Difference between revisions of "Regorafenib (Stivarga)"
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*[[Colon cancer]] | *[[Colon cancer]] | ||
*[[Gastric cancer]] | *[[Gastric cancer]] | ||
| − | *[[ | + | *[[Gastrointestinal stromal tumor]] |
| − | *[[ | + | *[[Hepatocellular carcinoma]] |
*[[Renal cancer]] | *[[Renal cancer]] | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*9/27/2012: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm321378.htm FDA approved] for "patients with metastatic [[Colon cancer|colorectal cancer (mCRC)]] who have been previously treated with fluoropyrimidine-, [[Oxaliplatin (Eloxatin)|oxaliplatin-]], and [[Irinotecan (Camptosar)|irinotecan-based]] chemotherapy, an [[:Category:VEGF_inhibitors|anti-VEGF therapy]], and, if KRAS wild type, an [[:Category:EGFR_inhibitors|anti-EGFR therapy]]." | *9/27/2012: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm321378.htm FDA approved] for "patients with metastatic [[Colon cancer|colorectal cancer (mCRC)]] who have been previously treated with fluoropyrimidine-, [[Oxaliplatin (Eloxatin)|oxaliplatin-]], and [[Irinotecan (Camptosar)|irinotecan-based]] chemotherapy, an [[:Category:VEGF_inhibitors|anti-VEGF therapy]], and, if KRAS wild type, an [[:Category:EGFR_inhibitors|anti-EGFR therapy]]." | ||
| − | *2/25/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340958.htm FDA approved] for "patients with advanced [[ | + | *2/25/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340958.htm FDA approved] for "patients with advanced [[Gastrointestinal stromal tumor|gastrointestinal stromal tumors (GIST)]] that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease." |
| − | *4/27/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555548.htm FDA approved] for "the treatment of patients with [[ | + | *4/27/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555548.htm FDA approved] for "the treatment of patients with [[Hepatocellular carcinoma|hepatocellular carcinoma (HCC)]] who have been previously treated with [[Sorafenib (Nexavar)|sorafenib]]." |
==Also known as== | ==Also known as== | ||
| − | BAY 73-4506 | + | *'''Code name:''' BAY 73-4506 |
==References== | ==References== | ||
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[[Category:Drug index]] | [[Category:Drug index]] | ||
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[[Category:Oral medications]] | [[Category:Oral medications]] | ||
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[[Category:Colon cancer medications]] | [[Category:Colon cancer medications]] | ||
[[Category:Gastric cancer medications]] | [[Category:Gastric cancer medications]] | ||
| − | [[Category: | + | [[Category:Gastrointestinal stromal tumor medications]] |
| + | [[Category:Hepatocellular carcinoma medications]] | ||
[[Category:Renal cancer medications]] | [[Category:Renal cancer medications]] | ||
| − | + | ||
[[Category:Drugs FDA approved in 2012]] | [[Category:Drugs FDA approved in 2012]] | ||
Revision as of 01:27, 1 December 2017
General information
Class/mechanism: Small molecule inhibitor of multiple tyrosine kinases, such as: VEGFR1, VEGFR2, VEGFR3, KIT, RET, PDGFR-alpha, PDGFR-beta, FGFR1, FGFR2, TIE2, DDR2, Trk2A, Eph2A, RAF-1, BRAF, BRAFV600E, SAPK2, PTK5, and Abl, which are involved in tumor cell proliferation, survival, and angiogenesis. Its major active metabolites are M-2 and M-5.[1][2][3]
Route: PO
Extravasation: n/a
Black Box Warning: Severe and sometimes fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue regorafenib for hepatotoxicity as manifested by elevated liver function tests (LFTs) or hepatocellular necrosis, depending upon severity and persistence.
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 package insert.[1]
Diseases for which it is used
Patient drug information
- Regorafenib (Stivarga) package insert[1]
- Regorafenib (Stivarga) patient drug information (Chemocare)[4]
- Regorafenib (Stivarga) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 9/27/2012: FDA approved for "patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy."
- 2/25/2013: FDA approved for "patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease."
- 4/27/2017: FDA approved for "the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib."
Also known as
- Code name: BAY 73-4506
References
- Drug index
- Oral medications
- Kinase inhibitors
- BRAF inhibitors
- FGFR inhibitors
- KIT inhibitors
- PDGFR inhibitors
- RET inhibitors
- TEK inhibitors
- VEGF inhibitors
- Colon cancer medications
- Gastric cancer medications
- Gastrointestinal stromal tumor medications
- Hepatocellular carcinoma medications
- Renal cancer medications
- Drugs FDA approved in 2012