Kisqali tablets film-coated

Land: Armenia

Språk: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv ingrediens:

ribociclib(ribociclib succinate)

Tilgjengelig fra:

Novartis Pharma Produktions GmbH

ATC-kode:

L01EF02

INN (International Name):

ribociclib(ribociclib succinate)

Dosering :

200mg

Legemiddelform:

tablets film-coated

Enheter i pakken:

(21/1x21/) in blister, (63/3x21/) in blister

Resept typen:

Prescription

Autorisasjon status:

Registered

Autorisasjon dato:

2021-12-07

Informasjon til brukeren

This medicinal product is subject to additional monitoring. This will
allow quick identification of new
safety information. Healthcare professionals are asked to report any
suspected adverse reactions.
INSTRUCTION
FOR MEDICAL USE OF THE MEDICINAL PRODUCT
KISQALI
COMPOSITION:
_ACTIVE SUBSTANCE_:
ribociclib.
Each film-coated tablet contains ribociclib succinate, equivalent to
200 mg ribociclib.
_EXCIPIENTS_:
_ _
_core: _
microcrystalline cellulose, crospovidone type A, low-substituted
hydroxypropylcellulose,
magnesium stearate, colloidal anhydrous silica.
_composition of coating: _
iron oxide black (E172), iron oxide red (E172), soya lecithin (E322),
polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide
(E171), xanthan gum.
PHARMACEUTICAL FORM:
film-coated tablet.
PHARMACOTHERAPEUTIC GROUP.
Pharmacotherapeutic group: Antineoplastic agents, cyclin-dependent
kinase (CDK) inhibitors.
ATC code: L01EF02
CLINICAL PARTICULARS._ _
_INDICATIONS. _
Kisqali 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 luteinising
hormone-releasing hormone (LHRH) agonist.
CONTRAINDICATIONS.
Hypersensitivity to the active substance or to peanut, soya or any of
the excipients.
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

Preparatomtale

This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE 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.
3.
PHARMACEUTICAL FORMS
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 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 luteinising
hormone-releasing hormone (LHRH) agonist.
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
aromatase inhibitor or with
500 mg fulvestrant.
When Kisqali is used in combination with an aromatase inhibitor, the
aromatase inhibitor should
be taken orally once daily continuously throughout the 28-day cycle.
When Kisqali is