Sorafenib (Nexavar)

==General information==
Class/mechanism: Tyrosine kinase inhibitor that inhibits multiple kinases: RAF1, BRAF, KIT, FLT-3, RET, vascular endothelial growth factor receptors VEGFR-1, VEGFR-2, VEGFR-3, and platelet-derived growth factor receptor beta (PDGFR-B). Inhibition of these kinases disrupts angiogenesis, tumor cell signaling, and induces apoptosis.Sorafenib (Nexavar) package insert Sorafenib (Nexavar) package insert (locally hosted backup)Nexavar manufacturer's website
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, or the prescribing information. 
==Diseases for which it is established (work in progress)==
*Hepatocellular carcinoma
*Renal cell carcinoma
**Clear cell renal cell carcinoma
*Differentiated thyroid cancer
==Diseases for which it is used==
*Acute myeloid leukemia
*Gastrointestinal stromal tumor
*Non-small cell lung cancer, nonsquamous
*Osteosarcoma
*Rectal cancer
*Soft tissue sarcoma
**Desmoid tumors
*Thyroid cancer
**Medullary thyroid cancer
==Patient drug information==
*Sorafenib (Nexavar) package insert
*Sorafenib (Nexavar) patient drug information (Chemocare)Sorafenib (Nexavar) patient drug information (Chemocare)
*Sorafenib (Nexavar) patient drug information (UpToDate)Sorafenib (Nexavar) patient drug information (UpToDate)
==History of changes in FDA indication==
*2005-12-20: Approved for the treatment of patients with advanced renal cell carcinoma (RCC). (Based on TARGETRCC)
*2007-11-16: Approved for the treatment of patients with unresectable hepatocellular carcinoma (HCC). (Based on SHARP)
*2013-11-22: Approved for the treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment. (Based on DECISION)
==History of changes in EMA indication==
*2006-07-19: Initial marketing authorization as Nexavar. Nexavar is indicated for the treatment of hepatocellular carcinoma.
*2006-07-19: Initial marketing authorization as Nexavar. Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
*2014-05-23: Extension of the indication for the treatment of progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
==History of changes in Health Canada indication==
*2006-07-28: Initial notice of compliance with conditions
*2009-06-12: Conditions were met
==History of changes in PMDA indication==
*2008-01-25: Initial approval for the treatment of unresectable or metastatic renal cell carcinoma.
*2009-05-20: New additional indication for the treatment of unresectable hepatocellular carcinoma.
*2014-06-20: New additional indication for the treatment of unresectable differentiated thyroid carcinoma.
*2016-02-29: Revised indication for the treatment of unresectable thyroid cancer.
==Also known as==
*Code names: BAY-43-9006, BAY-54-9085
*Brand names: Cadsonib, Nexavar, Sorabuzz, Sorafekast, Sorafekast, Sorafenat, Soranib, Soraheet, Soratib, Soravar
==References==
Category:Drugs
Category:Oral medications
Category:BRAF inhibitors
Category:FLT3 inhibitors
Category:KIT inhibitors
Category:PDGFR inhibitors
Category:RAF1 inhibitors
Category:RET inhibitors
Category:VEGFR inhibitors
Category:Acute myeloid leukemia medications
Category:Clear cell renal cell carcinoma medications
Category:Desmoid tumor medications
Category:Gastrointestinal stromal tumor medications
Category:Hepatocellular carcinoma medications
Category:Non-small cell lung cancer, nonsquamous medications
Category:Osteosarcoma medications
Category:Rectal cancer medications
Category:Renal_cell_carcinoma medications
Category:Thyroid cancer medications
Category:Thyroid cancer, differentiated medications
Category:Thyroid cancer, medullary medications
Category:EMA approved in 2006
Category:FDA approved in 2005
Category:Health Canada approved in 2006
Category:PMDA approved in 2008