Transcription of HIGHLIGHTS OF PRESCRIBING INFORMATION These …
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HIGHLIGHTS OF PRESCRIBING INFORMATION These …
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.
7.1 Effect of Strong CYP3A4 Inducers on Sorafenib 7.2 Effect of Strong CYP3A4 Inhibitors on Sorafenib 7.3 Effect of Sorafenib on Other Drugs 7.4 Neomycin 7.5 Drugs that Increase Gastric pH 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use
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