Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
cabozantinib (S)-malate, Quantity: 50.69 mg (Equivalent: cabozantinib, Qty 40 mg)
Ipsen Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose; microcrystalline cellulose; hypromellose; croscarmellose sodium; iron oxide yellow; hyprolose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; triacetin
Oral
30
(S4) Prescription Only Medicine
Renal Cell Carcinoma (RCC),CABOMETYX is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC):,- in treatment-na?ve adults with intermediate or poor risk,- in adults following prior treatment with vascular endothelial growth factor targeted therapy.,CABOMETYX in combination with nivolumab is indicated for the first-line treatment of advanced renal cell carcinoma.,Hepatocellular Carcinoma (HCC),CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.,Differentiated Thyroid Carcinoma (DTC),CABOMETYX is indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that has progressed during or after prior VEGFR-targeted therapy and who are radioactive iodine (RAI) refractory or ineligible.
Visual Identification: Yellow, film-coated, triangle-shaped tablets, debossed with "XL" on one side and "40" on the other side of the tablet.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2018-01-19
This medicine is subject to additional monitoring in Australia. 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 CABOMETYX ® _20MG, 40MG AND 60 MG TABLETS_ _cabozantinib_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CABOMETYX. This leaflet 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 CABOMETYX 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 CABOMETYX IS USED FOR CABOMETYX is used to treat: • advanced stages of a type of kidney cancer called renal cell carcinoma (RCC) • Liver cancer in adults who have been previously treated with a specific anticancer medicine (sorafenib) It contains the active ingredient cabozantinib (S)-malate. It is a multi-kinase inhibitor. It works by blocking the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them. These proteins can be present in high amounts in cancer cells, and by blocking their action CABOMETYX can slow down the rate at which the tumour grows and help to cut off the blood supply that the cancer needs. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE CABOMETYX _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE CABOMETYX IF YOU HAVE AN ALLERGY TO: • cabozantinib, the active ingredient in CABOMETYX • any of the other ingredients listed at the end of this leafle Prečítajte si celý dokument
CABOMETYX Product Information V6 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 CABOMETYX ® CABOZANTINIB (AS (S)-MALATE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE cabozantinib (S)-malate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CABOMETYX tablets contain cabozantinib _(S)_ -malate equivalent to either 20 mg, 40 mg or 60 mg of cabozantinib as the active ingredient. Each film-coated tablet contains either: 15.54 mg lactose (20 mg tablet), 31.07 mg lactose (40 mg tablet) or 46.61 mg lactose (60 mg tablet) For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM CABOMETYX 20 mg film-coated tablets are yellow, round with no score, and debossed with “XL” on one side and “20” on the other side of the tablet. CABOMETYX 40 mg film-coated tablets are yellow triangle shaped with no score, and debossed with “XL” on one side and “40” on the other side of the tablet. CABOMETYX 60 mg film-coated tablets are yellow oval shaped with no score, and debossed with “XL” on one side and “60” on the other side of the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RENAL CELL CARCINOMA (RCC) CABOMETYX is indicated for the treatment of advanced renal cell carcinoma (RCC): - in treatment-naïve adults with intermediate or poor risk - in adults following prior treatment with vascular endothelial growth factor targeted therapy. HEPATOCELLULAR CARCINOMA (HCC) CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib. 4.2 DOSE AND METHOD OF ADMINISTRATION ▼ CABOMETYX Product Information V6 2 Therapy with CABOMETYX should be initiated by a physician experienced in the administration of anticancer medicinal products. For RCC and HCC, the recommended Prečítajte si celý dokument