KISQALI 200 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

RIBOCICLIB AS SUCCINATE

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

L01XE42

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

RIBOCICLIB AS SUCCINATE 200 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD, SINGAPORE

المجال العلاجي:

RIBOCICLIB

الخصائص العلاجية:

Kisqali is indicated in combination with:* a non-steroid aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, as initial endocrine-based therapy.or* fulvestrant for the treatment of men and postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

تاريخ الترخيص:

2023-06-30

نشرة المعلومات

DOR-Kis-PIL-0223-09
KIS APL JAN23 V6
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986
The medicine is dispensed with a doctor’s prescription only
KISQALI
® 200 MG
FILM-COATED TABLETS
ACTIVE INGREDIENT:
Each tablet contains: ribociclib 200 mg (as ribociclib succinate
254.40 mg)
Inactive and allergenic ingredients: see section 2 under “Important
information about some of the ingredients of the medicine” and
section 6 “Further information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It may harm them even if it seems to you
that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Kisqali is intended for the treatment in combination with:
•
A
non-steroidal
aromatase
inhibitor
in
pre/perimenopausal
or
postmenopausal women, with hormone receptor (HR)-positive,
human epidermal growth factor receptor 2 (HER2)-negative locally
advanced or metastatic breast cancer, as initial endocrine-based
therapy.
•
Fulvestrant in men and postmenopausal women with HR-positive,
HER2-negative advanced or metastatic breast cancer, as initial
endocrine-based
therapy
or
following
disease
progression
on
endocrine therapy.
THERAPEUTIC GROUP: Cyclin-dependent kinase enzyme inhibitors.
Kisqali contains the active ingredient ribociclib, which belongs to a
group of medicines called cyclin-dependent kinase (CDK) inhibitors.
Kisqali works by blocking proteins called cyclin-dependent kinases
4 and 6, which are important for the growth and division of cells.
Blocking these proteins can slow down the growth of cancer cells
and delay the progression of the cancer.
If you have questions about how Kisqali works or why it was
prescribed, ask your doctor.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
•
You are sensitive (alle

خصائص المنتج

1
KIS SPI 23OCT23 V7
EU SmPC AUG 23
1. NAME OF THE MEDICINAL PRODUCT
Kisqali 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains ribociclib succinate, equivalent to
200 mg ribociclib.
Excipients with known effect
Each film-coated tablet contains 0.344 mg soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light greyish violet, unscored, round, curved with bevelled edges
(approximate diameter: 11.1 mm),
debossed with “RIC” on one side and “NVR” on the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Kisqali is indicated in combination with:
•
a non-steroid aromatase inhibitor for the treatment of
pre/perimenopausal or postmenopausal
women, with hormone receptor (HR)-positive, human epidermal growth
factor receptor 2
(HER2)-negative locally advanced or metastatic breast cancer, as
initial endocrine-based therapy; or
•
fulvestrant for the treatment of men and postmenopausal women with
HR-positive, HER2-
negative advanced or metastatic breast cancer, as initial
endocrine-based therapy or following disease
progression on endocrine therapy.
4.2
Posology and method of administration
Treatment with Kisqali should be initiated by a physician experienced
in the use of anticancer
therapies.
Posology
The recommended dose is 600 mg (three 200 mg film-coated tablets) of
ribociclib once daily for
21 consecutive days followed by 7 days off treatment, resulting in a
complete cycle of 28 days. The
treatment should be continued as long as the patient is deriving
clinical benefit from therapy or until
unacceptable toxicity occurs.
Kisqali should be used together with 2.5 mg letrozole or another
non-steroidal aromatase inhibitor or
with 500 mg fulvestrant.
When Kisqali is used in combination with a non-steroidal aromatase
inhibitor, the non steroidal
aromatase inhibitor should be taken orally once daily continuously
throughout the 28-day cycle. Please
KIS API OCT23 V7
EU SmPC Aug 23
2
refer to the Pre