in MONARCH 1 to 24 months in monarchE. The most common adverse reactions (incidence ≥20%) across clinical trials were: diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of VERZENIO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Respiratory disorders: Interstitial lung disease (ILD)/pneumonitis [see Warnings and Precautions (.
4DESCRIPTION
Abemaciclib is a kinase inhibitor for oral administration. It is a white to yellow powder with the empirical formula C
The chemical name for abemaciclib is 2-Pyrimidinamine,
VERZENIO (abemaciclib) tablets are provided as immediate-release oval white, beige, or yellow tablets. Inactive ingredients are as follows: Excipients—microcrystalline cellulose 102, microcrystalline cellulose 101, lactose monohydrate, croscarmellose sodium, sodium stearyl fumarate, silicon dioxide. Color mixture ingredients—polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red.
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Diarrhea
VERZENIO may cause diarrhea, which may be severe in some cases
- Early identification and intervention is critical for the optimal management of diarrhea. Instruct patients that at the first sign of loose stools, they should start antidiarrheal therapy (for example, loperamide) and notify their healthcare provider for further instructions and appropriate follow up.
- Encourage patients to increase oral fluids.
- If diarrhea does not resolve with antidiarrheal therapy within 24 hours to ≤Grade 1, suspend VERZENIO dosing
Neutropenia
Advise patients of the possibility of developing neutropenia and to immediately contact their healthcare provider should they develop a fever, particularly in association with any signs of infection
Interstitial Lung Disease/Pneumonitis
Advise patients to immediately report new or worsening respiratory symptoms
Hepatotoxicity
Inform patients of the signs and symptoms of hepatotoxicity. Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatotoxicity
Venous Thromboembolism
Advise patients to immediately report any signs or symptoms of thromboembolism such as pain or swelling in an extremity, shortness of breath, chest pain, tachypnea, and tachycardia
Embryo-Fetal Toxicity
- Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy
- Advise females of reproductive potential to use effective contraception during VERZENIO treatment and for 3 weeks after the last dose
Lactation
Advise lactating women not to breastfeed during VERZENIO treatment and for at least 3 weeks after the last dose
Infertility
Inform males of reproductive potential that VERZENIO may impair fertility
Drug Interactions
- Inform patients to avoid concomitant use of ketoconazole. Dose reduction may be required for other strong CYP3A inhibitors or for moderate CYP3A inhibitors
- Grapefruit may interact with VERZENIO. Advise patients not to consume grapefruit products while on treatment with VERZENIO.
- Advise patients to avoid concomitant use of strong and moderate CYP3A inducers and to consider alternative agents
- Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products
Dosing
- Instruct patients to take the doses of VERZENIO at approximately the same times every day and to swallow whole (do not chew, crush, or split them prior to swallowing)
- If patient vomits or misses a dose, advise the patient to take the next prescribed dose at the usual time
- Advise the patient that VERZENIO may be taken with or without food
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA
Copyright © 2017, 2025, Eli Lilly and Company. All rights reserved.
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