Difference between revisions of "Regorafenib (Stivarga)"
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<br>'''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.''' | <br>'''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 [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 package insert. | + | 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 package insert.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
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==Patient drug information== | ==Patient drug information== | ||
| − | *[http://labeling.bayerhealthcare.com/html/products/pi/Stivarga_PI.pdf | + | *[http://labeling.bayerhealthcare.com/html/products/pi/Stivarga_PI.pdf Regorafenib (Stivarga) package insert]<ref name="insert"></ref> |
*[http://www.chemocare.com/chemotherapy/drug-info/regorafenib.aspx Regorafenib (Stivarga) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/chemotherapy/drug-info/regorafenib.aspx Regorafenib (Stivarga) patient drug information (Chemocare)]</ref> | *[http://www.chemocare.com/chemotherapy/drug-info/regorafenib.aspx Regorafenib (Stivarga) patient drug information (Chemocare)]<ref>[http://www.chemocare.com/chemotherapy/drug-info/regorafenib.aspx Regorafenib (Stivarga) patient drug information (Chemocare)]</ref> | ||
*[http://www.uptodate.com/contents/regorafenib-patient-drug-information Regorafenib (Stivarga) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/regorafenib-patient-drug-information Regorafenib (Stivarga) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/regorafenib-patient-drug-information Regorafenib (Stivarga) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/regorafenib-patient-drug-information Regorafenib (Stivarga) patient drug information (UpToDate)]</ref> | ||
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*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 [[Sarcoma|gastrointestinal stromal tumors (GIST)]] that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease." | *2/25/2013: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm340958.htm FDA approved] for "patients with advanced [[Sarcoma|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 [[Hepatobiliary cancer|hepatocellular carcinoma (HCC)]] who have been previously treated with [[Sorafenib (Nexavar)|sorafenib]]." | ||
==Also known as== | ==Also known as== | ||
Revision as of 21:57, 27 April 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
BAY 73-4506.