Difference between revisions of "Oxaliplatin (Eloxatin)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Platinum analog, alkylating-like, which produces interstrand and intrastrand DNA crosslinks that inhibit DNA replication and transcription, causing non-cell cycle specific cytotoxicity and death.<ref name="insert">[http://products.sanofi.us/eloxatin/eloxatin.pdf Oxaliplatin (Eloxatin) package insert]</ref><ref>[ | + | Class/mechanism: Platinum analog, alkylating-like, which produces interstrand and intrastrand DNA crosslinks that inhibit DNA replication and transcription, causing non-cell cycle specific cytotoxicity and death.<ref name="insert">[http://products.sanofi.us/eloxatin/eloxatin.pdf Oxaliplatin (Eloxatin) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/oxaliplatin.pdf Oxaliplatin (Eloxatin) package insert (locally hosted backup)]</ref><ref>[http://www.eloxatin.com/ Eloxatin manufacturer's website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: [[irritant]] (usually), [[vesicant]] (rare) | <br>Extravasation: [[irritant]] (usually), [[vesicant]] (rare) | ||
| Line 37: | Line 37: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
===[[Colon cancer]]=== | ===[[Colon cancer]]=== | ||
| − | * 2004-11-04: New indication: used in combination with infusional [[Fluorouracil (5-FU) | 5-FU]]/[[Folinic acid | + | * 2004-11-04: New indication: used in combination with infusional [[Fluorouracil (5-FU) | 5-FU]]/[[Leucovorin (Folinic acid) | LV]], is indicated for adjuvant treatment of stage III [[Colon cancer | colon cancer]] patients who have undergone complete resection of the primary tumor. ''(Based on MOSAIC)'' |
===[[Colorectal cancer]]=== | ===[[Colorectal cancer]]=== | ||
| − | * 2002-08-09: Initial accelerated approval in combination with infusional [[Fluorouracil (5-FU) | 5-FU]]/[[Folinic acid | + | * 2002-08-09: Initial accelerated approval in combination with infusional [[Fluorouracil (5-FU) | 5-FU]]/[[Leucovorin (Folinic acid) | LV]], is indicated for the treatment of patients with metastatic [[Colorectal cancer|carcinoma of the colon or rectum]] whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus [[Fluorouracil (5-FU) | 5-FU]]/[[Leucovorin (Folinic acid) | LV]] and [[Irinotecan (Camptosar) | irinotecan]]. ''(Based on BRCC-00036)'' |
| − | **2004-01-09: Converted to regular approval in combination with infusional [[Fluorouracil (5-FU) | 5-FU]]/[[Folinic acid | + | **2004-01-09: Converted to regular approval in combination with infusional [[Fluorouracil (5-FU) | 5-FU]]/[[Leucovorin (Folinic acid) | LV]], is indicated for the treatment of advanced [[Colorectal cancer|carcinoma of the colon or rectum]]. ''(Based on NCCTG N9741)'' |
| + | ==History of changes in EMA indication== | ||
| + | *1996-04-12: EURD | ||
==History of changes in PMDA indication== | ==History of changes in PMDA indication== | ||
*2005-03-18: Initial approval for [[colorectal cancer|colonic and rectal cancers]]. | *2005-03-18: Initial approval for [[colorectal cancer|colonic and rectal cancers]]. | ||
| − | *2009-08-20: | + | *2009-08-20: New additional indication for post-operative adjuvant chemotherapy for [[colon cancer]]. |
| − | *2009-09-18: | + | *2009-09-18: New additional indication for combination therapy with other anticancer drugs (XELOX + BV regimen) for advanced or recurrent [[colorectal cancer]] not suited for curative resection. |
| − | *2013-12-20: | + | *2013-12-20: New additional indication and a new dosage for the treatment of unresectable [[pancreatic cancer]]. |
| − | *2015-03-20: | + | *2015-03-20: New additional indication and a new dosage for the treatment of unresectable advanced or recurrent [[gastric cancer]]. |
*2015-11-20: Revised indication for the treatment of [[gastric cancer]]. | *2015-11-20: Revised indication for the treatment of [[gastric cancer]]. | ||
| − | *2018-09-21: | + | *2018-09-21: New indication and a new dosage for the treatment of [[small intestine cancer]]. |
