Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Regorafenib monohydrate 41.49mg equivalent to regorafenib 40 mg
Bayer New Zealand Limited
Regorafenib monohydrate 41.49 mg (equivalent to regorafenib 40 mg)
40 mg
Tablet
Active: Regorafenib monohydrate 41.49mg equivalent to regorafenib 40 mg Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry pink 85G35294 Povidone
Prescription
Bayer AG
Stivarga is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy.
Package - Contents - Shelf Life: Bottle, plastic, HDPE white opaque with a child resistant screw cap PP white with sealing insert and desiccant - 28 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture 7 weeks opened stored at or below 25°C protect from moisture - Bottle, plastic, HDPE white opaque with a child resistant screw cap PP white with sealing insert and desiccant - 84 tablets - 36 months from date of manufacture stored at or below 25°C protect from moisture 7 weeks opened stored at or below 25°C protect from moisture
2013-12-12
170927 Stivarga CMI 1 STIVARGA ® Sti-VAR-gah _regorafenib _ CONSUMER MEDICINE INFORMATION 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. STIVARGA is a prescription medicine. It should only be used under medical supervision. 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 used to treat: • Colon, rectal or bowel cancer that has spread to other parts of the body in adult patients who have received other treatments or cannot be treated with other regimens; • Gastrointestinal stromal tumours (GIST) in adult patients who have been previously treated with other anticancer medicines (imatinib and sunitinib). 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 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 TAKE _ _IT _ DO NOT TAKE STIVARGA IF YOU HAVE AN ALLERGY TO: • regorafenib, the active ingredient in STIVARGA • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT TAKE THIS MEDICINE IF YOU ARE PREGNANT OR THINK YOU MIGHT BE PREGNANT. DO NOT Izlasiet visu dokumentu
1801 Stivarga dDS Page 1 of 26 DATA SHEET 1. STIVARGA ® (REGORAFENIB) Stivarga 40 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Regorafenib 40 mg Each daily dose of 160 mg contains 2.427 mmol (or 55.8 mg) of sodium. To be taken into consideration by patients on a controlled sodium diet. Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Light pink film-coated tablets, oval shaped with a length of 16 mm and a width of 7 mm 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 adult patients with: • metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy (see section 5.1.3). • unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib. 4.2 DOSE AND METHOD OF ADMINISTRATION 4.2.1 DOSE Stivarga should be prescribed by doctors experienced in the administration of anticancer therapy. The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy. This 4-week period is considered a treatment cycle. If a dose is missed, then it should be taken on the same day as soon as the patient remembers. The patient should not take two doses on the same day to make up for a missed dose. In case of vomiting after regorafenib administration, the patient should not take additional tablets. 1801 Stivarga dDS Page 2 of 26 Treatment should continue as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4). Patients with performance status (PS) 2 or higher were excluded from clinical studies. There is limited data in patients with PS ≥2. 4.2.1.1 DOSE ADJUST Izlasiet visu dokumentu