KISQALI FILM-COATED TABLET 200MG

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Ribociclib Succinate 254.4mg eqv Ribociclib

Tilgjengelig fra:

NOVARTIS (SINGAPORE) PTE LTD

ATC-kode:

L01EF02

Legemiddelform:

TABLET, FILM COATED

Sammensetning:

Ribociclib Succinate 254.4mg eqv Ribociclib 200mg

Administreringsrute:

ORAL

Resept typen:

Prescription Only

Produsert av:

NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD.

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2018-01-22

Informasjon til brukeren

Kisqali May 2022.SIN
Page 1 of 53
KISQALI
®
KISQALI
®
200 mg film-coated tablets
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
FILM-COATED TABLET 200 MG
Light greyish violet, unscored, round, curved with beveled edges,
debossed with “RIC” on one
side and “NVR” on the other side.
ACTIVE SUBSTANCE
Each tablet containing 200 mg of ribociclib, as the succinate salt.
EXCIPIENTS
Tablet core: Microcrystalline cellulose; low-substituted
hydroxypropylcellulose; crospovidone
(Type A); colloidal silicon dioxide; magnesium stearate.
Coating material: Polyvinyl alcohol (partially hydrolysed); titanium
dioxide (E171); iron oxide
black (E172); iron oxide red (E172); talc: lecithin (soy) (E322);
xanthan gum.
INDICATIONS
Kisqali is indicated in combination with an aromatase inhibitor as
initial endocrine-based therapy
for the treatment of pre/perimenopausal or postmenopausal women with
hormone receptor (HR)-
positive, human epidermal growth factor receptor 2 (HER2)-negative
advanced or metastatic
breast cancer.
Kisqali is also indicated in combination with fulvestrant for the
treatment of postmenopausal
women with HR-positive, HER2-negative advanced or metastatic breast
cancer, as initial
endocrine-based therapy or following disease progression on endocrine
therapy.
DOSAGE REGIMEN AND ADMINISTRATION
Treatment with Kisqali
®
should be initiated by a physician experienced in the use of
anticancer
therapies.
DOSAGE REGIMEN
GENERAL TARGET POPULATION
The recommended dose of Kisqali is 600 mg (3 x 200 mg film-coated
tablets) taken orally, once
daily for 21 consecutive days followed by 7 days off treatment
resulting in a complete cycle of 28
days. Kisqali can be taken with or without food (see section
Interactions).
When co-administered with Kisqali, refer to the full prescribing
information for the recommended
dose of the aromatase inhibitor to be used.
Kisqali May 2022.SIN
Page 2 of 53
Patients should take their dose of Kisqali and aromatase inhibitor at
approximately the same time
each day, preferably in the morning.
Whe

Preparatomtale

Kisqali May 2022.SINv2
Page 1 of 55
KISQALI
®
KISQALI
®
200 mg film-coated tablets
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
FILM-COATED TABLET 200 MG
Light greyish violet, unscored, round, curved with beveled edges,
debossed with “RIC” on one
side and “NVR” on the other side.
ACTIVE SUBSTANCE
Each tablet containing 200 mg of ribociclib, as the succinate salt.
EXCIPIENTS
Tablet core: Microcrystalline cellulose; low-substituted
hydroxypropylcellulose; crospovidone
(Type A); colloidal silicon dioxide; magnesium stearate.
Coating material: Polyvinyl alcohol (partially hydrolysed); titanium
dioxide (E171); iron oxide
black (E172); iron oxide red (E172); talc: lecithin (soy) (E322);
xanthan gum.
INDICATIONS
Kisqali is indicated for the treatment of adult patients with hormone
receptor (HR)-positive,
human epidermal growth factor receptor 2 (HER2)-negative advanced or
metastatic breast cancer
in combination with:
• an aromatase inhibitor as initial endocrine-based therapy in
pre/perimenopausal or
postmenopausal women or in men; or
• fulvestrant as initial endocrine-based therapy or following
disease progression on endocrine
therapy in postmenopausal women or in men.
DOSAGE REGIMEN AND ADMINISTRATION
Treatment with Kisqali
®
should be initiated by a physician experienced in the use of
anticancer
therapies.
DOSAGE REGIMEN
GENERAL TARGET POPULATION
The recommended dose of Kisqali is 600 mg (3 x 200 mg film-coated
tablets) taken orally, once
daily for 21 consecutive days followed by 7 days off treatment
resulting in a complete cycle of 28
days. Kisqali can be taken with or without food (see section
Interactions).
When co-administered with Kisqali, refer to the full prescribing
information for the recommended
dose of the aromatase inhibitor to be used.
Kisqali May 2022.SINv2
Page 2 of 55
Patients should take their dose of Kisqali and aromatase inhibitor at
approximately the same time
each day, preferably in the morning.
When co-administered with Kisqali, the recommended dose of fulvestrant
is 500mg admi