==Also known as== | ==Also known as== | ||
| Line 84: | Line 86: | ||
[[Category:FDA approved in 2002]] | [[Category:FDA approved in 2002]] | ||
| + | [[Category:EMA approved in 1996]] | ||
[[Category:PMDA approved in 2005]] | [[Category:PMDA approved in 2005]] | ||
[[Category:WHO Essential Cancer Medicine]] | [[Category:WHO Essential Cancer Medicine]] | ||
Revision as of 19:32, 23 June 2024
General information
Class/mechanism: Platinum analog, alkylating-like, which produces interstrand and intrastrand DNA crosslinks that inhibit DNA replication and transcription, causing non-cell cycle specific cytotoxicity and death.[1][2][3]
Route: IV
Extravasation: irritant (usually), vesicant (rare)
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
- Cholangiocarcinoma
- Chronic lymphocytic leukemia
- Diffuse large B-cell lymphoma
- Esophageal cancer
- Extranodal NK- and T-cell lymphoma, nasal type
- Gallbladder cancer
- Gastric cancer
- Mantle cell lymphoma
- Marginal zone lymphoma
- Nasopharyngeal carcinoma
- Pancreatic cancer
- Small intestine cancer
- Testicular cancer
- Transformed lymphoma
Patient drug information
- Oxaliplatin (Eloxatin) package insert PDF pages 15-16[1]
- Oxaliplatin (Eloxatin) patient drug information (Chemocare)[4]
- Oxaliplatin (Eloxatin) patient drug information (UpToDate)[5]
History of changes in FDA indication
Colon cancer
- 2004-11-04: New indication: used in combination with infusional 5-FU/ LV, is indicated for adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor. (Based on MOSAIC)
Colorectal cancer
- 2002-08-09: Initial accelerated approval in combination with infusional 5-FU/ LV, is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus 5-FU/ LV and irinotecan. (Based on BRCC-00036)
- 2004-01-09: Converted to regular approval in combination with infusional 5-FU/ LV, is indicated for the treatment of advanced carcinoma of the colon or rectum. (Based on NCCTG N9741)
History of changes in EMA indication
- 1996-04-12: EURD
History of changes in PMDA indication
- 2005-03-18: Initial approval for colonic and rectal cancers.
- 2009-08-20: New additional indication for post-operative adjuvant chemotherapy for colon cancer.
- 2009-09-18: New additional indication for combination therapy with other anticancer drugs (XELOX + BV regimen) for advanced or recurrent colorectal cancer not suited for curative resection.
- 2013-12-20: New additional indication and a new dosage for the treatment of unresectable pancreatic cancer.
- 2015-03-20: New additional indication and a new dosage for the treatment of unresectable advanced or recurrent gastric cancer.
- 2015-11-20: Revised indication for the treatment of gastric cancer.
- 2018-09-21: New indication and a new dosage for the treatment of small intestine cancer.
Also known as
- Code names: JM-83, RP-54780, SR-96669
- Brand names: Coxatin, Curaplat, Cure-X, Dacotin, Dacplat, Eloplat, Eloxatin, Eloxatine, Elplat, Oplatin, OxaLitin, Oxiplat, Oxitan, Oxzucia, Sibatin, Xaloplat, Xylotin, X-Plat, Zildox
References
Categories:
- Drugs
- Intravenous medications
- Platinum agents
- Cholangiocarcinoma medications
- Chronic lymphocytic leukemia medications
- Colon cancer medications
- Colorectal cancer medications
- Diffuse large B-cell lymphoma medications
- Esophageal adenocarcinoma medications
- Esophageal cancer medications
- Esophageal squamous cell carcinoma medications
- Extranodal NK- and T-cell lymphoma, nasal type medications
- Gallbladder cancer medications
- Gastric cancer medications
- Hepatocellular carcinoma medications
- Mantle cell lymphoma medications
- Marginal zone lymphoma medications
- Nasopharyngeal carcinoma medications
- Pancreatic cancer medications
- Rectal cancer medications
- Small intestine cancer medications
- Testicular cancer medications
- Transformed lymphoma medications
- FDA approved in 2002
- EMA approved in 1996
- PMDA approved in 2005
- WHO Essential Cancer Medicine