Difference between revisions of "Sorafenib (Nexavar)"
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==General information== | ==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.<ref name="insert">[http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf Sorafenib (Nexavar) package insert]</ref><ref>[[ | + | 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.<ref name="insert">[http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf Sorafenib (Nexavar) package insert]</ref><ref>[[:File:Sorafenib.pdf | Sorafenib (Nexavar) package insert (locally hosted backup)]]</ref><ref>[http://www.nexavar.com Nexavar manufacturer's website]</ref> |
<br>Route: PO | <br>Route: PO | ||
<br>Extravasation: n/a | <br>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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | 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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref> | ||
| + | |||
| + | ==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== | ==Diseases for which it is used== | ||
*[[Acute myeloid leukemia]] | *[[Acute myeloid leukemia]] | ||
| − | *[[ | + | *[[Gastrointestinal stromal tumor]] |
| − | *[[Non-small cell lung cancer]] | + | *[[Non-small cell lung cancer, nonsquamous]] |
| − | *[[ | + | *[[Osteosarcoma]] |
| + | *[[Rectal cancer]] | ||
| + | *Soft tissue sarcoma | ||
| + | **[[Desmoid tumors]] | ||
*[[Thyroid cancer]] | *[[Thyroid cancer]] | ||
| + | **[[Medullary thyroid cancer]] | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf Sorafenib (Nexavar) package insert]<ref name="insert"></ref> | *[http://labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf Sorafenib (Nexavar) package insert]<ref name="insert"></ref> | ||
| − | *[ | + | *[https://chemocare.com/druginfo/Sorafenib.aspx Sorafenib (Nexavar) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Sorafenib.aspx Sorafenib (Nexavar) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/sorafenib-patient-drug-information Sorafenib (Nexavar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/sorafenib-patient-drug-information Sorafenib (Nexavar) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/sorafenib-patient-drug-information Sorafenib (Nexavar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/sorafenib-patient-drug-information Sorafenib (Nexavar) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *12 | + | *2005-12-20: Approved for the treatment of patients with advanced [[Renal cell carcinoma | renal cell carcinoma (RCC)]]. ''(Based on TARGET<sub>RCC</sub>)'' |
| − | *11 | + | *2007-11-16: Approved for the treatment of patients with unresectable [[Hepatocellular carcinoma| hepatocellular carcinoma (HCC)]]. ''(Based on SHARP)'' |
| − | *11 | + | *2013-11-22: Approved for the treatment of locally recurrent or metastatic, progressive, [[Thyroid cancer, differentiated| 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, [[Thyroid cancer, differentiated|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 [[Thyroid cancer, differentiated|differentiated thyroid carcinoma]]. | ||
| + | *2016-02-29: Revised indication for the treatment of unresectable [[thyroid cancer]]. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code names:''' BAY 43-9006, BAY 54-9085 | + | *'''Code names:''' BAY-43-9006, BAY-54-9085 |
*'''Brand names:''' Nexavar, Sorafenat, Soranib | *'''Brand names:''' Nexavar, Sorafenat, Soranib | ||
| Line 32: | Line 56: | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| − | |||
[[Category:BRAF inhibitors]] | [[Category:BRAF inhibitors]] | ||
| Line 43: | Line 66: | ||
[[Category:Acute myeloid leukemia medications]] | [[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:Hepatocellular carcinoma medications]] | ||
| − | [[Category:Non-small cell lung cancer medications]] | + | [[Category:Non-small cell lung cancer, nonsquamous medications]] |
| + | [[Category:Osteosarcoma medications]] | ||
| + | [[Category:Rectal cancer medications]] | ||
[[Category:Renal_cell_carcinoma medications]] | [[Category:Renal_cell_carcinoma medications]] | ||
[[Category:Thyroid cancer 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:FDA approved in 2005]] | ||
| + | [[Category:Health Canada approved in 2006]] | ||
| + | [[Category:PMDA approved in 2008]] | ||
Revision as of 01:02, 7 November 2023
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.[1][2][3]
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, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is established (work in progress)
Diseases for which it is used
- Acute myeloid leukemia
- Gastrointestinal stromal tumor
- Non-small cell lung cancer, nonsquamous
- Osteosarcoma
- Rectal cancer
- Soft tissue sarcoma
- Thyroid cancer
Patient drug information
- Sorafenib (Nexavar) package insert[1]
- Sorafenib (Nexavar) patient drug information (Chemocare)[4]
- Sorafenib (Nexavar) patient drug information (UpToDate)[5]
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: Nexavar, Sorafenat, Soranib
References
Categories:
- Drugs
- Oral medications
- BRAF inhibitors
- FLT3 inhibitors
- KIT inhibitors
- PDGFR inhibitors
- RAF1 inhibitors
- RET inhibitors
- VEGFR inhibitors
- Acute myeloid leukemia medications
- Clear cell renal cell carcinoma medications
- Desmoid tumor medications
- Gastrointestinal stromal tumor medications
- Hepatocellular carcinoma medications
- Non-small cell lung cancer, nonsquamous medications
- Osteosarcoma medications
- Rectal cancer medications
- Renal cell carcinoma medications
- Thyroid cancer medications
- Thyroid cancer, differentiated medications
- Thyroid cancer, medullary medications
- EMA approved in 2006
- FDA approved in 2005
- Health Canada approved in 2006
- PMDA approved in 2008