Kisqali
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
27-03-2024
Produktets egenskaber
(SPC)
27-03-2024
Offentlige vurderingsrapport
(PAR)
21-07-2020
Aktiv bestanddel:
ribociclib succinate
Tilgængelig fra:
Novartis Europharm Limited
ATC-kode:
L01XE
INN (International Name):
ribociclib
Terapeutisk gruppe:
Antineoplastic agents
Terapeutisk område:
Breast Neoplasms
Terapeutiske indikationer:
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.
Produkt oversigt:
Revision: 14
Autorisation status:
Authorised
Autorisation dato:
2017-08-22
Indlægsseddel
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 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.
3
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.
Please refer to the Summary of
Product Characteristics (SmPC) of the aromatase inhibitor for
additional details.
When Kisqali is used in combination with fulvest
Læs hele dokumentet
Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 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.
3
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.
Please refer to the Summary of
Product Characteristics (SmPC) of the aromatase inhibitor for
additional details.
When Kisqali is used in combination with fulvest
Læs hele dokumentet
