Verzenios

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

abemaciclib

Dostupné z:

Eli Lilly Nederland B.V.

ATC kód:

L01EF03

INN (Medzinárodný Name):

abemaciclib

Terapeutické skupiny:

Antineoplastic agents

Terapeutické oblasti:

Breast Neoplasms

Terapeutické indikácie:

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.

Prehľad produktov:

Revision: 10

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2018-09-26

Príbalový leták

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

Súhrn charakteristických

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