Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
regorafenib
Bayer Pharma AG
L01EX05
regorafenib
Antineoplastic agents, Protein kinase inhibitors
Colorectal Neoplasms
Stivarga is indicated as monotherapy 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;unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib;hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Revision: 20
Authorised
2013-08-26
36 B. PACKAGE LEAFLET 37 PACKAGE LEAFLET: INFORMATION FOR THE USER STIVARGA 40 MG FILM-COATED TABLETS regorafenib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Stivarga is and what it is used for 2. What you need to know before you take Stivarga 3. How to take Stivarga 4. Possible side effects 5. How to store Stivarga 6. Contents of the pack and other information 1. WHAT STIVARGA IS AND WHAT IT IS USED FOR Stivarga contains the active substance regorafenib. It is a medicine used to treat cancer by slowing down the growth and spread of cancer cells and cutting off the blood supply that keeps cancer cells growing. Stivarga is used to treat: - colon or rectal cancer that has spread to other parts of the body in adult patients who have received other treatments or cannot be treated with other medicines (fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy) - gastrointestinal stromal tumours (GIST), a type of cancer of the stomach and bowel, that has spread to other parts of the body or is not amenable to surgery, in adult patients who have been previously treated with other anticancer medicines (imatinib and sunitinib) - liver cancer in adult patients who have been previously treated with another anticancer medicine (sorafenib). If you have any questions about how Stivarga works or why this medicine has been prescribed for you, please ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STIVARGA DO NOT TAKE STIVARGA - if you are allergic to regorafenib or any of Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Stivarga 40 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg of regorafenib. Excipients with known effect Each daily dose of 160 mg contains 2.438 mmol (or 56.06 mg) of sodium (see section 4.4). Each daily dose of 160 mg contains 1.68 mg of lecithin (derived from soya) (see section 4.4). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM _ _ Film-coated tablet. 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 as monotherapy 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) - unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib - hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Stivarga should be prescribed by physicians experienced in the administration of anticancer therapy. Posology 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. Treatment should continue as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4). 3 Patients with perf Pročitajte cijeli dokument