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HIGHLIGHTS OF PRESCRIBING INFORMATION …

HIGHLIGHTS OF PRESCRIBING INFORMATION These HIGHLIGHTS do not include all the INFORMATION needed to use NEXAVAR safely and effectively. See full PRESCRIBING INFORMATION for NEXAVAR. NEXAVAR (sorafenib) tablets, oral Initial Approval: 2005 --------------------------- INDICATIONS AND USAGE ---------------------------- NEXAVAR is a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma ( ) Advanced renal cell carcinoma ( ) Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment ( ) ----------------------- DOSAGE AND ADMINISTRATION ----------------------- 400 mg (2 tablets) orally twice daily without food. ( ) Treatment interruption and/or dose reduction may be needed to manage suspected adverse drug reactions. ( ) --------------------- DOSAGE FORMS AND STRENGTHS ---------------------- 200 mg Tablets (3) ------------------------------ CONTRAINDICATIONS ------------------------------ NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of NEXAVAR.

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NEXAVAR safely and effectively. See full prescribing information for NEXAVAR.

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