SCEMBLIX asciminib (as hydrochloride) 40 mg film-coated tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

asciminib hydrochloride, Quantity: 43.24 mg (Equivalent: asciminib, Qty 40 mg)

Commercializzato da:

Novartis Pharmaceuticals Australia Pty Ltd

Forma farmaceutica:

Tablet, film coated

Composizione:

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

Via di somministrazione:

Oral

Confezione:

20 tablets, 60 tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

SCEMBLIX is indicated for the treatment of patients 18 years of age and above with: ? Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP) previously treated with two or more tyrosine kinase inhibitors (see section 5.1 Clinical trials). ? Ph+ CML in CP with the T315I mutation.

Dettagli prodotto:

Visual Identification: Violet white, round, biconvex, film-coated tablets with beveled edges, approximately 8.2 mm diameter, unscored, debossed with 40 on one side and Novartis logo on the other side; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2022-07-15

Foglio illustrativo

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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.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I TAKING SCEMBLIX?
Scemblix contains the active ingredient asciminib. Scemblix is used to
treat patients 18 years and over with Philadelphia
chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic
phase (CP) and patients with Ph+ CML in CP who have a
certain genetic difference (mutation) called T315I.
For more information, see Section 1. Why am I taking Scemblix? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE SCEMBLIX?
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 take
Scemblix? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Scemblix 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 TAKE SCEMBLIX?
•
The usual total daily dose of Scemblix is 80 mg (2 tablets of Scemblix
40 mg, per day). Do not take Scemblix with food.
More instructions can be found in Section 4. How do I take Scemblix?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING SCEMBLIX?
THINGS YOU SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Scemblix.
•
Have regular tests to monitor your condition
THINGS YOU SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not take Scemblix with food
DRIVING OR USING MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Scemblix
affects you.
DRINKING ALCOHOL
•
There are no known interactions between Scemblix and alcohol.
LOOKING AFTER YOUR MEDICINE
•
Store below 25�

Scheda tecnica

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1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report any
suspected adverse events at
www.tga.gov.au/reporting-problems
.
AUSTRALIAN PRODUCT INFORMATION – SCEMBLIX
® (ASCIMINIB
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Asciminib hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mg film-coated tablet contains 21.62 mg asciminib
hydrochloride, which is equivalent
to 20 mg asciminib.
Each 40 mg film-coated tablet contains 43.24 mg asciminib
hydrochloride, which is equivalent
to 40 mg asciminib.
SCEMBLIX tablets contain sugars as lactose and soyabean products.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
•
20 mg film-coated tablets: pale yellow, round, biconvex, film-coated
tablets with beveled
edges, approximately 6.2 mm diameter, unscored, debossed with
“Novartis” logo on one side
and “20” on the other side.
•
40 mg film-coated tablets: violet white, round, biconvex, film-coated
tablets with beveled
edges, approximately 8.2 mm diameter, unscored, debossed with
“Novartis” logo on one side
and “40” on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SCEMBLIX is indicated for the treatment of patients 18 years of age
and above with:
•
Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML)
in chronic
phase (CP) previously treated with two or more tyrosine kinase
inhibitors (see section
5.1 Clinical trials).
•
Ph+ CML in CP with the T315I mutation.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Treatment with SCEMBLIX should be initiated by a physician experienced
in the use of
anticancer therapies and should be continued as long as clinical
benefit is observed or until
unacceptable toxicity occurs.
DOSE REGIMEN
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2
PH+ CML-CP
The recommended total daily dose of SCEMBLIX is 80 mg.
SCEMBLIX can be taken orally either as 80 mg once daily at
approximately the same time