KISQALI ribociclib 200 mg (as succinate) film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ribociclib succinate, Quantity: 254.4 mg (Equivalent: ribociclib, Qty 200 mg)

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; hyprolose; crospovidone; titanium dioxide; purified talc; xanthan gum; polyvinyl alcohol; lecithin; iron oxide black; iron oxide red

Administration route:

Oral

Units in package:

42 tablets, 63 tablets, 21 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

KISQALI is indicated for the treatment of 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 or fulvestrant, as initial endocrine-based therapy or following prior endocrine therapy.

Product summary:

Visual Identification: Light greyish violet, round, curved, unscored, film-coated tablet with bevelled edges, and debossed with RIC on one side and NVR on the other; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2017-10-23

Patient Information leaflet

KISQALI
®
K
I
S
Q
A
L
I
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING KISQALI?
Kisqali contains the active ingredient ribociclib (as succinate).
Kisqali is used to treat certain types of breast cancer.
For more information, see Section 1. Why am I using Kisqali? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE KISQALI?
Do not use if you have ever had an allergic reaction to ribociclib,
cyclin dependent kinase inhibitors, soy lecithin or any of the
ingredients listed at the end of the CMI. Do not use Kisqali if you
have a QT prolongation heart problem.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Kisqali? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Kisqali and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE KISQALI?
•
Kisqali is taken in repeating cycles of 28 days, each day for 21 days
followed by a 7 day treatment break. Kisqali is used in
combination with a second medicine (either an aromatase inhibitor or
fulvestrant), which are used as hormonal anticancer
therapies.
More instructions can be found in Section 4. How do I use Kisqali? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING KISQALI?
THINGS YOU
SHOULD DO
•
REMIND ANY DOCTOR, DENTIST OR PHARMACIST YOU VISIT THAT YOU ARE USING
KISQALI.
•
KEEP ALL YOUR DOCTOR APPOINTMENTS AS REGULAR TESTS ON YOUR BLOOD,
HEART AND LUNG FUNCTION ARE
NEEDED.
THINGS YOU
SHOULD NOT DO
•
Do not take Kisqali if you are pregnant or breastfeeding.
•
Do not eat grapefruit (or grapefruit juice), pomelo, star fruit or
Seville oranges.
DRIVING
OR USING
MACHINES
•
Treatment with Kisqali may make you feel tired or dizzy.

Summary of Product characteristics

Kisqali Product Informaton
1
AUSTRALIAN PRODUCT INFORMATION - KISQALI
®
(RIBOCICLIB) TABLETS
1.
NAME OF THE MEDICINE
Ribociclib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Each film coated tablet contains ribociclib succinate equivalent to
200 mg ribociclib.
EXCIPIENTS
Excipients with known effect: each film-coated tablet contains 0.344
mg soya lecithin.
For full list of excipients see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Light greyish violet, unscored, round (approx. diameter: 11.1 mm),
curved film-coated tablet
with bevelled edges; 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 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 or fulvestrant, as initial
endocrine-based therapy or
following prior endocrine therapy.
In pre- or perimenopausal women, the endocrine therapy should be
combined with a luteinising
hormone-releasing hormone (LHRH) agonist.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment with KISQALI should be initiated by a physician experienced
in the use of anticancer
therapies.
Monitoring for adverse drug reactions (ADRs) is required, including
full blood counts, LFTs,
serum electrolytes, and ECG; dose modification (delay, reduction) or
cessation may be required
(see Tables 1-5).
DOSE
KISQALI
The recommended dose of KISQALI is 600 mg (three 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 may be taken with or without food (see
section 4.5 Interactions with
other medicines and other forms of interaction). Treatment should be
continued as long as the
patient is deriving clinical benefit from therapy or until
unacceptable toxicity occurs.
Kisqali Product Informaton
2
Aromatase inhibitor
When co-administered with