Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
asciminib hydrochloride, Quantity: 43.24 mg (Equivalent: asciminib, Qty 40 mg)
Novartis Pharmaceuticals Australia Pty Ltd
Tablet, film coated
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
Oral
20 tablets, 60 tablets
(S4) Prescription Only Medicine
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.
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
Registered
2022-07-15
SCEMBLIX ® S c e m b l i x ® s c e 1 4 0 7 2 2 c 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 Lesen Sie das vollständige Dokument
Page 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 ▼ Page 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 Lesen Sie das vollständige Dokument