瑞戈非尼英文说明书(2015年版).pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use STIVARGA safely and effectively. See full prescribing information for STIVARGA. STIVARGA? (regorafenib) tablets, for oral use Initial . Approval: 2012 WARNING: HEPATOTOXICITY See full prescribing information plete boxed warning. ?Severe and sometimes fatal hepatotoxicity has been observed in clinical trials. () ?Monitor hepatic function prior to and during treatment. () ?Interrupt and then reduce or discontinue Stivarga for hepatotoxicity as manifested by elevated liver function tests or hepatocellular necrosis, depending upon severity and persistence. () -------------------------- RECENT MAJOR CHANGES --------------------------Dosage and Administration () 4/2015 --------------------------- INDICATIONS AND USAGE --------------------------Stivarga is a kinase inhibitor 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 KRAS wild type, an anti-EGFR therapy. () ?Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. () ---------------------- DOSAGE AND ADMINISTRATION ---------------------- ?mended Dose: 160 mg orally, once daily for the first 21 days of each 28-day cycle. () ?Take Stivarga with a low-fat meal. (, ) --------------------- DOSAGE FORMS AND STRENGTHS --------------------40 mg film-coated tablets (3) ------------------------------ CONTRAINDICATIONS -----------------------------None. ----------------------- WARNINGS AND PRECAUTIONS ----------------------?Hemorrhage: Permanently discontinue Stivarga for severe or life-threatening hemorrhage. () ?Dermatological toxicity: Interrupt and then reduce or discontinue Stivarga depending on severity and pe