Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
cabozantinib (S)-malate, Quantity: 76.03 mg (Equivalent: cabozantinib, Qty 60 mg)
Ipsen Pty Ltd
Tablet, film coated
Excipient Ingredients: titanium dioxide; magnesium stearate; hypromellose; triacetin; colloidal anhydrous silica; iron oxide yellow; hyprolose; lactose; croscarmellose sodium; microcrystalline cellulose
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, oval-shaped tablets, debossed with "XL" on one side and "60" 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
CABOMETYX ® C A B O M E T Y X ® 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 USING CABOMETYX? CABOMETYX contains the active ingredient cabozantinib. CABOMETYX is used to treat patients with advanced kidney cancer (advanced renal cell carcinoma), liver cancer, or a type of thyroid cancer called differentiated thyroid cancer. For more information, see Section 1. Why am I using CABOMETYX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CABOMETYX? Do not use if you have ever had an allergic reaction to cabozantinib or any of the ingredients listed at the end of the CMI. 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 use CABOMETYX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with CABOMETYX 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 USE CABOMETYX? • The usual dose is 60 mg taken once a day. Your doctor will decide on the right dose for you. • CABOMETYX should not be taken with food. Grapefruit juice should be avoided while using this medicine. More instructions can be found in Section 4. How do I use CABOMETYX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CABOMETYX? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using CABOMETYX. • Tell your doctor immediately if you become pregnant. THINGS YOU SHOULD NOT DO • Do not stop using this medicine suddenly. • Do not take CABOMETYX to treat any other complaints unless your doctor tells you to. • Do not give your medicine to anyone else, even if they have the s Belgenin tamamını okuyun
CABOMETYX Product Information V10 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 as monotherapy 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. CABOMETYX in combination with nivolumab is indicated for the first-line treatment of advanced renal cell carcinoma. ▼ CABOMETYX Product Information V10 2 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 Belgenin tamamını okuyun