Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
regorafenib, Quantity: 40 mg
Bayer Australia Ltd
Regorafenib
Tablet
Excipient Ingredients: polyvinyl alcohol; croscarmellose sodium; iron oxide red; microcrystalline cellulose; povidone; purified talc; magnesium stearate; titanium dioxide; macrogol 3350; colloidal anhydrous silica; iron oxide yellow; lecithin
Oral
28 (starter pack), 84 (3 x 28), 28
(S4) Prescription Only Medicine
STIVARGA is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine,- oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy.,STIVARGA is indicated for the treatment of patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.,STIVARGA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Visual Identification: Light pink, oval tablet embossed with '40' on one side and 'BAYER' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2013-11-29
Stivarga CMI_VX2.0 1 STIVARGA ® 40 MG TABLETS (STI·VAR·GAH) _regorafenib_ _ _ CONSUMER MEDICINE INFORMATION WARNING: Liver problems Stivarga can cause liver problems which can be serious and in rare cases lead to death. Your doctor will check your liver function before you start taking Stivarga and monitor your liver function during treatment. Your doctor may need to change your dose or advise you to stop taking Stivarga. Please see under section SIDE EFFECTS the possible signs of severe liver injury. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about STIVARGA. 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 STIVARGA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS, OR ARE UNSURE ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST FOR MORE ADVICE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT STIVARGA IS USED FOR STIVARGA is a medicine used to treat cancer by slowing down the growth and spread of cancer cells. STIVARGA cuts off the blood supply that keeps cancer cells growing. STIVARGA is used to treat: • colon, rectal or bowel cancer that has spread to other parts of the body in patients who have previously received other treatments; • gastrointestinal stromal tumour (GIST) in patients who have previously received other treatments. • liver cancer in patients who have been previously treated with another anticancer medicine (sorafenib) GIST is a cancer of the stomach and bowel. It is caused by the uncontrolled growth of cells in the wall of the stomach or bowel. STIVARGA belongs to a group of medicines called antineoplastic (anti-cancer) agents. 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. STIVARGA is not addictive. BEFORE YOU TAKE STIVARGA _WHEN YOU MUST NOT _ Прочитайте повний документ
Stivarga PI_VX1.0, CCDS 10 Page 1 of 33 AUSTRALIAN PRODUCT INFORMATION - STIVARGA ® (REGORAFENIB) 40 MG TABLETS WARNING: HEPATOTOXICITY Rare cases of fatal hepatotoxicity have been observed in clinical trials and in the post-marketing setting, including in the absence of hepatic metastases. Monitor hepatic function prior to and during treatment [see section 4.4 Special warnings and precautions for use - Hepatotoxicity]. Modify or interrupt dose if signs of liver injury emerge, depending upon severity and persistence [See section 4.2 Dose and method of administration, Table 1] 1 NAME OF THE MEDICINE Regorafenib 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg regorafenib (as 41.49 mg regorafenib monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Light pink, oval tablets, marked with ‘BAYER’ on one side and ‘40’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS STIVARGA is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild type, an anti-EGFR therapy. STIVARGA is indicated for the treatment of patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib. STIVARGA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 4.2 DOSE AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION For oral use. DOSAGE REGIMEN Take four STIVARGA (40 mg) tablets daily at the same time each day for three weeks on therapy (21 days) followed by one week off therapy (7 days) to comprise a cycle of four weeks (28 days) (see section 5.2 Pharmacokinetic properties – Absorption)_. _The tablets should be swallowed whole with water after a low-fat meal (ideally at breakfast) that contains Прочитайте повний документ