VERZENIO 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ABEMACICLIB

Available from:

ELI LILLY ISRAEL LTD, ISRAEL

ATC code:

L01EF03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ABEMACICLIB 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ELI LILLY AND COMPANY, USA

Therapeutic area:

ABEMACICLIB

Therapeutic indications:

VERZENIO™ (abemaciclib) is indicated:•In combination with a non-steroidal aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.•in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.•as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy in the metastatic setting and prior chemotherapy in the metastatic setting including taxane in adjuvant or metastatic setting.Verzenio should not be used in women after prior treatment with cyclin-dependent kinases 4 and 6 (CDK4 and CDK6) inhibitor..• Verzenio 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.In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

Authorization date:

2023-11-30

Patient Information leaflet

I VERZTB I 05
Page 1 of 8
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
VERZENIO 100 MG
Film-coated tablets
ACTIVE INGREDIENT AND ITS QUANTITY:
Each film-coated tablet contains:
abemaciclib 100 mg
VERZENIO 50 MG
Film-coated tablets
ACTIVE INGREDIENT AND ITS QUANTITY:
Each film-coated tablet contains:
abemaciclib 50 mg
VERZENIO 150 MG
Film-coated tablets
ACTIVE INGREDIENT AND ITS QUANTITY:
Each film-coated tablet contains:
abemaciclib 150 mg
INACTIVE INGREDIENTS AND ALLERGENS IN THE PREPARATION: see section 2
“Important information
about some of the ingredients of this medicine” and section 6
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE
. This leaflet contains concise
information about this medicine. If you have any further questions,
contact your doctor or
pharmacist
.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if it seems to you that their illness is
similar.
1. WHAT IS THIS MEDICINE INTENDED FOR?
EARLY BREAST CANCER
•
Verzenio 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.
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
•
Verzenio, in combination with a non-steroidal aromatase inhibitor, is
indicated as initial
endocrine-based therapy for the treatment of postmenopausal women with
hormone
receptor (HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative
advanced or metastatic breast cancer.
•
Verzenio, in combination with fulvestrant, is indicated for the
treatment of women with
hormone receptor (HR)-positive, human epiderm

Summary of Product characteristics

X VERZTB I 08
Page 1 of 28
VERZENIO (ABEMACICLIB) TABLETS, FOR ORAL USE
FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Verzenio 50 mg, (Abemaciclib 50 mg) film-coated tablets for oral use.
Verzenio 100 mg, (Abemaciclib 100 mg) film-coated tablets for oral
use.
Verzenio 150 mg, (Abemaciclib 150 mg) film-coated tablets for oral
use.
2.
THERAPEUTIC INDICATIONS
2.1 EARLY BREAST CANCER

Verzenio 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 Clinical Studies
(14.1)]._
In pre- or perimenopausal women, aromatase inhibitor endocrine therapy
should be combined with a luteinising
hormone-releasing hormone (LHRH) agonist.
2.2 ADVANCED OR METASTATIC BREAST CANCER
VERZENIO (abemaciclib) is indicated:

in combination with a non-steroidal aromatase inhibitor as initial
endocrine-based therapy for the treatment of
postmenopausal women with hormone receptor (HR)-positive, human
epidermal growth factor receptor 2 (HER2)-
negative advanced or metastatic breast cancer.

in combination with fulvestrant for the treatment of women with
hormone receptor (HR)-positive, human epidermal
growth factor receptor 2 (HER2)-negative advanced or metastatic breast
cancer with disease progression
following endocrine therapy.

as monotherapy for the treatment of adult patients with HR-positive,
HER2-negative advanced or metastatic
breast cancer with disease progression following endocrine therapy in
the metastatic setting and prior
chemotherapy in the metastatic setting including taxane in adjuvant or
metastatic setting.
Verzenio should not be used in women after prior treatment with
cyclin-dependent kinases 4 and 6 (CDK4 and
CDK6) inhibitor.
3.
DOSAGE AND ADMINISTRATION
3.1
RECOMMENDED DOSE AND SCHEDULE

When used in combination with fulvestrant, tamoxifen, or a
non-steroidal aromatase inhibitor, the recommended