Verzenios
abemaciclib
Table of contents
Overview
Verzenios is a cancer medicine used to treat women with breast cancer that is advanced or has spread to other parts of the body (metastatic). It is also used to treat men and women with early breast cancer after surgery where the cancer has spread to the lymph nodes (node-positive) and display other features indicating a higher risk for the cancer to come back. Verzenios can only be used when the cancer cells have certain types of receptor (called hormone receptors) on their surface (HR-positive) and do not produce abnormally large quantities of another receptor called HER2 (HER2-negative).
It is used together with a hormonal medicine, such as tamoxifen, an aromatase inhibitor or fulvestrant.
In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.
Verzenios contains the active substance abemaciclib.
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List item
Verzenios : EPAR - Medicine overview (PDF/109.63 KB)
First published: 29/10/2018
Last updated: 21/04/2022
EMA/521639/2018 -
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List item
Verzenios : EPAR - Risk-management-plan summary (PDF/187.45 KB)
First published: 29/10/2018
Last updated: 21/04/2022
Authorisation details
Product details | |
---|---|
Name |
Verzenios
|
Agency product number |
EMEA/H/C/004302
|
Active substance |
abemaciclib
|
International non-proprietary name (INN) or common name |
abemaciclib
|
Therapeutic area (MeSH) |
Breast Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L01EF03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
Revision |
10
|
Date of issue of marketing authorisation valid throughout the European Union |
26/09/2018
|
Contact address |
Papendorpseweg 83 |
Product information
23/06/2023 Verzenios - EMEA/H/C/004302 - R/0025
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Early Breast Cancer
Verzenios in combination with endocrine therapy is indicated 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 (see section 5.1).
In pre or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Advanced or Metastatic Breast Cancer
Verzenios is indicated for the treatment of women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.