Difference between revisions of "Sorafenib (Nexavar)"
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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> | ||
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| + | ==Diseases for which it is established== | ||
| + | *[[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]] | *[[Gastrointestinal stromal tumor]] | ||
| − | |||
*[[Non-small cell lung cancer, nonsquamous]] | *[[Non-small cell lung cancer, nonsquamous]] | ||
*[[Osteosarcoma]] | *[[Osteosarcoma]] | ||
| − | |||
| − | |||
*Soft tissue sarcoma | *Soft tissue sarcoma | ||
**[[Desmoid tumors]] | **[[Desmoid tumors]] | ||
*[[Thyroid cancer]] | *[[Thyroid cancer]] | ||
| − | |||
**[[Medullary thyroid cancer]] | **[[Medullary thyroid cancer]] | ||
| Line 26: | Line 28: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *12/20/2005: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108538.htm FDA approved] | + | *12/20/2005: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108538.htm FDA approved] for the treatment of patients with advanced [[Renal cell carcinoma | renal cell carcinoma (RCC)]]. |
| − | *11/16/2007: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129234.htm FDA approved] | + | *11/16/2007: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm129234.htm FDA approved] for the treatment of patients with unresectable [[Hepatocellular carcinoma| hepatocellular carcinoma (HCC)]]. |
| − | *11/22/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376547.htm FDA approved] | + | *11/22/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm376547.htm FDA approved] for the treatment of locally recurrent or metastatic, progressive, [[Differentiated thyroid cancer| differentiated thyroid carcinoma (DTC)]] refractory to radioactive iodine treatment. |
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
Revision as of 02:18, 19 May 2022
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
Diseases for which it is used
- Acute myeloid leukemia
- Gastrointestinal stromal tumor
- Non-small cell lung cancer, nonsquamous
- Osteosarcoma
- 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
- 12/20/2005: FDA approved for the treatment of patients with advanced renal cell carcinoma (RCC).
- 11/16/2007: FDA approved for the treatment of patients with unresectable hepatocellular carcinoma (HCC).
- 11/22/2013: FDA approved for the treatment of locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment.
History of changes in EMA indication
- 7/19/2006: Initial marketing authorization as Nexavar
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
- Renal cell carcinoma medications
- Thyroid cancer medications
- Thyroid cancer, differentiated medications
- Medullary thyroid cancer medications
- EMA approved in 2006
- FDA approved in 2005