Difference between revisions of "Irinotecan liposome (Onivyde)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Topoisomerase I inhibitor with [[Irinotecan (Camptosar)|irinotecan]] contained within a liposomal sphere. Irinotecan interferes with topoisomerase I's normal action of relieving torsional strain in DNA by creating reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I & DNA complex and interfere with ligation of these single-strand breaks. Failure to repair these breaks eventually leads to double-strand DNA damage, which disrupts cell proliferation and leads to cell death. In mouse models, 5 times lower doses of liposomal irinotecan were able to achieve similar intratumoral exposure levels of SN-38 as compared to irinotecan HCl.<ref name="insert">[https://www. | + | Class/mechanism: Topoisomerase I inhibitor with [[Irinotecan (Camptosar)|irinotecan]] contained within a liposomal sphere. Irinotecan interferes with topoisomerase I's normal action of relieving torsional strain in DNA by creating reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I & DNA complex and interfere with ligation of these single-strand breaks. Failure to repair these breaks eventually leads to double-strand DNA damage, which disrupts cell proliferation and leads to cell death. In mouse models, 5 times lower doses of liposomal irinotecan were able to achieve similar intratumoral exposure levels of SN-38 as compared to irinotecan HCl.<ref name="insert">[https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdf Irinotecan liposome (Onivyde) package insert]</ref><ref>[[:File:Irinotecanliposomal.pdf | Irinotecan liposome (Onivyde) package insert (locally hosted backup)]]</ref><ref>[https://www.onivyde.com/ Onivyde manufacturer's website]</ref><ref>[http://merrimackpharma.com/solutions/pipeline/mm-398 Merrimack Pharmaceuticals's MM-398 website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: no information available | <br>Extravasation: no information available | ||
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==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Esophageal cancer]] | *[[Esophageal cancer]] | ||
| + | **[[Esophageal adenocarcinoma]] | ||
*[[Gastric cancer]] | *[[Gastric cancer]] | ||
*[[Pancreatic cancer]] | *[[Pancreatic cancer]] | ||
==Patient drug information== | ==Patient drug information== | ||
| − | *Patient counseling information is available in the [https://www. | + | *Patient counseling information is available in the [https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207793lbl.pdf Irinotecan liposome (Onivyde) package insert]<ref name="insert"></ref> |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *10 | + | *2015-10-22: Approved in combination with [[Fluorouracil (5-FU)|fluorouracil (5FU)]] and [[Leucovorin (Folinic acid)|leucovorin (LV)]], for the treatment of patients with metastatic [[Pancreatic cancer|adenocarcinoma of the pancreas]] whose disease has progressed following [[Gemcitabine (Gemzar)|gemcitabine]]-based therapy. ''(Based on NAPOLI-1)'' |
| + | *2024-02-13: Approved with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic [[Pancreatic cancer|pancreatic adenocarcinoma]]. ''(Based on NAPOLI 3)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2016-10-14: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2017-08-09: Initial notice of compliance (unclear details) | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2020-03-25: Newly indicated for the treatment of unresectable [[pancreatic cancer]] that has progressed after cancer chemotherapy. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code names:''' MM-398 | + | *'''Code names:''' MM-398, PEP-02 |
| − | *'''Brand name:''' Onivyde | + | *'''Brand name:''' Onivyde, Onivyde pegylated liposomal |
==References== | ==References== | ||
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[[Category:Liposomal chemotherapy]] | [[Category:Liposomal chemotherapy]] | ||
| − | [[Category:Topoisomerase inhibitors]] | + | [[Category:Topoisomerase I inhibitors]] |
| + | [[Category:Esophageal adenocarcinoma medications]] | ||
[[Category:Esophageal cancer medications]] | [[Category:Esophageal cancer medications]] | ||
[[Category:Gastric cancer medications]] | [[Category:Gastric cancer medications]] | ||
[[Category:Pancreatic cancer medications]] | [[Category:Pancreatic cancer medications]] | ||
[[Category:FDA approved in 2015]] | [[Category:FDA approved in 2015]] | ||
| + | [[Category:EMA approved in 2016]] | ||
| + | [[Category:Health Canada approved in 2017]] | ||
| + | [[Category:PMDA approved in 2020]] | ||
Revision as of 19:56, 13 February 2024
General information
Class/mechanism: Topoisomerase I inhibitor with irinotecan contained within a liposomal sphere. Irinotecan interferes with topoisomerase I's normal action of relieving torsional strain in DNA by creating reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I & DNA complex and interfere with ligation of these single-strand breaks. Failure to repair these breaks eventually leads to double-strand DNA damage, which disrupts cell proliferation and leads to cell death. In mouse models, 5 times lower doses of liposomal irinotecan were able to achieve similar intratumoral exposure levels of SN-38 as compared to irinotecan HCl.[1][2][3][4]
Route: IV
Extravasation: no information available
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 used
Patient drug information
- Patient counseling information is available in the Irinotecan liposome (Onivyde) package insert[1]
History of changes in FDA indication
- 2015-10-22: Approved in combination with fluorouracil (5FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas whose disease has progressed following gemcitabine-based therapy. (Based on NAPOLI-1)
- 2024-02-13: Approved with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of metastatic pancreatic adenocarcinoma. (Based on NAPOLI 3)
History of changes in EMA indication
- 2016-10-14: Initial authorization
History of changes in Health Canada indication
- 2017-08-09: Initial notice of compliance (unclear details)
History of changes in PMDA indication
- 2020-03-25: Newly indicated for the treatment of unresectable pancreatic cancer that has progressed after cancer chemotherapy.
Also known as
- Code names: MM-398, PEP-02
- Brand name: Onivyde, Onivyde pegylated liposomal