Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
abemaciclib
Eli Lilly Nederland B.V.
L01EF03
abemaciclib
Antineoplastic agents
Breast Neoplasms
Early Breast CancerVerzenios 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 CancerVerzenios 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.
Revision: 10
Authorised
2018-09-26
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VERZENIOS 50 MG FILM-COATED TABLETS VERZENIOS 100 MG FILM-COATED TABLETS VERZENIOS 150 MG FILM-COATED TABLETS abemaciclib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Verzenios is and what it is used for 2. What you need to know before you take Verzenios 3. How to take Verzenios 4. Possible side effects 5. How to store Verzenios 6. Contents of the pack and other information 1. WHAT VERZENIOS IS AND WHAT IT IS USED FOR Verzenios is a cancer medicine containing the active substance abemaciclib. Abemaciclib blocks the effects of proteins called cyclin-dependent kinase 4 and 6. These proteins are abnormally active in some cancer cells and make them grow out of control. Blocking the action of these proteins can slow down growth of cancer cells, shrink the tumour and delay progression of the cancer. Verzenios is used to treat certain types of breast cancer (hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-)) which have: - spread to the lymph nodes of the armpit, with no detectable spread to other parts of the body, been surgically removed, and have certain characteristics that increase the risk of the cancer returning. Treatment is given in combination with hormonal therapy, such as aromatase inhibitors or tamoxifen, to prevent the cancer from coming back after surgery (treatment after surgery is called adjuvant therapy) - spread beyond the original tumour and/or to other orga Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Verzenios 50 mg film-coated tablets Verzenios 100 mg film-coated tablets Verzenios 150 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Verzenios 50 mg film-coated tablets Each film-coated tablet contains 50 mg abemaciclib. _Excipients with known effect _ Each film-coated tablet contains 14 mg of lactose monohydrate. Verzenios 100 mg film-coated tablets Each film-coated tablet contains 100 mg abemaciclib. _Excipients with known effect _ Each film-coated tablet contains 28 mg of lactose monohydrate. Verzenios 150 mg film-coated tablets Each film-coated tablet contains 150 mg abemaciclib. _Excipients with known effect _ Each film-coated tablet contains 42 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Verzenios 50 mg film-coated tablets Beige, oval tablet of 5.2 x 9.5 mm, debossed with “Lilly” on one side and “50” on the other. Verzenios 100 mg film-coated tablets White, oval tablet of 6.6 x 12.0 mm, debossed with “Lilly” on one side and “100” on the other. Verzenios 150 mg film-coated tablets Yellow, oval tablet of 7.5 x 13.7 mm, debossed with “Lilly” on one side and “150” on the other. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 combin Aqra d-dokument sħiħ