국가: 뉴질랜드
언어: 영어
출처: Medsafe (Medicines Safety Authority)
Entrectinib 200mg;
Roche Products (NZ) Ltd
200 mg
Capsule
Active: Entrectinib 200mg Excipient: Colloidal silicon dioxide Crospovidone Hypromellose Lactose Magnesium stearate Microcrystalline cellulose Sunset yellow aluminium lake Tartaric acid TekPrint blue SB-6018 Titanium dioxide
Prescription
Solid tumours Rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive locally advanced or metastatic solid tumours, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. This indication was approved based on objective response rate and response duration in single-arm trials. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials. Non-small cell lung cancer (NSCLC) Rozlytrek is indicated for the treatment of adult patients with ROS1-positive, locally advanced or metastatic NSCLC.
Package - Contents - Shelf Life: Bottle, HDPE with PP/PE CRC screw cap with integrated desiccant - 90 capsules - 48 months from date of manufacture stored at or below 30°C
2019-05-31
rocrozly10623 1 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 ca 전체 문서 읽기
Rozlytrek 20230613 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Rozlytrek (entrectinib) 100 mg and 200 mg hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mg hard capsule contains 100 mg entrectinib. Each 200 mg hard capsule contains 200 mg entrectinib. Excipients with known effect Each 100 mg hard capsule contains 65 mg lactose. Each 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 hard capsules are yellow with “ENT 100” imprinted in blue on the body. Rozlytrek 200 mg hard capsules are orange with “ENT 200” imprinted in blue on the body. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SOLID TUMOURS Rozlytrek is indicated for the treatment of adult and paediatric patients 12 years of age and older, with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive locally advanced or metastatic solid tumours, who have progressed following prior therapies, or as initial therapy when there are no acceptable standard therapies. This indication was approved based on objective response rate and response duration in single- arm trials. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials. NON-SMALL CELL LUNG CANCER (NSCLC) Rozlytrek is indicated for the treatment of adult patients with ROS1-positive, locally advanced or metastatic NSCLC. 4.2 DOSE AND METHOD OF ADMINISTRATION GENERAL Patient selection _Solid tumours _ A validated assay is required for the selection of patients with NTRK fusion-positive locally advanced or metastatic solid tumours. NTRK fusion-positive status should be established prior to initiation of Rozlytrek therapy. Rozlytrek 20230613 2 _NSCLC _ A validated assay is required for the selection of patients with ROS1-positive locally advanced or metastatic NSCLC. ROS1-positive status should be established prior to initiation of Rozlytrek therapy. DOSE Adult patients The recommended do 전체 문서 읽기