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See full prescribing information for complete boxed ...
1 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 --------------------------- 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 RAS 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. ( ) Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib ( ) ---------------------- DOSAGE AND ADMINISTRATION ---------------------- Recommended dose: 160 mg orally, once daily for the first 21 days of each 28-day cycle.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 12/2020 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: HEPATOTOXICITY 1 INDICATIONS AND USAGE 1.1 Colorectal Cancer 1.2 Gastrointestinal Stromal Tumors 1.3 Hepatocellular Carcinoma 2 DOSAGE AND ADMINISTRATION 2.1 …
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