Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
entrectinib, Quantity: 200 mg
Roche Products Pty Ltd
Capsule, hard
Excipient Ingredients: propylene glycol; indigo carmine aluminium lake; magnesium stearate; hypromellose; lactose; Shellac; sunset yellow FCF; tartaric acid; colloidal anhydrous silica; microcrystalline cellulose; crospovidone; titanium dioxide; strong ammonia solution
Oral
90
(S4) Prescription Only Medicine
Non-small cell lung cancer (NSCLC),Rozlytrek is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours are ROS1-positive. Solid tumours,Rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that:,? have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,,? are metastatic or where surgical resection is likely to result in severe morbidity, and,? have either progressed following treatment or have no satisfactory alternative therapy.,This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.
Visual Identification: Size 0 hard capsules with orange body and cap with 'ENT 200' imprinted in blue on the body.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered (with Provisional Indication/s)
2020-05-15
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/ reporting-problems . ROZLYTREK ® _entrectinib_ CONSUMER MEDICINE INFORMATION THIS MEDICINE HAS PROVISIONAL APPROVAL IN AUSTRALIA FOR NTRK FUSION-POSITIVE CANCER. THE DECISION TO APPROVE THIS MEDICINE HAS BEEN MADE ON THE BASIS OF PROMISING RESULTS FROM PRELIMINARY STUDIES. MORE EVIDENCE IS REQUIRED TO BE SUBMITTED WHEN AVAILABLE TO FULLY CONFIRM THE BENEFIT AND SAFETY OF THE MEDICINE FOR THIS USE. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Rozlytrek. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Rozlytrek against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ROZLYTREK IS USED FOR Rozlytrek is used to treat adults with a type of lung cancer called non- small cell lung cancer. It is used if your cancer: • is 'ROS1-positive' – this means your cancer cells have an alteration in a gene called ROS1 and • is advanced or has spread to another part of your body (metastatic) Rozlytrek is also used to treat children (12 years and older), adolescents and adults with cancer that is ‘NTRK fusion-positive’. This means that your cancer cells have an alteration in one of the NTRK genes. Rozlytrek is used when the cancer is advanced or has spread to another part of your body (metastatic) and other treatments have not worked or are not suitable for you. Rozlytrek contains the active ingredient entrectinib. Rozlytrek belongs to a group of medicines called anti-neoplastic (or anti-cancer) agents which are used to treat cancer. Rozlytrek wor read_full_document
Rozlytrek 20220325 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 ROZLYTREK TM (ENTRECTINIB) 1. NAME OF THE MEDICINE entrectinib 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg hard capsule contains 100 mg entrectinib. Each 200 mg hard capsule contains 200 mg entrectinib. Entrectinib has the molecular formula C 31 H 34 F 2 N 6 O 2 . The molecular weight is 560.6. The chemical name is N-{5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl}-4-(4-methylpiperazin- 1-yl)-2-[(oxan-4-yl)amino]benzamide. The solubility in aqueous media decreases over the range pH 1.2 to pH 8.0. Excipients with known effect Each 100 mg hard capsule contains 65 mg lactose. E ach 200 mg hard capsule contains 130 mg lactose. For the full list of excipients, see section 6.1 _List of excipients_ . 3. PHARMACEUTICAL FORM Hard capsule. Rozlytrek 100 mg are size 2 hard capsules with yellow body and cap with “ENT 100” imprinted in blue on the body. Rozlytrek 200 mg are size 0 hard capsules with orange body and cap with “ENT 200” imprinted in blue on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NON-SMALL CELL LUNG CANCER (NSCLC) Rozlytrek is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours are ROS1-positive. SOLID TUMOURS Rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that: • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, • are metastatic or where surgical resection is likely to result in severe morbidity, and • have either progressed following treatment or have no satisfactory alternative therapy. ▼ Rozlytrek 20220325 2 This indication was approved via the PROVISIONAL APPROVAL pathway, read_full_document